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
Recruitment status was Recruiting
Sponsor:
Retina Associates of Kentucky
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
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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:
MedlinePlus related topics:
Histoplasmosis
Drug Information available for:
Ranibizumab
U.S. FDA Resources
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:
- 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
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
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 May 16, 2013