Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Sponsor
Poitiers University Hospital
Study ID
NCT02151695
Phase
PHASE2
Status
Completed

Conditions

  • Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Mar 2019
Primary completion
Oct 31, 2018
Completion
Mar 6, 2020

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Panretinal photocoagulation
  • Experimental: Aflibercept intravitreal injections

Primary Outcome Measure

Percentage of patients with regression of retinal neovascularization between baseline and 12th month. [ Time Frame: 12 months ]