Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
Primary Purpose
Angioid Streaks
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Angioid Streaks focused on measuring angioid streaks, CNV, intra vitreal ranibizumab
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ranibizumab
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01015495
First Posted
November 17, 2009
Last Updated
June 28, 2012
Sponsor
University of Illinois at Chicago
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01015495
Brief Title
Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
Official Title
Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough patients within the time frame to allow for a meaningful study.
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioid Streaks
Keywords
angioid streaks, CNV, intra vitreal ranibizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Time Frame
Month 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer I Lim, MD
Organizational Affiliation
UIC Eye and Ear Infirmary
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.uic.edu/com/eye/
Description
UIC-Ophthalmology home page
Learn more about this trial
Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
We'll reach out to this number within 24 hrs