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

Sponsor

Retina Associates of Kentucky (Other)

Overall Status

Unknown status

CT.gov ID

NCT00955630

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Histoplasmosis Syndrome	Drug: ranibizumab Drug: ranibizumab	Phase 1/Phase 2

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Monthly injections 3 monthly injections of ranibizumab followed by prn injections	Drug: ranibizumab 3 monthly injections of ranibizumab followed by prn injections for the remainder of the study Other Names: Lucentis
Active Comparator: PRN injections injections of ranibizumab on a prn basis from the start of the study	Drug: ranibizumab prn injections of ranibizumab throughout the study Other Names: Lucentis

Arm

Intervention/Treatment

Active Comparator: Monthly injections

3 monthly injections of ranibizumab followed by prn injections

Drug: ranibizumab

3 monthly injections of ranibizumab followed by prn injections for the remainder of the study

Other Names:

Lucentis

Active Comparator: PRN injections

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

Drug: ranibizumab

prn injections of ranibizumab throughout the study

Other Names:

Lucentis

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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