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Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab intravitreal injection
Sponsored by
Hawaii Pacific Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring choroidal neovascularization

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Retina Center at Pali Momi
  • Retina Consultants of Hawaii

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm study

Arm Description

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

Outcomes

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
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment

Secondary Outcome Measures

Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12
Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams
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
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.

Full Information

First Posted
January 18, 2007
Last Updated
November 3, 2014
Sponsor
Hawaii Pacific Health
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00424710
Brief Title
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Acronym
PEARL
Official Title
Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawaii Pacific Health
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy
Keywords
choroidal neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm study
Arm Type
Other
Arm Description
Single arm study: Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Intervention Type
Drug
Intervention Name(s)
ranibizumab intravitreal injection
Intervention Description
liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Primary Outcome Measure Information:
Title
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
Title
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
Time Frame
1 Year
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg T Kokame, MD
Organizational Affiliation
The Retina Center at Pali Momi
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Retina Center at Pali Momi
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Retina Consultants of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19726427
Citation
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.
Results Reference
result

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Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

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