Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy

Last updated: May 29, 2024
Sponsor: Asociación para Evitar la Ceguera en México
Overall Status: Trial Not Available

Phase

2/3

Condition

Diabetic Retinopathy

Retina

Treatment

panretinal photocoagulation

intravitreal injection of bevacizumab

Clinical Study ID

NCT00347698
APEC-007
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • symmetric proliferative diabetic retinopathy without high risk characteristics

  • age 18 years or older

  • patient consent

Exclusion

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

Study Design

Treatment Group(s): 2
Primary Treatment: panretinal photocoagulation
Phase: 2/3
Study Start date:
March 01, 2006
Estimated Completion Date:
August 31, 2007

Study Description

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.

Connect with a study center

  • Asociación para Evitar la Ceguera en México

    Mexico City, D. F 04030
    Mexico

    Site Not Available

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