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NCT00347165 Clinical Trial

Intravitreal Bevacizumab for Age-Related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

Official title:
Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00347165
Other study ID # AvastinDMRE
Secondary ID
Status Recruiting
Phase Phase 2
First received June 29, 2006
Last updated June 30, 2006
Start date September 2005
Est. completion date September 2006

Study information
Verified date June 2006
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether intravitreal injection of bevacizumab is effective in the treatment of 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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- age >50 age related macular degeneration

Exclusion Criteria:

- moderate to severe cataract glaucoma intraocular surgery diabetes mellitus non controlled hypertension coronary artery disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab intravitreal injection

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 Improvement of visual acuity at 6 months
Secondary Retinal thickness at 6 months
Secondary Leakiness in fluorangiography at 6 months
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