Intravitreal Bevacizumab for Diabetic Retinopathy

NCT00600262 | Terminated Phase 2

• 1 other identifier: APEC-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Nonproliferative; Proliferative Diabetic Retinopathy; Active Photocoagulated Diabetic Retinopathy

Keywords

severe nonproliferative; proliferative diabetic retinopathy; active photocoagulated diabetic retinopathy; intravitreal bevacizumab

Interventions

intravitreal bevacizumab DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Elizabeth Reyna Castelan

Mexico City, 04030, Mexico

Location

Study Officials

• Elizabeth Reyna-Castelan, MD

  Asociación para evitar la ceguera en Mexico

  PRINCIPAL INVESTIGATOR

• Mariana Martinez-Castellanos, MD

  Asociación para Evitar la Ceguera en México

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: January 24, 2008
• Study Start: December 1, 2005
• Study Completion: June 1, 2006
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)