NCT01884597

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2010

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 11, 2017

Completed
Last Updated

October 9, 2017

Status Verified

September 1, 2017

Enrollment Period

3.8 years

First QC Date

June 1, 2012

Results QC Date

March 13, 2017

Last Update Submit

September 8, 2017

Conditions

PCVPolypoidal Choroidal Vasculopathy

Keywords

PEARL2PCVPolypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (2)

  • BCVA

    Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.

    From Baseline to Month 12

  • BCVA

    Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24

    Baseline to M24

Secondary Outcomes (6)

  • Ocular Adverse Events (AE)

    Monthly

  • Systemic AEs

    Monthly

  • BCVA

    at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24

  • Macular Edema

    Baseline, Day 14, Month 1-24

  • PCV Anatomic Changes

    Baseline, Months 6, 12, 24

  • +1 more secondary outcomes

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

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

Drug: high-dose ranibizumabDrug: ranibizumab

Cohort 2

ACTIVE COMPARATOR

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

Drug: high-dose ranibizumabDrug: ranibizumab

Cohort 3

ACTIVE COMPARATOR

24 months of monthly, intravitreal injections of ranibizumab 1.0mg

Drug: ranibizumab

Interventions

high-dose ranibizumabDRUG

20mg ranibizumab vials, 0.05ml injected intravitreally, monthly

Cohort 1Cohort 2
ranibizumabDRUG

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

Also known as: Lucentis
Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age25 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Retina Consultants of Hawaii

Honolulu, Hawaii, 96817, United States

Location

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

The Retina Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Small sample size for each arms group.

Results Point of Contact

Title
Gregg Kokame, MD
Organization
Retina Consultants of Hawaii, Inc.
retinahi@aol.com
(808) 487-8928

Study Officials

  • Gregg T Kokame, MD, MMM

    Hawaii Pacific Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, The Retina Center at Pali Momi

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 24, 2013

Study Start

November 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 9, 2017

Results First Posted

September 11, 2017

Record last verified: 2017-09

Locations

US(3)