Clinical trial

Intravitreal Bevacizumab vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-year Prospective, Contralateral Eye Study

Name

APEC-007

Description

The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.

Trial arms

Trial start

2006-03-01

Estimated PCD

2006-03-01

Trial end

2007-08-01

Status

Withdrawn

Phase

Early phase I

Treatment

intravitreal injection of bevacizumab

panretinal photocoagulation

Primary endpoint

Best corrected visual acuity at six months and one year

Macular thickness measured by OCT at six months and one year

Median deviation in visual fields at one year

Score on a patient satisfaction scale at six months and one year

Eligibility criteria

Inclusion Criteria: * symmetric proliferative diabetic retinopathy without high risk characteristics * age 18 years or older * patient consent Exclusion Criteria: * heart attack or cerebrovascular attack * only eye * retinal detachment * vitreous haemorrhage * previous treatment for diabetic retinopathy * media opacities that preclude visualization of the fundus * pregnancy * inability to understands the implications of the protocol

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-05-30

1 organization

1 product

1 indication

Organization

Asociación para Evitar la Ceguera en México

Product

Bevacizumab

Indication

Diabetic Retinopathy