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

Polypoidal Choroidal Vasculopathy Clinical Trial

— PEARL2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884597
• Other study ID #: FVF4929S
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 1, 2012
• Last updated: September 8, 2017
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2017
• Source: Hawaii Pacific Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• PCV
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• high-dose ranibizumab
20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
• ranibizumab
3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly

Locations

Country	Name	City	State
United States	Retina Consultants of Hawaii	'Aiea	Hawaii
United States	The Retina Center at Pali Momi	'Aiea	Hawaii
United States	Retina Consultants of Hawaii	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Hawaii Pacific Health	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.	From Baseline to Month 12
Primary	BCVA	Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24	Baseline to M24
Secondary	Ocular Adverse Events (AE)	Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)	Monthly
Secondary	Systemic AEs	Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs	Monthly
Secondary	BCVA	Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24	at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Secondary	Macular Edema	Optical Coherence Tomography (OCT) central macular and peripapillary thickness	Baseline, Day 14, Month 1-24
Secondary	PCV Anatomic Changes	Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography; Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography	Baseline, Months 6, 12, 24
Secondary	Fundus Clinical Findings	Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam	Baseline, Months 6, 12, 24