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Phase 2 N=24 Treatment

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

PCV · Polypoidal Choroidal Vasculopathy

Enrolled (actual)
24
Serious AEs
4.8%
Results posted
Sep 2017
Primary outcome: Primary: BCVA — -3.50; 29.50; 8.60 number of letters read correctly

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
high-dose ranibizumab (Drug); ranibizumab (Drug)
Age
Adult, Older Adult · 25+ yrs
Sex
All
Sponsor
Hawaii Pacific Health
Primary completion
Aug 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
BCVA
55.00; 50.00; 62.80; 52.00; 52.50; 64.07
PRIMARY
BCVA
55.00; 50.00; 62.80; 52.00; 52.50; 64.07
SECONDARY
Ocular Adverse Events (AE)
0; 0; 0
SECONDARY
Systemic AEs
0; 0; 1
SECONDARY
BCVA
55.00; 50.00; 62.80; 52.00; 52.50; 64.07
SECONDARY
Macular Edema
370.25; 347.50; 282.47; 265.00; 251.00; 235.07
SECONDARY
PCV Anatomic Changes
0; 0; 0; 0; 0; 1
SECONDARY
Fundus Clinical Findings
0; 0; 0; 1; 2; 8

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.

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
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01884597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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