Efficacy of Retreatments With Intravitreal Bevacizumab

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

Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments

Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • DF
      • Mexico DF, DF, Mexico, 04030
        • Recruiting
        • Asociación Para Evitar la Ceguera en México
        • Contact:
        • Principal Investigator:
          • Veronica Kon-Jara, MD
        • Sub-Investigator:
          • Mitzy Torres-Soriano, MD
        • Sub-Investigator:
          • Jose Luis Diaz-Rubio, MD
        • Sub-Investigator:
          • Myriam Hernandez, MD

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

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • * Any visual acuity

    • OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
    • Active angiogram leakage

Exclusion Criteria:

  • * Basal Inflammatory disease

    • Endoftalmitis history
    • Lesions bigger than 5400 u or with scarring greater than 50% of lesion.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram

Collaborators and Investigators

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

Sponsor

Asociación para Evitar la Ceguera en México

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

May 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 30, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-0012

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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