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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Retina Associates of Kentucky.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Retina Associates of Kentucky
ClinicalTrials.gov Identifier:
NCT00955630
First received: August 7, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

Resource links provided by NLM:


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
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

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
  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
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, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Histoplasmosis
Neovascularization, Pathologic
Choroidal Neovascularization
Mycoses
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014