Triple Combination Therapy of Choroidal Neovascularization in AMD, a Cost Effect and Efficient Therapeutic Treatment

April 5, 2016 updated by: The Retina Center of St. Louis County, PC

Triple Combination Therapy of Choroidal Neovascularization in Exudative Age-related Macular Degeneration - a Cost Effect and Efficient Therapeutic Treatment

We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an additional group of approximately 200 patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study parameters will include best corrected visual acuity, number of combination treatments, reduction of central foveal thickness by OCT measurement and development of exudative macular degeneration in the fellow eye. Follow up will include all patients with a minimum of two years. Retrospective review of patient charts in the office of The Retina Center.

Study Type

Observational

Enrollment (Actual)

400

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

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63141
        • The Retina Center

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

Sampling Method

Non-Probability Sample

Study Population

PATIENTS MUST HAVE A DIAGNOSIS CODE OF AGE RELATED MACULAR DEGENERATION AND MUST BE 50 YEARS OR OLDER AND HAVE EXUDATIVE AMD IN ATLEAST ONE EYE

Description

Inclusion Criteria:

- MUST HAVE AGE RELATED MACULAR DEGENERATION

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2006 TO 2010 PATIENTS
PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY
Procedure: TRIPLE COMBINATION THERAPY
TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY
CURRENT PATIENTS
PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY AND ADDITION OF 20 MG OF ORAL ZEAXANTHIN
Procedure: TRIPLE COMBINATION THERAPY
TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BEST CORRECTED VISUAL ACUITY
Time Frame: REVIEW OF EXAMINATION SHEETS
REVIEW OF EXAMINATION SHEETS

Secondary Outcome Measures

Outcome Measure
Time Frame
NUMBER OF COMBINATION TREATMENTS
Time Frame: REVIEW OF CHART
REVIEW OF CHART
REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT
Time Frame: REVIEW OF CHART
REVIEW OF CHART
DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE
Time Frame: REVIEW OF CHART
REVIEW OF CHART

Collaborators and Investigators

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

Sponsor

The Retina Center of St. Louis County, PC

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

August 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-07-0540

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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