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Efficacy of Retreatments With Intravitreal Bevacizumab

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406744
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asociación para Evitar la Ceguera en México
  Purpose
Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.

Condition Intervention Phase
Age Related Macular Degeneration Choroidal Neovascularization Drug: Intravitreal injection of Bevacizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments

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, OCT foveal thickness and fluorescein angiogram

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: November 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • * Any visual acuity

    • OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
    • Active angiogram leakage

Exclusion Criteria:

  • * Basal Inflammatory disease

    • Endoftalmitis history
    • Lesions bigger than 5400 u or with scarring greater than 50% of lesion.
  Contacts and Locations
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): NCT00406744


Contacts
Contact: Veronica A Kon-Jara, MD 525510841400 ext 1172 veronicakon@yahoo.com
Contact: Hugo Quiroz-Mercado, MD 525510841400 ext 1171 retinamex@yahoo.com

Locations
Mexico
Asociacion para Evitar la Ceguera en Mexico Recruiting
Mexico DF, DF, Mexico, 04030
Contact: Veronica Kon-Jara, MD    525510841400 ext 1171    veronicakon@yahoo.com   
Principal Investigator: Veronica Kon-Jara, MD         
Sub-Investigator: Mitzy Torres-Soriano, MD         
Sub-Investigator: Jose Luis Diaz-Rubio, MD         
Sub-Investigator: Myriam Hernandez, MD         
Sub-Investigator: Hugo Quiroz-Mercado, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Veronica Kon-Jara, MD APEC
  More Information

ClinicalTrials.gov Identifier: NCT00406744     History of Changes
Other Study ID Numbers: APEC-0012
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
Last Verified: November 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents