Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Unknown status

CT.gov ID

NCT00347399

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Mar 1, 2006

Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Visual acuity improvement at 6 months []

Secondary Outcome Measures

Retinal thickness improvement at 6 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Luis Sanchez Bulnes	Mexico city	DF	Mexico	04030

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