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Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

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. Identifier: NCT00347399
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
Information provided by:
Asociación para Evitar la Ceguera en México

Brief Summary:
The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: bevacizumab intravitreal injection Procedure: verteporfin photodynamic therapy Phase 2

Detailed Description:
The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy
Study Start Date : March 2006
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Visual acuity improvement at 6 months

Secondary Outcome Measures :
  1. Retinal thickness improvement at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR)

Exclusion Criteria:

  • Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

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 identifier (NCT number): NCT00347399

Contact: Dalma Jose Dalma-Weizhaus 10841400 ext 1171

Hospital Luis Sanchez Bulnes Recruiting
Mexico city, DF, Mexico, 04030
Contact: Hugo Quiroz-Mercado, MD    525510841400   
Principal Investigator: Maura L Abraham Marin, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Study Director: Hugo Quiroz-Mercado, MD Asociación para Evitar la Ceguera en México
Principal Investigator: Jose Dalma Weizhaus, MD Asociación para Evitar la Ceguera en México

Publications: Identifier: NCT00347399     History of Changes
Other Study ID Numbers: AvastinTFD
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
macular degeneration
angiogenesis inhibitor

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents