search
Back to results

Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

Primary Purpose

Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Intravitreal bevacizumab
Small-gauge pars plana vitrectomy
Sponsored by
J. Fernando Arevalo, MD FACS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy focused on measuring Intravitreal Bevacizumab, Tractional Retinal Detachment, Proliferative Diabetic Retinopathy, Small gauge pars plana vitrectomy, Intraoperative bleeding, Post-operative vitreous hemorrhage, Visual acuity

Eligibility Criteria

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

Inclusion Criteria:

  1. Age >= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
  2. Diagnosis of diabetes mellitus (type 1 or type 2)
  3. At least one eye meets the study eye criteria
  4. One eye per patient will be included
  5. Able and willing to provide informed consent prior to any study-related procedures
  6. Best corrected visual acuity 20/40 or less
  7. Willing and able to comply with clinic visits and study-related procedures
  8. U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws

Exclusion Criteria:

Ocular Exclusion Criteria

The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):

  1. TRD is considered to be due to a cause other than diabetes.
  2. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
  3. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
  4. History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs.
  5. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization.
  6. History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization.
  7. Intraocular pressure >= 25 mmHg.
  8. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
  9. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or including hypertension, cardiovascular disease, and glycemic control.

Systemic Exclusion Criteria

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

  1. Significant renal disease, defined as a history of chronic renal failure requiring 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 hypertension, cardiovascular disease, and glycemic control).
  3. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
  4. Known allergy to any component of the study drug.
  5. Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
  6. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
  7. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  8. Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
  9. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  10. Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
  11. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
  12. Known allergy to any component of the study drug.
  13. Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
  14. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
  15. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  16. Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
  17. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  18. Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
  19. History of blood diseases associated with abnormal coagulation.
  20. Anti-coagulant therapy (warfarin or heparin).

Sites / Locations

  • King Khaled Eye Specialist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Study arm

Control arm

Arm Description

Intravitreal bevacizumab Small-gauge pars plana vitrectomy

Small-gauge pars plana vitrectomy

Outcomes

Primary Outcome Measures

Intraoperative bleeding
Total surgical time
Post-operative vitreous hemorrhage
Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
Visual acuity change
Mean change in best-corrected visual acuity (BCVA) at 12 months

Secondary Outcome Measures

Number of endodiathermy applications
Intraoperative breaks
Change in central macular thickness
Proportion of eyes gaining at least 15 letters of BCVA

Full Information

First Posted
October 25, 2013
Last Updated
October 7, 2018
Sponsor
J. Fernando Arevalo, MD FACS
Collaborators
Pan American Collaborative Retina Study Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01976923
Brief Title
Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Official Title
Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
J. Fernando Arevalo, MD FACS
Collaborators
Pan American Collaborative Retina Study Group

4. Oversight

5. Study Description

Brief Summary
The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In addition, post-operative rebleeding may be decreased.
Detailed Description
This will be a prospective, randomized, active-controlled study of 224 eyes of patients with the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility. Eligible patients will be examined at baseline to determine their ocular condition and randomized into 2 arms. Patients will be randomized in a 1:1 ratio to the study arm. Control arm: PPV without pre-operative bevacizumab (Sham injection). Study arm: Pre-operative bevacizumab (3-5 days) before PPV. In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS). The purpose of the current study is to determine the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Keywords
Intravitreal Bevacizumab, Tractional Retinal Detachment, Proliferative Diabetic Retinopathy, Small gauge pars plana vitrectomy, Intraoperative bleeding, Post-operative vitreous hemorrhage, Visual acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Active Comparator
Arm Description
Intravitreal bevacizumab Small-gauge pars plana vitrectomy
Arm Title
Control arm
Arm Type
Sham Comparator
Arm Description
Small-gauge pars plana vitrectomy
Intervention Type
Drug
Intervention Name(s)
Intravitreal bevacizumab
Intervention Description
A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.
Intervention Type
Procedure
Intervention Name(s)
Small-gauge pars plana vitrectomy
Primary Outcome Measure Information:
Title
Intraoperative bleeding
Time Frame
12 months
Title
Total surgical time
Time Frame
12 months
Title
Post-operative vitreous hemorrhage
Description
Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
Time Frame
12 months
Title
Visual acuity change
Description
Mean change in best-corrected visual acuity (BCVA) at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of endodiathermy applications
Time Frame
12 months
Title
Intraoperative breaks
Time Frame
12 months
Title
Change in central macular thickness
Time Frame
12 months
Title
Proportion of eyes gaining at least 15 letters of BCVA
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Molecules in the vitreous humor and epiretinal membranes
Description
We would now like to examine molecules in the vitreous humor and epiretinal membranes to gain insight and better assess the efficacy and outcomes of pre-operative intravitreal bevacizumab.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea. Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria One eye per patient will be included Able and willing to provide informed consent prior to any study-related procedures Best corrected visual acuity 20/40 or less Willing and able to comply with clinic visits and study-related procedures U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws Exclusion Criteria: Ocular Exclusion Criteria The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye): TRD is considered to be due to a cause other than diabetes. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy). An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.) History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization. History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization. Intraocular pressure >= 25 mmHg. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or including hypertension, cardiovascular disease, and glycemic control. Systemic Exclusion Criteria A participant is not eligible if any of the following exclusion criteria are present: Significant renal disease, defined as a history of chronic renal failure requiring 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 hypertension, cardiovascular disease, and glycemic control). Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry. Known allergy to any component of the study drug. Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110). Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months. Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry. Known allergy to any component of the study drug. Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110). Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months. Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study. History of blood diseases associated with abnormal coagulation. Anti-coagulant therapy (warfarin or heparin).
Facility Information:
Facility Name
King Khaled Eye Specialist Hospital
City
Riyadh
ZIP/Postal Code
11462
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22047908
Citation
Arevalo JF, Sanchez JG, Saldarriaga L, Berrocal MH, Fromow-Guerra J, Morales-Canton V, Wu L, Maia M, Saravia MJ, Bareno J; Pan American Collaborative Retina Study Group. Retinal detachment after bevacizumab. Ophthalmology. 2011 Nov;118(11):2304.e3-7. doi: 10.1016/j.ophtha.2011.05.015. No abstract available.
Results Reference
background
PubMed Identifier
21584260
Citation
Arevalo JF, Sanchez JG, Lasave AF, Wu L, Maia M, Bonafonte S, Brito M, Alezzandrini AA, Restrepo N, Berrocal MH, Saravia M, Farah ME, Fromow-Guerra J, Morales-Canton V. Intravitreal Bevacizumab (Avastin) for Diabetic Retinopathy: The 2010 GLADAOF Lecture. J Ophthalmol. 2011;2011:584238. doi: 10.1155/2011/584238. Epub 2011 Mar 30.
Results Reference
background
PubMed Identifier
19199897
Citation
Arevalo JF, Garcia-Amaris RA. Intravitreal bevacizumab for diabetic retinopathy. Curr Diabetes Rev. 2009 Feb;5(1):39-46. doi: 10.2174/157339909787314121.
Results Reference
background
PubMed Identifier
17965108
Citation
Arevalo JF, Maia M, Flynn HW Jr, Saravia M, Avery RL, Wu L, Eid Farah M, Pieramici DJ, Berrocal MH, Sanchez JG. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008 Feb;92(2):213-6. doi: 10.1136/bjo.2007.127142. Epub 2007 Oct 26.
Results Reference
background

Learn more about this trial

Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

We'll reach out to this number within 24 hrs