Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome - Full Text View

Sponsors and Collaborators:	Retina Associates of Kentucky Genentech
Information provided by:	Retina Associates of Kentucky
ClinicalTrials.gov Identifier:	NCT00955630

Purpose

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	Intervention	Phase
Ocular Histoplasmosis Syndrome	Drug: ranibizumab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

Resource links provided by NLM:

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Retina Associates of Kentucky:

Primary Outcome Measures:

incidence and severity of ocular adverse events as identified by eye examination [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs [ Time Frame: 12 mos ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

mean change in visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
change in fluorescein angiographic outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
mean number of injections [ Time Frame: 12 mos ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2009
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Monthly injections: Active Comparator 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
PRN injections: Active Comparator injections of ranibizumab on a prn basis from the start of the study	Drug: ranibizumab prn injections of ranibizumab throughout the study

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955630

Contacts

Contact: Diana Holcomb, COA	859-263-3900 ext 145	dholcomb@retinaky.com
Contact: Wanda Heath, BS, COT, CCRC	859-263-3900 ext 106	wheath@retinaky.com

Locations

United States, Kentucky
Retina Associates of Kentucky	Recruiting
Lexington, Kentucky, United States, 40509
Principal Investigator: John Kitchens, MD
Sub-Investigator: Tom Stone, MD
Sub-Investigator: William J Wood, MD
Sub-Investigator: Rick D Isernhagen, MD

Sponsors and Collaborators

Retina Associates of Kentucky

Genentech

Investigators

Principal Investigator:

John Kitchens, MD

Retina Associates of Kentucky

More Information

No publications provided

Responsible Party:	Retina Associates of Kentucky ( Dr. John Kitchens, Md/Principal Investigator )
Study ID Numbers:	FVF 4147S
Study First Received:	August 7, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955630 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Retina Associates of Kentucky:

Histoplasmosis
Lucentis
Ranibizumab
OHS

Study placed in the following topic categories:

Mycoses
Uveal Diseases
Eye Diseases
Metaplasia

Choroid Diseases
Histoplasmosis
Neovascularization, Pathologic
Choroidal Neovascularization

Additional relevant MeSH terms:

Mycoses
Uveal Diseases
Disease
Pathologic Processes
Eye Diseases
Metaplasia

Syndrome
Choroid Diseases
Histoplasmosis
Neovascularization, Pathologic
Choroidal Neovascularization

ClinicalTrials.gov processed this record on September 11, 2009