Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome (IVL for OHS)

Retina Associates of Kentucky

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ocular Histoplasmosis Syndrome

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00955630

FVF 4147S

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.

Full description

Patients will be evaluated monthly for one year.

Participants will be assigned to one of two groups:

Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study

You cannot take part in this study if:

1. You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
2. You are under the age of 18

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18 or over
• active choroidal neovascularization secondary to ocular histoplasmosis
• Visual acuity between 20/25 and 20/400

Exclusion criteria

• pregnancy or intent to become pregnant within the next 12 months
• nursing an infant
• premenopausal women not using contraception
• prior treatment with subfoveal thermal laser
• allergy to sodium fluorescein simultaneous participation in another investigation or trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Monthly injections

Active Comparator group

Description:

3 monthly injections of ranibizumab followed by prn injections

Treatment:

Drug: ranibizumab

Drug: ranibizumab

PRN injections

Active Comparator group

Description:

injections of ranibizumab on a prn basis from the start of the study

Treatment:

Drug: ranibizumab

Drug: ranibizumab