Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks

Study Overview
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Brief Summary
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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
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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

Official Title
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Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks

Conditions
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Angioid Streaks

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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 Premenopausal women not using adequate contraception. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial History of any previous treatment for angioid streaks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab<br> | Drug: ranibizumab<br>* 0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angioid streaks, CNV, intra vitreal ranibizumab