investigator sponsored trial of polypoidal choroidal vasculopathy (pcv) evaluation assessing high-dose ranibizumab prospectively (pearl2)

Conditions: PCV; Polypoidal Choroidal Vasculopathy

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.

Keywords: pearl2 pcv polypoidal choroidal vasculopathy