Clinical Trial: Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study

Brief 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.

Detailed Summary: 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.
Sponsor: Asociación para Evitar la Ceguera en México

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Complications associated to each treatment

Original Secondary Outcome: Same as current

Information By: Asociación para Evitar la Ceguera en México

Dates:
Date Received: June 30, 2006
Date Started: March 2006
Date Completion: August 2007
Last Updated: June 30, 2006
Last Verified: June 2006