Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
Overview
- Phase
- Phase 1
- Intervention
- ranibizumab
- Conditions
- Angioid Streaks
- Sponsor
- University of Illinois at Chicago
- Primary Endpoint
- The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.
Detailed Description
Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks
Investigators
Jennifer I. Lim
Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age \> 18 years
- •Angioid streaks
- •Subfoveal CNV of recent onset with the following characteristics
- •Absence of subfoveal fibrosis
- •Fibrosis less than 25% of the lesion
- •Presence of blood, subretinal fluid, and/or lipid
- •New onset symptoms within 12 weeks
- •Visual acuity 20/40 to 20/800 on an ETDRS chart
Exclusion Criteria
- •Prior treatment of subfoveal CNV in the study eye
- •Age-related macular degeneration
- •Uncontrolled glaucoma
- •High myopia (\> -10.00 D spherical equivalent)
- •Prior retinal detachment
- •Media opacity preventing adequate view of the retina
- •Planned cataract surgery in the next 3 months
- •Current chemotherapy for cancer
- •Immunocompromised state
- •Pregnancy (positive pregnancy test) or lactation
Arms & Interventions
ranibizumab
Intervention: ranibizumab
Outcomes
Primary Outcomes
The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Time Frame: Month 12
Secondary Outcomes
- Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12(Month 6 and 12)