Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
This study has been withdrawn prior to enrollment.
(Not enough patients within the time frame to allow for a meaningful study.)
Sponsor:
University of Illinois
Collaborator:
Genentech
Information provided by (Responsible Party):
Jennifer I. Lim, University of Illinois
ClinicalTrials.gov Identifier:
NCT01015495
First received: November 17, 2009
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Angioid Streaks |
Drug: ranibizumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks |
Resource links provided by NLM:
Further study details as provided by University of Illinois:
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) [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | December 2009 |
| Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ranibizumab |
Drug: 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
Other Name: Lucentis
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Jennifer I. Lim, Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences, University of Illinois |
| ClinicalTrials.gov Identifier: | NCT01015495 History of Changes |
| Other Study ID Numbers: | fvf 3763s |
| Study First Received: | November 17, 2009 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Illinois:
|
angioid streaks CNV intra vitreal ranibizumab |
Additional relevant MeSH terms:
|
Angioid Streaks Neovascularization, Pathologic Choroidal Neovascularization Retinal Diseases Eye Diseases |
Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013