NCT02287298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

September 19, 2014

Last Update Submit

April 5, 2016

Conditions

Exudative Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • BEST CORRECTED VISUAL ACUITY

    REVIEW OF EXAMINATION SHEETS

Secondary Outcomes (3)

  • NUMBER OF COMBINATION TREATMENTS

    REVIEW OF CHART

  • REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT

    REVIEW OF CHART

  • DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE

    REVIEW OF CHART

Study Arms (2)

2006 TO 2010 PATIENTS

PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY

Procedure: TRIPLE COMBINATION THERAPY

CURRENT PATIENTS

PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY AND ADDITION OF 20 MG OF ORAL ZEAXANTHIN

Procedure: TRIPLE COMBINATION THERAPY

Interventions

TRIPLE COMBINATION THERAPYPROCEDURE

TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY

2006 TO 2010 PATIENTSCURRENT PATIENTS

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \- MUST HAVE AGE RELATED MACULAR DEGENERATION

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Retina Center

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • ROBERT J OLK, MD

    THE RETINA CENTER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2014

First Posted

November 10, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)