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

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 Treated
    With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial
  • Experimental: Treatment-Naive
    Treatment-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

Locations (2)

FacilityCityStateZIPSite coordinators
Retina Consultants of Hawaii‘AieaHawaii96701
Jacqueline F Shen
808-380-8060
Gregg T Kokame, MD, MMM (PRINCIPAL_INVESTIGATOR)
James C Lai, MD (SUB_INVESTIGATOR)
Raymond Wee (SUB_INVESTIGATOR)
Retina Consultants of Hawaii, IncHonoluluHawaii96819
Jacqueline F Shen
808-380-8060
Gregg T Kokame, MD, MMM (PRINCIPAL_INVESTIGATOR)
James C Lai, MD (SUB_INVESTIGATOR)
Raymond Wee, MD (SUB_INVESTIGATOR)

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