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

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ClinicalTrials.gov Identifier: NCT01884597
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : September 11, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Gregg T. Kokame, MD, Hawaii Pacific Health

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.

Condition or disease Intervention/treatment Phase
PCV Polypoidal Choroidal Vasculopathy Drug: high-dose ranibizumab Drug: ranibizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively
Study Start Date : November 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: Cohort 1
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
Drug: high-dose ranibizumab
20mg ranibizumab vials, 0.05ml injected intravitreally, monthly

Drug: ranibizumab
3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
Other Name: Lucentis

Active Comparator: Cohort 2
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 ranibizumab
20mg ranibizumab vials, 0.05ml injected intravitreally, monthly

Drug: ranibizumab
3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
Other Name: Lucentis

Active Comparator: Cohort 3
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
Drug: ranibizumab
3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
Other Name: Lucentis




Primary Outcome Measures :
  1. BCVA [ Time Frame: From Baseline to Month 12 ]
    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.

  2. BCVA [ Time Frame: Baseline to M24 ]
    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


Secondary Outcome Measures :
  1. Ocular Adverse Events (AE) [ Time Frame: Monthly ]
    Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)

  2. Systemic AEs [ Time Frame: Monthly ]
    Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

  3. BCVA [ Time Frame: at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 ]
    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, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24

  4. Macular Edema [ Time Frame: Baseline, Day 14, Month 1-24 ]
    Optical Coherence Tomography (OCT) central macular and peripapillary thickness

  5. PCV Anatomic Changes [ Time Frame: Baseline, Months 6, 12, 24 ]

    Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography

    Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography


  6. Fundus Clinical Findings [ Time Frame: Baseline, Months 6, 12, 24 ]
    Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884597


Locations
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United States, Hawaii
Retina Consultants of Hawaii
'Aiea, Hawaii, United States, 96701
The Retina Center at Pali Momi
'Aiea, Hawaii, United States, 96701
Retina Consultants of Hawaii
Honolulu, Hawaii, United States, 96817
Sponsors and Collaborators
Hawaii Pacific Health
Genentech, Inc.
Investigators
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Principal Investigator: Gregg T Kokame, MD, MMM Hawaii Pacific Health

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Responsible Party: Gregg T. Kokame, MD, Medical Director, The Retina Center at Pali Momi, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT01884597     History of Changes
Other Study ID Numbers: FVF4929S
First Posted: June 24, 2013    Key Record Dates
Results First Posted: September 11, 2017
Last Update Posted: October 9, 2017
Last Verified: September 2017

Keywords provided by Gregg T. Kokame, MD, Hawaii Pacific Health:
PEARL2
PCV
Polypoidal Choroidal Vasculopathy

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents