Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 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:
NCT00347399
First received: June 30, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Asociacion Para Evitar La Ceguera en Mexico
Principal Investigator: Jose Dalma Weizhaus, MD Asociacion Para Evitar La Ceguera en Mexico
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00347399     History of Changes
Other Study ID Numbers: AvastinTFD
Study First Received: June 30, 2006
Last Updated: June 30, 2006
Health Authority: Mexico: Ministry of Health

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Bevacizumab
Verteporfin
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014