Treatment for Presumed Ocular Histoplasmosis

Phase 1

• Conditions: Ocular Histoplasmosis
• Interventions: Drug: aflibercept

• Registration Number: NCT01790893
• Lead Sponsor: John Kitchens, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Study Start: 2013-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
• Active CNV may also be defined as demonstrating active subretinal hemorrhage.
• ETDRS Best corrected visual acuity 20/20-20/320.
• willing and able to comply with all study clinic visits and study related procedures.
• Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
• Provide signed informed consent
• Able to understand and complete study related questionnaires

Exclusion Criteria

• Under 18 years of age
• CNV due to other causes than Presumed Ocular Histoplasmosis
• Previous treatment in the study eye within 6 months prior to Day 1
• More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
• Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
• History of allergy to fluorescein
• Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women
• Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.
• Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravitreal aflibercept	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.
intravitreal aflibercept injection	aflibercept	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. .

Primary Outcome Measures

Name	Time	Method
ocular and systemic adverse events	through Month 12	The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12

Secondary Outcome Measures

Name	Time	Method
Visual acuity	Months 3, 6, 9 and 12	* Mean change in BCVA from Baseline; * Proportion of subjects gaining \>5,10 and 15 letters; * Proportion of subjects losing \>5, 10 and 15 letters

Trial Locations

Locations (3)

Southeast Retina; 🇺🇸 Augusta, Georgia, United States

Retina Associates of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Cincinnati Eye Institute; 🇺🇸 Cincinnati, Ohio, United States