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

Hawaii Pacific Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: PCV; Polypoidal Choroidal Vasculopathy

Treatments: Drug: ranibizumab; Drug: high-dose ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01884597

FVF4929S

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Cohort 1

Active Comparator group

Description:

12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab

Treatment:

Drug: high-dose ranibizumab

Drug: ranibizumab

Cohort 2

Active Comparator group

Description:

6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg

Treatment:

Drug: high-dose ranibizumab

Drug: ranibizumab

Cohort 3

Active Comparator group

Description:

24 months of monthly, intravitreal injections of ranibizumab 1.0mg

Treatment:

Drug: ranibizumab