Treatment for Presumed Ocular Histoplasmosis (HANDLE)

John Kitchens, MD

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ocular Histoplasmosis

Treatments: Drug: aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT01790893

IND 117497

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

intravitreal aflibercept injection

Experimental group

Description:

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. .

Treatment:

Drug: aflibercept

intravitreal aflibercept

Experimental group

Description:

Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.

Treatment:

Drug: aflibercept