Triple Combination Therapy of Choroidal Neovascularizatio... | NCT02287298

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

NCT02287298

Sponsor

The Retina Center of St. Louis County, PC

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Exudative Macular Degeneration

Interventions

TRIPLE COMBINATION THERAPY

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 19, 2014

First Submission Date that Met QC Criteria

Nov 5, 2014

First Posted Date

Nov 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TRIPLE COMBINATION THERAPY	Procedure	TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY	2006 TO 2010 PATIENTS CURRENT PATIENTS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BEST CORRECTED VISUAL ACUITY		REVIEW OF EXAMINATION SHEETS

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- MUST HAVE AGE RELATED MACULAR DEGENERATION

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ROBERT J OLK, MD	THE RETINA CENTER	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Retina Center		St Louis	Missouri	63141	United States

Condition Browse Module

MeSH Terms

ID	Term
D057135	Wet Macular Degeneration

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided