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

Exudative Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287298
• Other study ID #: 14-07-0540
• Status: Completed
• Phase: N/A
• First received: September 19, 2014
• Last updated: April 5, 2016
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: The Retina Center of St. Louis County, PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• MUST HAVE AGE RELATED MACULAR DEGENERATION

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Exudative Macular Degeneration
• Macular Degeneration
• Neovascularization, Pathologic
• Wet Macular Degeneration

Intervention

Procedure:
• TRIPLE COMBINATION THERAPY
TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY

Locations

Country	Name	City	State
United States	The Retina Center	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
The Retina Center of St. Louis County, PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BEST CORRECTED VISUAL ACUITY		REVIEW OF EXAMINATION SHEETS	No
Secondary	NUMBER OF COMBINATION TREATMENTS		REVIEW OF CHART	No
Secondary	REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT		REVIEW OF CHART	No
Secondary	DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE		REVIEW OF CHART	No