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PEARL - Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

This study is currently recruiting participants.
Verified by Hawaii Pacific Health, March 2007

Sponsored by: Hawaii Pacific Health
Information provided by: Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT00424710
  Purpose

12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by FA/ICG angiography.


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

ChemIDplus related topics:   Ranibizumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)

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
  • Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment

Secondary Outcome Measures:
  • Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
  • Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12
  • Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams
  • 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
  • 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.

Estimated Enrollment:   12
Study Start Date:   January 2007

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

Contacts
Contact: Gregg T Kokame, MD, MMM     (808) 487-8928     retinahi@aol.com    
Contact: Jacqueline F Shen     (808) 487-8928 ext 4838     jshen@retinahi.com    

Locations
United States, Hawaii
The Retina Center at Pali Momi     Recruiting
      Aiea, Hawaii, United States, 96701
      Contact: Jacqueline F Shen     808-487-8928 ext 4838     jshen@retinahi.com    
      Principal Investigator: Gregg T Kokame, MD            
Retina Consultants of Hawaii     Recruiting
      Honolulu, Hawaii, United States, 96817
      Contact: Jacqueline F Shen     808-487-8928 ext 4838     jshen@retinahi.com    
      Principal Investigator: Gregg T Kokame, MD            

Sponsors and Collaborators
Hawaii Pacific Health

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


Study ID Numbers:   FVF3934s
First Received:   January 18, 2007
Last Updated:   March 13, 2007
ClinicalTrials.gov Identifier:   NCT00424710
Health Authority:   United States: Food and Drug Administration

Keywords provided by Hawaii Pacific Health:
choroidal neovascularization  

Study placed in the following topic categories:
Neovascularization, Pathologic
Choroidal Neovascularization

ClinicalTrials.gov processed this record on October 03, 2008




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