Treatment for Presumed Ocular Histoplasmosis

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: John Kitchens, MD
• Treatments: Aflibercept

Criteria

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