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Aflibercept Injection for Proliferative Diabetic Retinopathy

Primary Purpose

Vitreous Hemorrhage

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravitreal Aflibercept Injection
Standard Vitrectomy
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Hemorrhage focused on measuring Proliferative Diabetic Retinopathy

Eligibility Criteria

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

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV)
  • Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

  • Pregnancy (positive urine pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
  • Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study
  • For previously treated subjects -
  • Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening
  • Prior treatment with triamcinolone in the study eye within 6 months of Screening.
  • Prior treatment with dexamethasone in the study eye within 30 days of Screening
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for PDR in the study eye
  • Active intraocular inflammation (grade trace or above) in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30 mmHg despite treatment with anti-glaucoma medication)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
  • History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to treatment
  • Presence of macular traction
  • Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV)
  • Concomitant use of any systemic anti-VEGF therapy

Sites / Locations

  • Dean McGee Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vitrectomy with Aflibercept Injection

Standard Vitrectomy

Arm Description

Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.

Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.

Outcomes

Primary Outcome Measures

Rate of Resolved Post-operative Vitreous Hemorrhage.
Percentage of patients who had no vitreous hemorrhage before or at week 24

Secondary Outcome Measures

Mean Change in Visual Acuity
Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased.
Need for Any Additional Surgical Intervention.
Changes in Mean Central Retinal Thickness.
The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.

Full Information

First Posted
February 26, 2013
Last Updated
August 14, 2017
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT01805297
Brief Title
Aflibercept Injection for Proliferative Diabetic Retinopathy
Official Title
Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Detailed Description
Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitrectomy with Aflibercept Injection
Arm Type
Active Comparator
Arm Description
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Arm Title
Standard Vitrectomy
Arm Type
Active Comparator
Arm Description
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection
Other Intervention Name(s)
Eylea
Intervention Description
One time 2.0mg aflibercept injection, following pars plana vitrectomy.
Intervention Type
Other
Intervention Name(s)
Standard Vitrectomy
Intervention Description
Surgical intervention
Primary Outcome Measure Information:
Title
Rate of Resolved Post-operative Vitreous Hemorrhage.
Description
Percentage of patients who had no vitreous hemorrhage before or at week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean Change in Visual Acuity
Description
Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased.
Time Frame
24 weeks
Title
Need for Any Additional Surgical Intervention.
Time Frame
24 weeks
Title
Changes in Mean Central Retinal Thickness.
Description
The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV) Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart Exclusion Criteria: Pregnancy (positive urine pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch. Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study For previously treated subjects - Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening Prior treatment with triamcinolone in the study eye within 6 months of Screening. Prior treatment with dexamethasone in the study eye within 30 days of Screening Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline History of vitrectomy surgery, submacular surgery, or other surgical intervention for PDR in the study eye Active intraocular inflammation (grade trace or above) in the study eye History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30 mmHg despite treatment with anti-glaucoma medication) History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment. History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to treatment Presence of macular traction Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV) Concomitant use of any systemic anti-VEGF therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Leonard, MD
Organizational Affiliation
Dean McGee Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinay A Shah, MD
Organizational Affiliation
Dean McGee Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Aflibercept Injection for Proliferative Diabetic Retinopathy

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