PEARL - Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

Condition(s) targeted: Polypoidal Choroidal Vasculopathy

Intervention: ranibizumab intravitreal injection (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Hawaii Pacific Health

Official(s) and/or principal investigator(s):
Gregg T Kokame, MD, Principal Investigator, Affiliation: The Retina Center at Pali Momi

Overall contact:
Gregg T Kokame, MD, MMM, Phone: (808) 487-8928, Email: retinahi@aol.com

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

Official title: Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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:

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.

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.

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

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

Gregg T Kokame, MD, MMM, Phone: (808) 487-8928, Email: retinahi@aol.com

The Retina Center at Pali Momi, Aiea, Hawaii 96701, United States; Recruiting
Jacqueline F Shen, Phone: 808-487-8928, Ext: 4838, Email: jshen@retinahi.com
Gregg T Kokame, MD, Principal Investigator

Retina Consultants of Hawaii, Honolulu, Hawaii 96817, United States; Recruiting
Jacqueline F Shen, Phone: 808-487-8928, Ext: 4838, Email: jshen@retinahi.com
Gregg T Kokame, MD, Principal Investigator

Starting date: January 2007
Last updated: March 13, 2007