Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Gregg T. Kokame, MD, Hawaii Pacific Health
ClinicalTrials.gov Identifier:
NCT00424710
First received: January 18, 2007
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.


Condition Intervention Phase
Polypoidal Choroidal Vasculopathy
Drug: ranibizumab intravitreal injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)

Resource links provided by NLM:


Further study details as provided by Hawaii Pacific Health:

Primary Outcome Measures:
  • Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy as measured by the mean change from baseline in VA at 6 and 12 months [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Efficacy as proportion of subjects with a decrease in size of the polypoidal vessels from PCV at Mo 6 and 12 as assessed by FA and ICG Angiography [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Efficacy as proportion of subjects with a decrease in macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ranibizumab intravitreal injection
    liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Detailed Description:

Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to provide informed consent and comply with study assessment for the duration of one year
  • Age >= 25 years
  • Polypoidal Choroidal Vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
  • BCVA using ETDRS 20/32 to 20/400

Exclusion Criteria:

  • Any history of previous vitrectomy
  • Previous cataract or ocular surgery within 2 months of day 0
  • Active intraocular inflammation in the study eye
  • Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Participation with another investigational drug within the past 30 days
  • Prior sodium pegaptanib, verteporfin photodynamic therapy, intravitreal steroids, or bevacizumab within 30 days of study entry
  • Blood pressure >180/110 (use of antihypertensives is allowed as long as hypertension can be controlled and is stable)
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424710

Locations
United States, Hawaii
The Retina Center at Pali Momi
Aiea, Hawaii, United States, 96701
Retina Consultants of Hawaii
Honolulu, Hawaii, United States, 96817
Sponsors and Collaborators
Hawaii Pacific Health
Genentech
Investigators
Principal Investigator: Gregg T Kokame, MD The Retina Center at Pali Momi
  More Information

Publications:
Responsible Party: Gregg T. Kokame, MD, Medical Director, The Retina Center at Pali Momi, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT00424710     History of Changes
Other Study ID Numbers: FVF3934s
Study First Received: January 18, 2007
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Hawaii Pacific Health:
choroidal neovascularization

ClinicalTrials.gov processed this record on April 17, 2014