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

Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively

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.

Study Overview

• Status: Unknown
• Conditions: Polypoidal Choroidal Vasculopathy
• Intervention / Treatment: Drug: ranibizumab 2.0mg

Detailed Description

Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jacqueline F Shen; Phone Number: (808) 380-8060; Email: jshen@retinahi.com

Study Locations

• United States
  • Hawaii
    • Aiea, Hawaii, United States, 96701
      • Recruiting
      • Retina Consultants of Hawaii
      • Contact: Jacqueline F Shen; Phone Number: 808-380-8060; Email: jshen@retinahi.com
      • Principal Investigator: Gregg T Kokame, MD, MMM
      • Sub-Investigator: James C Lai, MD
      • Sub-Investigator: Raymond Wee
    • Honolulu, Hawaii, United States, 96819
      • Recruiting
      • Retina Consultants of Hawaii, Inc
      • Contact: Jacqueline F Shen; Phone Number: 808-380-8060; Email: jshen@retinahi.com
      • Principal Investigator: Gregg T Kokame, MD, MMM
      • Sub-Investigator: James C Lai, MD
      • Sub-Investigator: Raymond Wee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Previously Treated; With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial	Drug: ranibizumab 2.0mg; Monthly, intravitreal injection 0.05ml
Experimental: Treatment-Naive; Treatment-Naive: no previous treatment for PCV	Drug: ranibizumab 2.0mg; Monthly, intravitreal injection 0.05ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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.	1 year
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	1 year

Collaborators and Investigators

• Sponsor: Retina Consultants of Hawaii
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Gregg T Kokame, MD, MMM, Retina Consultants of Hawaii

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: November 24, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (Estimate): November 25, 2010

Study Record Updates

• Last Update Posted (Estimate): November 25, 2010
• Last Update Submitted That Met QC Criteria: November 24, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: PCV; polypoidal; choroidal; vasculopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: FVF4929S