Efficacy of Retreatments With Intravitreal Bevacizumab
May 31, 2024 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
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
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 Locations
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DF
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Mexico DF, DF, Mexico, 04030
- Asociación Para Evitar la Ceguera en México
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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
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 |
|---|
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Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Veronica Kon-Jara, MD, 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 (Actual)
May 1, 2006
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
November 30, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (Estimated)
December 4, 2006
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Metaplasia
- Macular Degeneration
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
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.