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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Retina Consultants of Hawaii.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Retina Consultants of Hawaii
ClinicalTrials.gov Identifier:
NCT01248117
First received: November 24, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Polypoidal Choroidal Vasculopathy
Drug: ranibizumab 2.0mg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively

Resource links provided by NLM:


Further study details as provided by Retina Consultants of Hawaii:

Primary Outcome Measures:
  • To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248117

Contacts
Contact: Jacqueline F Shen (808) 380-8060 jshen@retinahi.com

Locations
United States, Hawaii
Retina Consultants of Hawaii Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jacqueline F Shen    808-380-8060    jshen@retinahi.com   
Principal Investigator: Gregg T Kokame, MD, MMM         
Sub-Investigator: James C Lai, MD         
Sub-Investigator: Raymond Wee         
Retina Consultants of Hawaii, Inc Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Jacqueline F Shen    808-380-8060    jshen@retinahi.com   
Principal Investigator: Gregg T Kokame, MD, MMM         
Sub-Investigator: James C Lai, MD         
Sub-Investigator: Raymond Wee, MD         
Sponsors and Collaborators
Retina Consultants of Hawaii
Genentech
Investigators
Principal Investigator: Gregg T Kokame, MD, MMM Retina Consultants of Hawaii
  More Information

No publications provided

Responsible Party: Gregg T. Kokame / Managing Partner, Retina Consultants of Hawaii
ClinicalTrials.gov Identifier: NCT01248117     History of Changes
Other Study ID Numbers: FVF4929s
Study First Received: November 24, 2010
Last Updated: November 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Consultants of Hawaii:
PCV
polypoidal
choroidal
vasculopathy

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014