Full Text View
Tabular View
No Study Results Posted
Related Studies
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)
This study is currently recruiting participants.
Study NCT00424710   Information provided by Hawaii Pacific Health
First Received: January 18, 2007   Last Updated: June 1, 2009   History of Changes

January 18, 2007
June 1, 2009
January 2007
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • 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
Complete list of historical versions of study NCT00424710 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
 
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)

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.

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.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Polypoidal Choroidal Vasculopathy
Drug: ranibizumab intravitreal injection
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
16
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
25 Years and older
Yes
Contact: Gregg T Kokame, MD, MMM (808) 487-8928 retinahi@aol.com
Contact: Jacqueline F Shen (808) 487-8928 ext 4838 jshen@retinahi.com
United States
 
NCT00424710
Gregg T. Kokame, MD, MMM / Medical Director, The Retina Center at Pali MOmi
FVF3934s
Hawaii Pacific Health
Genentech
Principal Investigator: Gregg T Kokame, MD The Retina Center at Pali Momi
Hawaii Pacific Health
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP