Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Phase 2

Completed

• Conditions: Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy
• Interventions: Procedure: panretinal photocoagulation; Drug: Aflibercept intravitreal injections

• Registration Number: NCT02151695
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Study Start: 2015-05
• Primary Completion: 2018-10-31
• Status Verified: 2019-03
• Study Completion: 2020-03-06
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Patients with diabetes mellitus type 1 or type 2 complicated by PDR
• Male or female over 18 years
• HbA1c <11.6% at study entry
• Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
• Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality

Exclusion Criteria

• Hypersensitivity to aflibercept or to any of the excipients
• History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
• PDR associated with tractional retinal detachment in the eye studied
• PDR associated with fibrovascular proliferation in the eye studied
• Florid diabetic retinopathy
• Eye infection or periocular active or suspected
• Unbalanced glaucoma in the eye studied
• Other eye disease in the eye studied
• Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panretinal photocoagulation	panretinal photocoagulation	-
Aflibercept intravitreal injections	Aflibercept intravitreal injections	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.	12 months

Trial Locations

Locations (1)

Chu de Poitiers; 🇫🇷 Poitiers, France