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Trial record 1 of 36 for:    retina associates of kentucky
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Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome (IVL for OHS)

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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:
Genentech, Inc.
Information provided by:
Retina Associates of Kentucky

Tracking Information
First Submitted Date  ICMJE August 7, 2009
First Posted Date  ICMJE August 10, 2009
Last Update Posted Date August 10, 2009
Study Start Date  ICMJE August 2009
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
  • incidence and severity of ocular adverse events as identified by eye examination [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
  • mean change in visual acuity [ Time Frame: 1 year ]
  • mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography [ Time Frame: 6 and 12 months ]
  • change in fluorescein angiographic outcomes [ Time Frame: 12 months ]
  • mean number of injections [ Time Frame: 12 mos ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Official Title  ICMJE Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
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:

  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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ocular Histoplasmosis Syndrome
Intervention  ICMJE
  • Drug: ranibizumab
    3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
    Other Name: Lucentis
  • Drug: ranibizumab
    prn injections of ranibizumab throughout the study
    Other Name: Lucentis
Study Arms  ICMJE
  • Active Comparator: Monthly injections
    3 monthly injections of ranibizumab followed by prn injections
    Intervention: Drug: ranibizumab
  • Active Comparator: PRN injections
    injections of ranibizumab on a prn basis from the start of the study
    Intervention: Drug: ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 7, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00955630
Other Study ID Numbers  ICMJE FVF 4147S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. John Kitchens, Md/Principal Investigator, Retina Associates of Kentucky
Study Sponsor  ICMJE Retina Associates of Kentucky
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: John Kitchens, MD Retina Associates of Kentucky
PRS Account Retina Associates of Kentucky
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP