Treatment for Presumed Ocular Histoplasmosis

Study Overview
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Brief Summary
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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.

Official Title
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Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)

Conditions
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Ocular Histoplasmosis

Intervention / Treatment
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* Drug: aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravitreal aflibercept injection<br>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. . | Drug: aflibercept<br> <br> |
| Experimental: intravitreal aflibercept<br>Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months. | Drug: aflibercept<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular and systemic adverse events | The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12 | through Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Mean change in BCVA from Baseline Proportion of subjects gaining >5,10 and 15 letters Proportion of subjects losing >5, 10 and 15 letters | Months 3, 6, 9 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Histoplasmosis