Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
Part of paid clinical trials in ‘Aiea, Hawaii.
- Sponsor
- Retina Consultants of Hawaii
- Study ID
- NCT01248117
- Phase
- PHASE1/PHASE2
- Status
- Unknown
Conditions
- Polypoidal Choroidal Vasculopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 25 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- ranibizumab 2.0mg — DRUGMonthly, intravitreal injection 0.05ml
Study Details
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Key Dates
- First listed
- Nov 25, 2010
- Start date
- Nov 30, 2010
- Status verified
- Nov 2010
- Primary completion
- Dec 31, 2012
- Completion
- Feb 28, 2013
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Previously TreatedWith prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial
- Experimental: Treatment-NaiveTreatment-Naive: no previous treatment for PCV
Primary Outcome Measure
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss [ Time Frame: 1 year ]
Central Contacts
- Jacqueline F Shen(808) 380-8060
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | Gregg T Kokame, MD, MMM (PRINCIPAL_INVESTIGATOR) James C Lai, MD (SUB_INVESTIGATOR) Raymond Wee (SUB_INVESTIGATOR) |
| Retina Consultants of Hawaii, Inc | Honolulu | Hawaii | 96819 | Gregg T Kokame, MD, MMM (PRINCIPAL_INVESTIGATOR) James C Lai, MD (SUB_INVESTIGATOR) Raymond Wee, MD (SUB_INVESTIGATOR) |
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