Intravitreal Bevacizumab for Age-Related Macular Degeneration

June 30, 2006 updated by: Asociación para Evitar la Ceguera en México

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • MExico city, DF, Mexico, 04030
        • Recruiting
        • Hospital Luis Sanchez Bulnes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of visual acuity at 6 months

Secondary Outcome Measures

Outcome Measure
Retinal thickness at 6 months
Leakiness in fluorangiography at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Study Chair: Hugo Quiroz-Mercado, MD, Asociación Para Evitar la Ceguera en México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

June 30, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AvastinDMRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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