Intravitreal Bevacizumab for Diabetic Retinopathy

Asociación para Evitar la Ceguera en México

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Severe Nonproliferative; Proliferative Diabetic Retinopathy; Active Photocoagulated Diabetic Retinopathy

Treatments: Drug: intravitreal bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00600262

APEC-004

Details and patient eligibility

About

Background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on the progression of severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas and regression of retinal and disc neovasculrization.

Methods: 40 patients were enrolled in a prospective, interventional study. Patients were treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity, neovascularization leakage points, capillary closure ischemic areas and macular edema by clinical examination and fluorescein angiography. A clinical examination was performed at baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography at 30 days.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe nonproliferative
• Proliferative diabetic retinopathy
• Active photocoagulated diabetic retinopathy

Exclusion criteria

• Previous vascular occlusion
• Glaucoma
• Uncontrolled hypertension, thromboembolic event
• Renal abnormalities
• Recent or planned surgery
• Coagulation abnormalities
• Panretinal photocoagulation of less than one month before
• Patients with known serious allergies

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)