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

Primary Purpose

Ocular Histoplasmosis Syndrome

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
ranibizumab
Sponsored by
Retina Associates of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Histoplasmosis Syndrome focused on measuring Histoplasmosis, Lucentis, Ranibizumab, OHS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Retina Associates of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Monthly injections

PRN injections

Arm Description

3 monthly injections of ranibizumab followed by prn injections

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

Outcomes

Primary Outcome Measures

incidence and severity of ocular adverse events as identified by eye examination
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs

Secondary Outcome Measures

mean change in visual acuity
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
change in fluorescein angiographic outcomes
mean number of injections

Full Information

First Posted
August 7, 2009
Last Updated
August 7, 2009
Sponsor
Retina Associates of Kentucky
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00955630
Brief Title
Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Acronym
IVL for OHS
Official Title
Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Retina Associates of Kentucky
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Histoplasmosis Syndrome
Keywords
Histoplasmosis, Lucentis, Ranibizumab, OHS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monthly injections
Arm Type
Active Comparator
Arm Description
3 monthly injections of ranibizumab followed by prn injections
Arm Title
PRN injections
Arm Type
Active Comparator
Arm Description
injections of ranibizumab on a prn basis from the start of the study
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
prn injections of ranibizumab throughout the study
Primary Outcome Measure Information:
Title
incidence and severity of ocular adverse events as identified by eye examination
Time Frame
1 year
Title
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
Time Frame
12 mos
Secondary Outcome Measure Information:
Title
mean change in visual acuity
Time Frame
1 year
Title
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
Time Frame
6 and 12 months
Title
change in fluorescein angiographic outcomes
Time Frame
12 months
Title
mean number of injections
Time Frame
12 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Holcomb, COA
Phone
859-263-3900
Ext
145
Email
dholcomb@retinaky.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wanda Heath, BS, COT, CCRC
Phone
859-263-3900
Ext
106
Email
wheath@retinaky.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kitchens, MD
Organizational Affiliation
Retina Associates of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kitchens, MD
First Name & Middle Initial & Last Name & Degree
Tom Stone, MD
First Name & Middle Initial & Last Name & Degree
William J Wood, MD
First Name & Middle Initial & Last Name & Degree
Rick D Isernhagen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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