We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

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 June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347399
First Posted: July 4, 2006
Last Update Posted: July 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
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 Intervention Phase
Age Related Macular Degeneration Drug: bevacizumab intravitreal injection Procedure: verteporfin photodynamic therapy Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Visual acuity improvement at 6 months

Secondary Outcome Measures:
  • Retinal thickness improvement at 6 months

Estimated Enrollment: 25
Study Start Date: March 2006
Estimated Study Completion Date: June 2007
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  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): NCT00347399


Contacts
Contact: Dalma Jose Dalma-Weizhaus 10841400 ext 1171 draojitos26@hotmail.com

Locations
Mexico
Hospital Luis Sanchez Bulnes Recruiting
Mexico city, DF, Mexico, 04030
Contact: Hugo Quiroz-Mercado, MD    525510841400    retinamex@yahoo.com   
Principal Investigator: Maura L Abraham Marin, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00347399     History of Changes
Other Study ID Numbers: AvastinTFD
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: July 4, 2006
Last Verified: June 2006

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

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


To Top