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Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT00347698
Recruitment Status : Unknown
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: intravitreal injection of bevacizumab Procedure: panretinal photocoagulation Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study
Study Start Date : March 2006
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources




Primary Outcome Measures :
  1. Best corrected visual acuity at six months and one year
  2. Macular thickness measured by OCT at six months and one year
  3. Median deviation in visual fields at one year
  4. Score on a patient satisfaction scale at six months and one year

Secondary Outcome Measures :
  1. Complications associated to each treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symmetric proliferative diabetic retinopathy without high risk characteristics
  • age 18 years or older
  • patient consent

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347698


Contacts
Contact: Gerardo García-Aguirre, MD +52 (55) 10841400 ext 1172 retinamex@yahoo.com
Contact: Elizabeth Reyna-Castelán, MD +52 (55)10841400 ext 1172 retinamex@yahoo.com

Locations
Mexico
Asociación para Evitar la Ceguera en México Recruiting
Mexico City, D. F, Mexico, 04030
Contact: Yoko Burgoa    +52 (55) 1084 1400 ext 1171    retinamex@yahoo.com   
Contact: Mariana Martinez, MD    +52 (55) 1084 1400 ext 1171    retinamex@yahoo.com   
Principal Investigator: Gerardo García-Aguirre, MD         
Sub-Investigator: Hugo Quiroz-Mercado, MD         
Sub-Investigator: Veronica Kon-Jara, MD         
Sub-Investigator: Mitzy Torres, MD         
Sub-Investigator: Elizabeth Reyna-Castelan, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Gerardo García-Aguirre, MD Asociación para Evitar la Ceguera en México

Publications:

ClinicalTrials.gov Identifier: NCT00347698     History of Changes
Other Study ID Numbers: APEC-007
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
diabetic retinopathy
bevacizumab
photocoagulation

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents