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

Ocular Histoplasmosis Syndrome Clinical Trial

— IVL for OHS  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00955630
• Other study ID #: FVF 4147S
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: August 7, 2009
• Last updated: August 7, 2009
• Start date: August 2009

Study information

• Verified date: August 2009
• Source: Retina Associates of Kentucky
• Contact: Diana Holcomb, COA
• Phone: 859-263-3900
• Email: dholcomb[@]retinaky.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Histoplasmosis
• Neovascularization, Pathologic
• Ocular Histoplasmosis Syndrome
• Syndrome

Intervention

Drug:
• ranibizumab
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
• ranibizumab
prn injections of ranibizumab throughout the study

Locations

Country	Name	City	State
United States	Retina Associates of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Retina Associates of Kentucky	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of ocular adverse events as identified by eye examination		1 year
Primary	incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs		12 mos
Secondary	mean change in visual acuity		1 year
Secondary	mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography		6 and 12 months
Secondary	change in fluorescein angiographic outcomes		12 months
Secondary	mean number of injections		12 mos