Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) - Full Text View

Sponsor:	Hawaii Pacific Health
Collaborator:	Genentech
Information provided by:	Hawaii Pacific Health
ClinicalTrials.gov Identifier:	NCT00424710

Purpose

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

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)

Resource links provided by NLM:

Drug Information available for: Ranibizumab

U.S. FDA Resources

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 [ 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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	16
Study Start Date:	January 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year

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
Sub-Investigator: James C Lai, MD

Sponsors and Collaborators

Hawaii Pacific Health

Genentech

Investigators

Principal Investigator:

Gregg T Kokame, MD

The Retina Center at Pali Momi

More Information

No publications provided

Responsible Party:	The Retina Center at Pali MOmi ( Gregg T. Kokame, MD, MMM / Medical Director )
Study ID Numbers:	FVF3934s
Study First Received:	January 18, 2007
Last Updated:	June 1, 2009
ClinicalTrials.gov Identifier:	NCT00424710 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hawaii Pacific Health:

choroidal neovascularization

ClinicalTrials.gov processed this record on November 25, 2009