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Anti-VEGF vs. Prompt Vitrectomy for VH From PDR (AB)

Primary Purpose

Proliferative Diabetic Retinopathy, Vitreous Hemorrhage

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
2-mg Intravitreous Aflibercept Injection
Prompt Vitrectomy Plus Panretinal Photocoagulation
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Anti-VEGF, Vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age >= 18 years Participants <18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable.
  2. Diagnosis of diabetes mellitus (type 1 or type 2)

Any one of the following will be considered to be sufficient evidence that diabetes is present:

  • Current regular use of insulin for the treatment of diabetes
  • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  • Documented diabetes by American Diabetes Association and/or World Health Organization criteria 4. Able and willing to provide informed consent. 5. Patient is willing and able to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduled within that time frame.

    6. Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, for which intervention is deemed necessary.

    • Note: Prior panretinal photocoagulation is neither a requirement nor an exclusion.
    • Subhyaloid hemorrhage alone does not make an eye eligible; however, presence of subhyaloid hemorrhage in addition to the criteria above will not preclude participation provided the investigator is comfortable with either treatment regimen.

      7. Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 months to see if hemorrhage clears sufficiently with anti-vascular endothelial growth factor without having to proceed to vitrectomy).

      8. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and at least light perception.

      9. Investigators should use particular caution when considering enrollment of an eye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefits outweigh the potential risks.

Exclusion Criteria:

  • A potential participant is not eligible if any of the following exclusion criteria are present:

    1. History of chronic renal failure requiring dialysis (including placement of fistula if performed in preparation for dialysis) or kidney transplant.
    2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
    3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
    4. A condition that, in the opinion of the investigator, would preclude participant undergoing elective vitrectomy surgery if indicated during the study.
    5. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.

      • Note: participants cannot receive another investigational drug while participating in the study.

    6. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine).
    7. Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
    8. If blood pressure is brought below 180/110 by anti-hypertensive treatment, potential participant can become eligible.
    9. Systemic anti-vascular endothelial growth factor or pro-vascular endothelial growth factor treatment within 4 months prior to randomization.

      • These drugs cannot be used during the study.

    10. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next two years.

      • Women who are potential participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.

    11. Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the two years.
    12. Evidence of traction detachment involving or threatening the macula.

      • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.

    13. Evidence of rhegmatogenous retinal detachment.

      • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.

    14. Evidence of neovascular glaucoma (iris or angle neovascularization is not an exclusion).
    15. Known diabetic macular edema (DME), defined as either
    16. Optical coherence tomography central subfield thickness (microns):
    17. Zeiss Cirrus: ≥290 in women; ≥305 in men
    18. Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
    19. Diabetic macular edema on clinical exam that the investigator believes currently requires treatment.
    20. History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
    21. History of intraocular corticosteroid treatment within 4 months prior to current vitreous hemorrhage onset or after onset.
    22. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.
    23. History of vitrectomy.
    24. History of YAG capsulotomy performed within 2 months prior to randomization.
    25. Aphakia.
    26. Uncontrolled glaucoma (in investigator's judgment).
    27. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Sites / Locations

  • Retinal Diagnostic Center
  • Macula & Retina Institute
  • Atlantis Eye Care
  • Loma Linda University Health Care, Department of Ophthalmology
  • Shashi D Ganti, MD PC
  • Florida Retina Consultants
  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
  • Retina Associates of Sarasota
  • Retina Associates of Florida, P.A.
  • Emory Eye Center
  • Southeast Retina Center, P.C.
  • Marietta Eye Clinic
  • Thomas Eye Group
  • Gailey Eye Clinic
  • Northwestern Medical Faculty Foundation
  • University of Illinois at Chicago Medical Center
  • Carle Foundation Hospital
  • Raj K. Maturi, MD, PC
  • John-Kenyon American Eye Institute
  • Retina Associates, P.A.
  • Paducah Retinal Center
  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
  • Elman Retina Group, P.A.
  • Wilmer Eye Institute at Johns Hopkins
  • Valley Eye Physicians and Surgeons
  • Joslin Diabetes Center
  • Kellogg Eye Center, University of Michigan
  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
  • Retina Specialists of Michigan
  • Retina Center, PA
  • Mayo Clinic Department of Ophthalmology
  • Mid-America Retina Consultants, P.A.
  • The Retina Institute
  • The New York Eye and Ear Infirmary/Faculty Eye Practice
  • MaculaCare
  • Weill Cornell Medical College
  • Retina-Vitreous Surgeons of Central New York, PC
  • Kittner Eye Center
  • Charlotte Eye, Ear, Nose and Throat Assoc., PA
  • Retina Associates of Cleveland, Inc.
  • University Hospitals Cleveland Medical Center
  • Retina Vitreous Center
  • Dean A. McGee Eye Institute
  • Oregon Retina, LLP
  • Retina Northwest, PC
  • Casey Eye Institute
  • Retina Vitreous Consultants
  • Palmetto Retina Center
  • Southeastern Retina Associates
  • Southeastern Retina Associates, P.C.
  • Southwest Retina Specialists
  • Retina Research Center
  • Retina and Vitreous of Texas
  • Baylor Eye Physicians and Surgeons
  • Texas Retina Associates
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retinal Consultants of San Antonio
  • Spokane Eye Clinic
  • Medical College of Wisconsin
  • UBC/VCHA Eye Care Centre
  • University Health Network - Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravitreous 2 mg aflibercept injections

Prompt vitrectomy plus panretinal photocoagulation

Arm Description

Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.

For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.

Outcomes

Primary Outcome Measures

E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

Secondary Outcome Measures

E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity..
Recurrent Vitreous Hemorrhage
Assessed by the investigator and defined as presence of vitreous hemorrhage after a period of absence. Excludes eyes in which vitreous hemorrhage could not be assessed during follow-up.
Retinal Neovascularization on Clinical Exam
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined.
Retinal Neovascularization on Clinical Exam
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Retinal Neovascularization on Clinical Exam
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined

Full Information

First Posted
August 3, 2016
Last Updated
March 24, 2021
Sponsor
Jaeb Center for Health Research
Collaborators
National Institutes of Health (NIH), Regeneron Pharmaceuticals, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02858076
Brief Title
Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
Acronym
AB
Official Title
Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Institutes of Health (NIH), Regeneron Pharmaceuticals, National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.
Detailed Description
A participant could have only one eye enrolled in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Vitreous Hemorrhage
Keywords
Anti-VEGF, Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreous 2 mg aflibercept injections
Arm Type
Active Comparator
Arm Description
Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.
Arm Title
Prompt vitrectomy plus panretinal photocoagulation
Arm Type
Active Comparator
Arm Description
For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.
Intervention Type
Drug
Intervention Name(s)
2-mg Intravitreous Aflibercept Injection
Other Intervention Name(s)
Eylea, Vascular endothelial growth factor Trap-Eye
Intervention Description
Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
Intervention Type
Procedure
Intervention Name(s)
Prompt Vitrectomy Plus Panretinal Photocoagulation
Other Intervention Name(s)
PRP
Intervention Description
Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser
Primary Outcome Measure Information:
Title
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
Description
The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
E-ETDRS Visual Acuity Letter Score
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
4 Weeks
Title
E-ETDRS Visual Acuity Letter Score
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
12 Weeks
Title
E-ETDRS Visual Acuity Letter Score
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
24 Weeks
Title
E-ETDRS Visual Acuity Letter Score
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
1-Year from participant randomization
Title
E-ETDRS Visual Acuity Letter Score
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
2 Years
Title
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
2-Years
Title
Snellen Equivalent Range (Visual Acuity Score)
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
4 weeks
Title
Snellen Equivalent Range (Visual Acuity Score)
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
12 weeks
Title
Snellen Equivalent Range (Visual Acuity Score)
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
24 weeks
Title
Snellen Equivalent Range (Visual Acuity Score)
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time Frame
1 year
Title
Snellen Equivalent Range (Visual Acuity Score)
Description
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity..
Time Frame
2 years
Title
Recurrent Vitreous Hemorrhage
Description
Assessed by the investigator and defined as presence of vitreous hemorrhage after a period of absence. Excludes eyes in which vitreous hemorrhage could not be assessed during follow-up.
Time Frame
At any time through 2 years
Title
Retinal Neovascularization on Clinical Exam
Description
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined.
Time Frame
24 weeks
Title
Retinal Neovascularization on Clinical Exam
Description
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Time Frame
1 year
Title
Retinal Neovascularization on Clinical Exam
Description
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Participants <18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable. Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considered to be sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes Documented diabetes by American Diabetes Association and/or World Health Organization criteria 4. Able and willing to provide informed consent. 5. Patient is willing and able to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduled within that time frame. 6. Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, for which intervention is deemed necessary. Note: Prior panretinal photocoagulation is neither a requirement nor an exclusion. Subhyaloid hemorrhage alone does not make an eye eligible; however, presence of subhyaloid hemorrhage in addition to the criteria above will not preclude participation provided the investigator is comfortable with either treatment regimen. 7. Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 months to see if hemorrhage clears sufficiently with anti-vascular endothelial growth factor without having to proceed to vitrectomy). 8. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and at least light perception. 9. Investigators should use particular caution when considering enrollment of an eye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefits outweigh the potential risks. Exclusion Criteria: A potential participant is not eligible if any of the following exclusion criteria are present: History of chronic renal failure requiring dialysis (including placement of fistula if performed in preparation for dialysis) or kidney transplant. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months. A condition that, in the opinion of the investigator, would preclude participant undergoing elective vitrectomy surgery if indicated during the study. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied. • Note: participants cannot receive another investigational drug while participating in the study. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine). Blood pressure > 180/110 (systolic above 180 or diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, potential participant can become eligible. Systemic anti-vascular endothelial growth factor or pro-vascular endothelial growth factor treatment within 4 months prior to randomization. • These drugs cannot be used during the study. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next two years. • Women who are potential participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed. Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the two years. Evidence of traction detachment involving or threatening the macula. • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care. Evidence of rhegmatogenous retinal detachment. • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care. Evidence of neovascular glaucoma (iris or angle neovascularization is not an exclusion). Known diabetic macular edema (DME), defined as either Optical coherence tomography central subfield thickness (microns): Zeiss Cirrus: ≥290 in women; ≥305 in men Heidelberg Spectralis: ≥305 in women; ≥320 in men OR Diabetic macular edema on clinical exam that the investigator believes currently requires treatment. History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset. History of intraocular corticosteroid treatment within 4 months prior to current vitreous hemorrhage onset or after onset. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization. History of vitrectomy. History of YAG capsulotomy performed within 2 months prior to randomization. Aphakia. Uncontrolled glaucoma (in investigator's judgment). Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Antoszyk, MD
Organizational Affiliation
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Official's Role
Study Chair
Facility Information:
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Macula & Retina Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Atlantis Eye Care
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Loma Linda University Health Care, Department of Ophthalmology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Shashi D Ganti, MD PC
City
Porterville
State/Province
California
ZIP/Postal Code
93257
Country
United States
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Retina Associates of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Retina Associates of Florida, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southeast Retina Center, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Thomas Eye Group
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Gailey Eye Clinic
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Raj K. Maturi, MD, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
42690
Country
United States
Facility Name
John-Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Retina Associates, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Elman Retina Group, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Wilmer Eye Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Valley Eye Physicians and Surgeons
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Kellogg Eye Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Retina Specialists of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Retina Center, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic Department of Ophthalmology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mid-America Retina Consultants, P.A.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
The New York Eye and Ear Infirmary/Faculty Eye Practice
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
MaculaCare
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Retina-Vitreous Surgeons of Central New York, PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Kittner Eye Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Assoc., PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Retina Vitreous Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Retina, LLP
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Retina Northwest, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Retina Vitreous Consultants
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Southeastern Retina Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Southeastern Retina Associates, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Southwest Retina Specialists
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina and Vitreous of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Baylor Eye Physicians and Surgeons
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Retina Associates
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Spokane Eye Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
UBC/VCHA Eye Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33956075
Citation
Glassman AR, Beaulieu WT, Maguire MG, Antoszyk AN, Chow CC, Elman MJ, Jampol LM, Salehi-Had H, Sun JK; DRCR Retina Network. Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jul 1;139(7):725-733. doi: 10.1001/jamaophthalmol.2021.1110.
Results Reference
derived
PubMed Identifier
33320223
Citation
Antoszyk AN, Glassman AR, Beaulieu WT, Jampol LM, Jhaveri CD, Punjabi OS, Salehi-Had H, Wells JA 3rd, Maguire MG, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2020 Dec 15;324(23):2383-2395. doi: 10.1001/jama.2020.23027.
Results Reference
derived

Learn more about this trial

Anti-VEGF vs. Prompt Vitrectomy for VH From PDR

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