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Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)

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ClinicalTrials.gov Identifier: NCT00424710
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : November 5, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Gregg T. Kokame, MD, Hawaii Pacific Health

Brief Summary:
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 or disease Intervention/treatment Phase
Polypoidal Choroidal Vasculopathy Drug: ranibizumab intravitreal injection Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
Study Start Date : January 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Efficacy as measured by the mean change from baseline in VA at 6 and 12 months [ Time Frame: 1 Year ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.
Investigators
Principal Investigator: Gregg T Kokame, MD The Retina Center at Pali Momi

Publications of Results:
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
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Gregg T. Kokame, MD, Hawaii Pacific Health:
choroidal neovascularization

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents