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Efficacy of Retreatments With Intravitreal Bevacizumab

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 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:
NCT00406744
First received: November 30, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00406744     History of Changes
Other Study ID Numbers: APEC-0012
Study First Received: November 30, 2006
Last Updated: November 30, 2006
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013