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

August 7, 2009 updated by: Retina Associates of Kentucky
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: ranibizumab
prn injections of ranibizumab throughout the study
Other Names:
  • Lucentis
Active Comparator: PRN injections
injections of ranibizumab on a prn basis from the start of the study
Drug: ranibizumab
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
Other Names:
  • Lucentis
Drug: ranibizumab
prn injections of ranibizumab throughout the study
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Associates of Kentucky

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: John Kitchens, MD, Retina Associates of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 10, 2009

Last Update Submitted That Met QC Criteria

August 7, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF 4147S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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