We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00955630
Recruitment Status : Unknown
Verified August 2009 by Retina Associates of Kentucky.
Recruitment status was:  Recruiting
First Posted : August 10, 2009
Last Update Posted : August 10, 2009
Sponsor:
Collaborator:
Information provided by:

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 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:

  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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2009
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

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 Name: 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 Name: Lucentis


Outcome Measures

Primary Outcome Measures :
  1. incidence and severity of ocular adverse events as identified by eye examination [ Time Frame: 1 year ]
  2. 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 Measures :
  1. mean change in visual acuity [ Time Frame: 1 year ]
  2. mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography [ Time Frame: 6 and 12 months ]
  3. change in fluorescein angiographic outcomes [ Time Frame: 12 months ]
  4. mean number of injections [ Time Frame: 12 mos ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.
Investigators
Principal Investigator: John Kitchens, MD Retina Associates of Kentucky
More Information

Responsible Party: Dr. John Kitchens, Md/Principal Investigator, Retina Associates of Kentucky
ClinicalTrials.gov Identifier: NCT00955630     History of Changes
Other Study ID Numbers: FVF 4147S
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: August 2009

Keywords provided by Retina Associates of Kentucky:
Histoplasmosis
Lucentis
Ranibizumab
OHS

Additional relevant MeSH terms:
Syndrome
Neovascularization, Pathologic
Choroidal Neovascularization
Histoplasmosis
Disease
Pathologic Processes
Metaplasia
Choroid Diseases
Uveal Diseases
Eye Diseases
Mycoses
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents