Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

Polypoidal Choroidal Vasculopathy Clinical Trial

— PEARL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424710
• Other study ID #: FVF3934s
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2007
• Last updated: November 3, 2014
• Start date: January 2007
• Est. completion date: September 2010

Study information

• Verified date: November 2014
• Source: Hawaii Pacific Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	The Retina Center at Pali Momi	Aiea	Hawaii
United States	Retina Consultants of Hawaii	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Hawaii Pacific Health	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline		1 year	No
Primary	Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment		1 Year	Yes
Secondary	Efficacy as measured by the mean change from baseline in VA at 6 and 12 months		1 Year	No
Secondary	Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12		1 Year	No
Secondary	Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams		1 Year	No
Secondary	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		1 Year	No
Secondary	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.		1 Year	No