Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)

Part of paid clinical trials in ‘Aiea, Hawaii.

Sponsor
Hawaii Pacific Health
Study ID
NCT01884597
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • PCV
  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
25 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • high-dose ranibizumab — DRUG
    20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
  • ranibizumab — DRUG
    3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly

Study Details

This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.

Key Dates

First listed
Jun 24, 2013
Start date
Nov 30, 2010
Status verified
Sep 2017
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1
    12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
  • Active Comparator: Cohort 2
    6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
  • Active Comparator: Cohort 3
    24 months of monthly, intravitreal injections of ranibizumab 1.0mg

Primary Outcome Measure

BCVA [ Time Frame: From Baseline to Month 12 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Retina Consultants of Hawaii‘AieaHawaii96701-
The Retina Center at Pali Momi‘AieaHawaii96701-
Retina Consultants of HawaiiHonoluluHawaii96817-

Find similar trials in ‘Aiea, HI

By research site
Retina Consultants of Hawaii· ‘Aiea, HIThe Retina Center at Pali Momi· ‘Aiea, HIRetina Consultants of Hawaii· Honolulu, HI

Related Studies