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

This study is currently recruiting participants.

Verified by Asociación para Evitar la Ceguera en México, December 2008

First Received: December 3, 2008 Last Updated: December 5, 2008 History of Changes

Sponsored by:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00804206

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 IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

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
Group A: Experimental Bevacizumab before panretinal photocoagulation.	Drug: bevacizumab Intravitreal bevacizumab before panretinal photocoagulation
Group B: Experimental 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

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:	APEC ( Asociación para evitar la ceguera en mexico )
Study ID Numbers:	APEC-040
Study First Received:	December 3, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804206 History of Changes
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

Study placed in the following topic categories:

Macular Edema
Eye Diseases
Retinal Degeneration
Macular Degeneration

Edema
Bevacizumab
Angiogenesis Inhibitors
Retinal Diseases

Additional relevant MeSH terms:

Antineoplastic Agents
Eye Diseases
Growth Substances
Physiological Effects of Drugs
Macular Degeneration
Retinal Degeneration
Bevacizumab

Angiogenesis Inhibitors
Pharmacologic Actions
Macular Edema
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009