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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

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date July 4, 2006
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • 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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
Complications associated to each treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE
  • Drug: intravitreal injection of bevacizumab
  • Procedure: panretinal photocoagulation
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June 30, 2006)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347698
Other Study ID Numbers  ICMJE APEC-007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Asociación para Evitar la Ceguera en México
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerardo García-Aguirre, MD Asociación para Evitar la Ceguera en México
PRS Account Asociación para Evitar la Ceguera en México
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP