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Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)

NCT ID: NCT01884597

Last Updated: 2017-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-08-31

Brief Summary

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This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.

Detailed Description

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Conditions

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PCV Polypoidal Choroidal Vasculopathy

Keywords

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PEARL2 PCV Polypoidal Choroidal Vasculopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab

Group Type ACTIVE_COMPARATOR

high-dose ranibizumab

Intervention Type DRUG

20mg ranibizumab vials, 0.05ml injected intravitreally, monthly

ranibizumab

Intervention Type DRUG

3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly

Cohort 2

6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg

Group Type ACTIVE_COMPARATOR

high-dose ranibizumab

Intervention Type DRUG

20mg ranibizumab vials, 0.05ml injected intravitreally, monthly

ranibizumab

Intervention Type DRUG

3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly

Cohort 3

24 months of monthly, intravitreal injections of ranibizumab 1.0mg

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly

Interventions

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high-dose ranibizumab

20mg ranibizumab vials, 0.05ml injected intravitreally, monthly

Intervention Type DRUG

ranibizumab

3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* 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 of 20/32 to 20/400

Exclusion Criteria

* Any history of previous vitrectomy
* Any prior treatment with verteporfin photodynamic therapy in the study eye.
* Previous cataract surgery within the preceding 2 months of Day 0
* Active intraocular inflammation in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease)
* Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
* Prior anti-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in the study eye prior within 30 days prior to enrollment in this study
* Known allergy to any component of the study drug
* Blood pressure \>180/110 (systolic above 180 or diastolic above 110) If blood pressure if brought below 180/110 by anti-hypertensive treatment, the patient can become eligible.
* Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
* Myocardial infraction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
* Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
* History of recurrent significant infections or bacterial infections
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception, surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicide gel, an intra uterine device (IUD), or contraceptive hormone implant or patch
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial.
Minimum Eligible Age

25 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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, MMM

Role: PRINCIPAL_INVESTIGATOR

Hawaii Pacific Health

Locations

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Retina Consultants of Hawaii

Honolulu, Hawaii, United States

Site Status

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

The Retina Center at Pali Momi

‘Aiea, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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FVF4929S

Identifier Type: -

Identifier Source: org_study_id