Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)

November 3, 2014 updated by: Gregg T. Kokame, MD, Hawaii Pacific Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Aiea, Hawaii, United States, 96701
        • The Retina Center at Pali Momi
      • Honolulu, Hawaii, United States, 96817
        • Retina Consultants of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm study

Single arm study:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
Time Frame: 1 Year
1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
Time Frame: 1 Year
1 Year
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
1 Year
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
1 Year
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
1 Year
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
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawaii Pacific Health

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Gregg T Kokame, MD, The Retina Center at Pali Momi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 18, 2007

First Submitted That Met QC Criteria

January 18, 2007

First Posted (Estimate)

January 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF3934s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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