Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 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:
NCT00804206
First received: December 3, 2008
Last updated: December 5, 2008
Last verified: December 2008
  Purpose

Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.


Condition Intervention Phase
Macular Edema
Drug: bevacizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Central macular thickness [ Time Frame: baseline, 10 days, 52 days, 85 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: baseline, 10 days, 52 days, 85 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Bevacizumab before panretinal photocoagulation.
Drug: bevacizumab
Intravitreal bevacizumab before panretinal photocoagulation
Experimental: Group B
Bevacizumab after panretinal photocoagulation
Drug: bevacizumab
Intravitreal Bevacizumab after panretinal photocoagulation

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with proliferative diabetic retinopathy
  • patients with macular edema

Exclusion Criteria:

  • patients with previous treatments
  • patients with ocular surgeries
  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: NCT00804206

Contacts
Contact: Miriam Jessica López-Miranda, MD 10841400 ext 1171 jessicalop@hotmail.com

Locations
Mexico
Asociación para Evitar la Ceguera en México Recruiting
México, Mexico, 04030
Contact: Miriam Jessica López-Miranda, MD    10841400 ext 1171    jessicalop@hotmail.com   
Sub-Investigator: Fernando Hernandez-Miranda, MD         
Principal Investigator: Miriam Jessica López-Miranda, MD         
Sub-Investigator: José Luis Guerrero-Naranjo, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
  More Information

No publications provided

Responsible Party: Asociación para evitar la ceguera en mexico, APEC
ClinicalTrials.gov Identifier: NCT00804206     History of Changes
Other Study ID Numbers: APEC-040
Study First Received: December 3, 2008
Last Updated: December 5, 2008
Health Authority: Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:
Intravitreal injection of Bevacizumab
Visual acuity
central retinal thickness
color studies, Farnsworth-Munsell
electroretinogram studies

Additional relevant MeSH terms:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye 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 October 01, 2014