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NCT00347399 Clinical Trial

Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

Official title:
Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00347399
Other study ID # AvastinTFD
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 2006
Est. completion date June 30, 2007

Study information
Verified date May 2024
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date June 30, 2007
Est. primary completion date June 30, 2006
Accepts healthy volunteers No
Gender All
Age group 55 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab intravitreal injection

Procedure:
• verteporfin photodynamic therapy

Locations
Country Name City State
Mexico Hospital Luis Sanchez Bulnes Mexico city DF

Sponsors (1)
Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity improvement at 6 months undefined undefined
Secondary Retinal thickness improvement at 6 months undefined undefined
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