Clinical Trial: Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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 Summary:
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
Sponsor: Retina Associates of Kentucky
Current Primary Outcome:
- 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: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Retina Associates of Kentucky
Dates:
Date Received: August 7, 2009
Date Started: August 2009
Date Completion:
Last Updated: August 7, 2009
Last Verified: August 2009
