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Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Gregg T. Kokame, MD, Hawaii Pacific Health Identifier:
First received: January 18, 2007
Last updated: November 3, 2014
Last verified: November 2014
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: 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 ]
  • Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment [ Time Frame: 1 Year ]

Secondary Outcome Measures:
  • Efficacy as measured by the mean change from baseline in VA at 6 and 12 months [ Time Frame: 1 Year ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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)
Arms Assigned Interventions
Single Arm study

Single arm study:

Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year

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.

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00424710

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, Inc.
Principal Investigator: Gregg T Kokame, MD The Retina Center at Pali Momi
  More Information

Responsible Party: Gregg T. Kokame, MD, Medical Director, The Retina Center at Pali Momi, Hawaii Pacific Health Identifier: NCT00424710     History of Changes
Other Study ID Numbers: FVF3934s
Study First Received: January 18, 2007
Last Updated: November 3, 2014

Keywords provided by Hawaii Pacific Health:
choroidal neovascularization

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 24, 2017