Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Treatments: Procedure: panretinal photocoagulation; Drug: Aflibercept intravitreal injections

Study type: Interventional

Funder types: Other

Identifiers

NCT02151695

mEdICARE

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Panretinal photocoagulation

Active Comparator group

Treatment:

Procedure: panretinal photocoagulation

Aflibercept intravitreal injections

Experimental group

Treatment:

Drug: Aflibercept intravitreal injections