Clinical trial

Efficacy of Intravitreal Bevacizumab for Severe Nonproliferative and Proliferative Diabetic Retinopathy.

Name
APEC-004
Description
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.
Trial arms
Trial start
2005-12-01
Trial end
2006-06-01
Status
Terminated
Phase
Early phase I
Treatment
intravitreal bevacizumab
Size
-1
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}}
Updated at
2024-05-30

1 organization

1 product

2 indications