Intravitreal Bevacizumab for Diabetic Retinopathy

NCT ID: NCT00600262

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Nonproliferative Proliferative Diabetic Retinopathy Active Photocoagulated Diabetic Retinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intravitreal bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Principal Investigators

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Elizabeth Reyna-Castelan, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para evitar la ceguera en Mexico

Mariana Martinez-Castellanos, MD

Role: STUDY_CHAIR

Asociación para Evitar la Ceguera en México

Locations

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Elizabeth Reyna Castelan

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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APEC-004

Identifier Type: -

Identifier Source: org_study_id

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