Status:
COMPLETED
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
Lead Sponsor:
Hawaii Pacific Health
Collaborating Sponsors:
Genentech, Inc.
Conditions:
PCV
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
25-95 years
Phase:
PHASE1
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01884597
Start Date
November 1 2010
End Date
August 1 2014
Last Update
October 9 2017
Active Locations (3)
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1
Retina Consultants of Hawaii
Honolulu, Hawaii, United States, 96817
2
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States, 96701
3
The Retina Center at Pali Momi
‘Aiea, Hawaii, United States, 96701