Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
NCT02151695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2020-03-10
Summary
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.
The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.
Conditions
- Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy
Interventions
- PROCEDURE
-
panretinal photocoagulation
- DRUG
-
Aflibercept intravitreal injections
Sponsors & Collaborators
-
Poitiers University Hospital
lead OTHER
Principal Investigators
-
Nicolas LEVEZIEL, MD, PhD · Poitiers University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2018-10-31
- Completion
- 2020-03-06
Countries
- France
Study Locations
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