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Intravitreal Bevacizumab for Age-Related Macular Degeneration

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
bevacizumab intravitreal injection
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring macular degeneration, angiogenesis, antibodies

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Luis Sanchez BulnesRecruiting

Outcomes

Primary Outcome Measures

Improvement of visual acuity at 6 months

Secondary Outcome Measures

Retinal thickness at 6 months
Leakiness in fluorangiography at 6 months

Full Information

First Posted
June 29, 2006
Last Updated
June 30, 2006
Sponsor
Asociación para Evitar la Ceguera en México
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1. Study Identification

Unique Protocol Identification Number
NCT00347165
Brief Title
Intravitreal Bevacizumab for Age-Related Macular Degeneration
Official Title
Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
macular degeneration, angiogenesis, antibodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bevacizumab intravitreal injection
Primary Outcome Measure Information:
Title
Improvement of visual acuity at 6 months
Secondary Outcome Measure Information:
Title
Retinal thickness at 6 months
Title
Leakiness in fluorangiography at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Luis Sanchez Bulnes
City
MExico city
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Phone
525510841400
Ext
1171
Email
retinamex@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
16156152
Citation
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.
Results Reference
background

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Intravitreal Bevacizumab for Age-Related Macular Degeneration

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