Treatment for Presumed Ocular Histoplasmosis



Status:Completed
Conditions:Cardiology, Infectious Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:March 2013
End Date:August 2014
Contact:Diana Holcomb, COA
Email:dholcomb@retinaky.com
Phone:859-264-2905

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

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.


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
We found this trial at
3
sites
Cincinnati, Ohio 45242
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Cincinnati, OH
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Augusta, Georgia 30909
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Augusta, GA
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Lexington, Kentucky 40509
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Lexington, KY
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