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Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy (PEARL2)

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab 2.0mg
Sponsored by
Retina Consultants of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring PCV, polypoidal, choroidal, vasculopathy

Eligibility Criteria

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

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
  • BVCA using ETDRS of 20/32 to 20/400

Exclusion Criteria:

  • Any history of prior vitrectomy
  • Any prior treatment with verteporfin PDT in the study eye
  • Previous cataract surgery within the preceding 2 months of D0
  • 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 another 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-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study
  • Known allergy to any component in the study drug
  • Uncontrolled hypertension: >180/110
  • major surgery within 28 days prior to randomization
  • Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization
  • Systemic anti-VEGF or pro-VEGF within 3 months of randomization
  • Pregnancy or lactation
  • History of recurrent significant infections or bacterial infections

Sites / Locations

  • Retina Consultants of HawaiiRecruiting
  • Retina Consultants of Hawaii, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Previously Treated

Treatment-Naive

Arm Description

With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial

Treatment-Naive: no previous treatment for PCV

Outcomes

Primary Outcome Measures

To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12

Secondary Outcome Measures

To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12.
To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV
the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs

Full Information

First Posted
November 24, 2010
Last Updated
November 24, 2010
Sponsor
Retina Consultants of Hawaii
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01248117
Brief Title
Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
Acronym
PEARL2
Official Title
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Retina Consultants of Hawaii
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Detailed Description
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Previously Treated
Arm Type
Experimental
Arm Description
With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial
Arm Title
Treatment-Naive
Arm Type
Experimental
Arm Description
Treatment-Naive: no previous treatment for PCV
Intervention Type
Drug
Intervention Name(s)
ranibizumab 2.0mg
Intervention Description
Monthly, intravitreal injection 0.05ml
Primary Outcome Measure Information:
Title
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
Description
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
Description
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
Time Frame
1 year
Title
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss
Description
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12.
Time Frame
1 year
Title
To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV
Description
the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs
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 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 BVCA using ETDRS of 20/32 to 20/400 Exclusion Criteria: Any history of prior vitrectomy Any prior treatment with verteporfin PDT in the study eye Previous cataract surgery within the preceding 2 months of D0 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 another 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-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study Known allergy to any component in the study drug Uncontrolled hypertension: >180/110 major surgery within 28 days prior to randomization Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization Systemic anti-VEGF or pro-VEGF within 3 months of randomization Pregnancy or lactation History of recurrent significant infections or bacterial infections
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline F Shen
Phone
(808) 380-8060
Email
jshen@retinahi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg T Kokame, MD, MMM
Organizational Affiliation
Retina Consultants of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Consultants of Hawaii
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline F Shen
Phone
808-380-8060
Email
jshen@retinahi.com
First Name & Middle Initial & Last Name & Degree
Gregg T Kokame, MD, MMM
First Name & Middle Initial & Last Name & Degree
James C Lai, MD
First Name & Middle Initial & Last Name & Degree
Raymond Wee
Facility Name
Retina Consultants of Hawaii, Inc
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline F Shen
Phone
808-380-8060
Email
jshen@retinahi.com
First Name & Middle Initial & Last Name & Degree
Gregg T Kokame, MD, MMM
First Name & Middle Initial & Last Name & Degree
James C Lai, MD
First Name & Middle Initial & Last Name & Degree
Raymond Wee, MD

12. IPD Sharing Statement

Learn more about this trial

Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

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