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

NCT ID: NCT01015495

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-01-31

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

Conditions

Angioid Streaks

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ranibizumab

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

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

Interventions

ranibizumab

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

Intervention Type: DRUG

Other Intervention Names

Lucentis

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Jennifer I. Lim

Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer I Lim, MD

Role: PRINCIPAL_INVESTIGATOR

UIC Eye and Ear Infirmary

Related Links

http://www.uic.edu/com/eye/

UIC-Ophthalmology home page

Other Identifiers

fvf 3763s

Identifier Type: -

Identifier Source: org_study_id