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

Completed

• Conditions: Exudative Macular Degeneration
• Interventions: Procedure: TRIPLE COMBINATION THERAPY

• Registration Number: NCT02287298
• Lead Sponsor: The Retina Center of St. Louis County, PC

Brief Summary

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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• MUST HAVE AGE RELATED MACULAR DEGENERATION

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CURRENT PATIENTS	TRIPLE COMBINATION THERAPY	PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY AND ADDITION OF 20 MG OF ORAL ZEAXANTHIN
2006 TO 2010 PATIENTS	TRIPLE COMBINATION THERAPY	PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY

Primary Outcome Measures

Name	Time	Method
BEST CORRECTED VISUAL ACUITY	REVIEW OF EXAMINATION SHEETS

Secondary Outcome Measures

Name	Time	Method
NUMBER OF COMBINATION TREATMENTS	REVIEW OF CHART
DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE	REVIEW OF CHART
REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT	REVIEW OF CHART

Trial Locations

Locations (1)

The Retina Center; 🇺🇸 St Louis, Missouri, United States