Intravitreal Bevacizumab for Age-Related Macular Degeneration - Full Text View

Sponsored by:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00347165

Purpose

The purpose of this study is to determine whether intravitreal injection of bevacizumab is effective in the treatment of neovascular age related macular degeneration

Condition	Intervention	Phase
Age Related Macular Degeneration	Drug: bevacizumab intravitreal injection	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:

Improvement of visual acuity at 6 months

Secondary Outcome Measures:

Retinal thickness at 6 months
Leakiness in fluorangiography at 6 months

Estimated Enrollment:	50
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2006

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347165

Locations

Mexico, DF
Hospital Luis Sanchez Bulnes	Recruiting
MExico city, DF, Mexico, 04030
Contact: Hugo Quiroz-Mercado, MD 525510841400 ext 1171 retinamex@yahoo.com

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Study Chair:

Hugo Quiroz-Mercado, MD

Asociacion para evitar la ceguera en Mexico

More Information

Publications:

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.

Study ID Numbers:	AvastinDMRE
Study First Received:	June 29, 2006
Last Updated:	June 30, 2006
ClinicalTrials.gov Identifier:	NCT00347165
Health Authority:	Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:

macular degeneration
angiogenesis
antibodies

Study placed in the following topic categories:

Antibodies
Eye Diseases
Retinal Degeneration
Macular Degeneration

Bevacizumab
Retinal Diseases
Immunoglobulins
Retinal degeneration

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009