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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00347165
Other study ID # AvastinDMRE
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2005
Est. completion date September 2006

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 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 Terminated
Enrollment 50
Est. completion date September 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 50 Years to 99 Years
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


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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