Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

Phase 1

• Conditions: Ocular Histoplasmosis Syndrome
• Interventions: Drug: ranibizumab

• Registration Number: NCT00955630
• Lead Sponsor: Retina Associates of Kentucky

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Last Update Submitted: 2009-08-07
• Study First Posted: 2009-08-10
• Last Update Posted: 2009-08-10
• Primary Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRN injections	ranibizumab	injections of ranibizumab on a prn basis from the start of the study
Monthly injections	ranibizumab	3 monthly injections of ranibizumab followed by prn injections

Primary Outcome Measures

Name	Time	Method
incidence and severity of ocular adverse events as identified by eye examination	1 year
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs	12 mos

Secondary Outcome Measures

Name	Time	Method
mean change in visual acuity	1 year
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography	6 and 12 months
change in fluorescein angiographic outcomes	12 months
mean number of injections	12 mos

Trial Locations

Locations (1)

Retina Associates of Kentucky; 🇺🇸 Lexington, Kentucky, United States