Treatment for Presumed Ocular Histoplasmosis

Part of paid clinical trials in Augusta, Georgia.

Sponsor: John Kitchens, MD
Study ID: NCT01790893
Phase: PHASE1/PHASE2
Status: Unknown

Conditions

Ocular Histoplasmosis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Accepted

Interventions

aflibercept — DRUG

Study Details

The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.

Key Dates

Start date: Mar 31, 2013
Status verified: Jun 2014
Primary completion: Aug 31, 2014
Completion: Aug 31, 2014

Study Design

Enrollment: 40 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: intravitreal aflibercept injection
Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection. .
Experimental: intravitreal aflibercept
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.

Primary Outcome Measure

ocular and systemic adverse events [ Time Frame: through Month 12 ]

Central Contacts

Diana Holcomb, COA
859-264-2905
[email protected]

Locations (3)

Facility	City	State	ZIP	Site coordinators
Southeast Retina	Augusta	Georgia	30909	Jared Gardner [email protected] 706-650-0061 Courtney Caulder [email protected] 706-650-0061 Dennis Marcus, MD (PRINCIPAL_INVESTIGATOR) Harinderjit Singh, MD (SUB_INVESTIGATOR)
Retina Associates of Kentucky	Lexington	Kentucky	40509	Diana Holcomb [email protected] 859-264-2905 John W. Kitchens, MD (PRINCIPAL_INVESTIGATOR) William J Wood, MD (SUB_INVESTIGATOR) Tom Stone, MD (SUB_INVESTIGATOR) Rick Isernhagen, MD (SUB_INVESTIGATOR) Andrew Moshfeghi, MD (SUB_INVESTIGATOR)
Cincinnati Eye Institute	Cincinnati	Ohio	45242	Megan Kingdon 513-569-3669 Daniel Miller, MD (PRINCIPAL_INVESTIGATOR) Michael Petersen, MD, PhD (SUB_INVESTIGATOR) Robert Sisk, MD (SUB_INVESTIGATOR) Robert Foster, MD (SUB_INVESTIGATOR) Christopher Riemann, MD (SUB_INVESTIGATOR) Brian Toussaint, MD (SUB_INVESTIGATOR)

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By research site

Southeast Retina· Augusta, GA Retina Associates of Kentucky· Lexington, KY Cincinnati Eye Institute· Cincinnati, OH