Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.
Sponsor
Ophthalmic Consultants of Boston (Other)
Overall Status
Completed
CT.gov ID
NCT00395551
Collaborator
Genentech, Inc. (Industry)
30
1
42
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Center Study of the Safety and Efficacy of Multiple Intravitreal Injections of Ranibizumab in Subjects With CNV Secondary to Causes Other Than AMD.
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ranibizumab ranibizumab 0.5mg intravitreal injection |
Drug: ranibizumab
0.5mg intravitreal injection
|
Outcome Measures
Primary Outcome Measures
- The primary outcome measures for safety and tolerability [Mean change in visual acuity from baseline to 6 months & 12 months]
Secondary Outcome Measures
- The secondary outcome measures for efficacy [Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- active choroidal neovascularization
Exclusion Criteria:
- pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ophthalmic Consultants of Boston
- Genentech, Inc.
Investigators
- Principal Investigator: Jeffrey S Heier, M.D., Ophthalmic Consultants of Boston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00395551
Other Study ID Numbers:
- FVF 3688 Non-AMD
First Posted:
Nov 3, 2006
Last Update Posted:
Jan 8, 2010
Last Verified:
Jan 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms: