Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
IVL for OHS
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 7, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedAugust 10, 2009
August 1, 2009
1 year
August 7, 2009
August 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
incidence and severity of ocular adverse events as identified by eye examination
1 year
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
12 mos
Secondary Outcomes (4)
mean change in visual acuity
1 year
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
6 and 12 months
change in fluorescein angiographic outcomes
12 months
mean number of injections
12 mos
Study Arms (2)
Monthly injections
ACTIVE COMPARATOR3 monthly injections of ranibizumab followed by prn injections
PRN injections
ACTIVE COMPARATORinjections of ranibizumab on a prn basis from the start of the study
Interventions
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
Eligibility Criteria
You may qualify if:
- age 18 or over
- active choroidal neovascularization secondary to ocular histoplasmosis
- Visual acuity between 20/25 and 20/400
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Retina Associates of Kentuckylead
- Genentech, Inc.collaborator
Study Sites (1)
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Kitchens, MD
Retina Associates of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2009
First Posted
August 10, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Last Updated
August 10, 2009
Record last verified: 2009-08