Efficacy and safety of Aflibercept (Eylea®) in proliferative diabetic retinopathy

• Conditions: Percentage of patients showing regression of retinal neovascularization between baseline and month 12 in the Aflibercept group versus laser group; MedDRA version: 18.1Level: LLTClassification code 10036857Term: Proliferative diabetic retinopathySystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2013-001856-36-FR
• Lead Sponsor: CHU DE POITIERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-16
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diabetic patients with proliferative diabetic retinopathy
- Aged 18 years old or more
- Best corrected visual acuity score = 35 letters
- Glycosylated hemoglobin rate < 11% at inclusion
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 105 mmHg at inclusion
- Clear ocular media allowing fundus examination

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Any history of retinal laser photocoagulation
- Any history of intravitreal injection
- Any history of vitrectomy
- proliferative diabetic retinopathy associated to retinal detachment
- proliferative diabetic retinopathy associated to fibrovascular proliferation
- florid proliferative diabetic retinopathy
- Allergy to fluorescein
- Active infectious disease
- Any significant recent (less than 3 months) cardiovascular disorder (angina pectoris, myocardial infarction, renal failure)
- Any ocular disorder that could prevent retinal examination (cataract)
- Significant macular edema =350 µm.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified