Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

NCT ID: NCT00424710

Last Updated: 2014-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polypoidal Choroidal Vasculopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm study

Single arm study:

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

Group Type OTHER

ranibizumab intravitreal injection

Intervention Type DRUG

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

Interventions

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ranibizumab intravitreal injection

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Hawaii Pacific Health

OTHER

Sponsor Role lead

Responsible Party

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Gregg T. Kokame, MD

Medical Director, The Retina Center at Pali Momi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregg T Kokame, MD

Role: PRINCIPAL_INVESTIGATOR

The Retina Center at Pali Momi

Locations

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Retina Consultants of Hawaii

Honolulu, Hawaii, United States

Site Status

The Retina Center at Pali Momi

‘Aiea, Hawaii, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19726427 (View on PubMed)

Other Identifiers

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FVF3934s

Identifier Type: -

Identifier Source: org_study_id

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