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

Phase 1

Withdrawn

• Conditions: Angioid Streaks
• Interventions: Drug: ranibizumab

• Registration Number: NCT01015495
• Lead Sponsor: University of Illinois at Chicago

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

Study Timeline

• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Study Start: 2009-12
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ranibizumab	ranibizumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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