Clinical trial NCT01884597: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
Official title: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: PCV
Polypoidal Choroidal Vasculopathy
Keywords: PEARL2
PCV
Polypoidal Choroidal Vasculopathy
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-06-24
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: BCVA
timeFrame: From Baseline to Month 12
measure: BCVA
timeFrame: Baseline to M24
Secondary outcomes:
measure: Ocular Adverse Events (AE)
timeFrame: Monthly
measure: Systemic AEs
timeFrame: Monthly
measure: BCVA
timeFrame: at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
measure: Macular Edema
timeFrame: Baseline, Day 14, Month 1-24
measure: PCV Anatomic Changes
timeFrame: Baseline, Months 6, 12, 24
measure: Fundus Clinical Findings
timeFrame: Baseline, Months 6, 12, 24
Other outcomes:
Locations:
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: 'Aiea
country: United States
facility: The Retina Center at Pali Momi
state: Hawaii
city: Honolulu
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
Study officials:
affiliation: Hawaii Pacific Health
name: Gregg T Kokame, MD, MMM
role: PRINCIPAL_INVESTIGATOR
References: