Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00347698
First received: June 30, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Drug: intravitreal injection of bevacizumab
Procedure: panretinal photocoagulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Complications associated to each treatment

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00347698     History of Changes
Other Study ID Numbers: APEC-007
Study First Received: June 30, 2006
Last Updated: June 30, 2006
Health Authority: Mexico: Ethics Committee
Mexico: Ministry of Health

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

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014