Clinical trial NCT01871376: Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation
Official title: Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: PCV
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2013-06-06
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV

Detailed description: This is an open-label, randomized, one-year, multiple-dose study of 2mg aflibercept in patients with PCV.

The study consists of the baseline visit on day 0 and a mandatory clinic visit every 30 days to assess efficacy and safety. All patients will receive three monthly injections of 2mg intravitreal aflibercept injection followed by treatment every 60 days through 720 days (24 months). Patients can be treated every 30 days if needed.

The fellow eye may be treated with intravitreal aflibercept injection per the investigator's discretion at any point during the study if evidence of disease activity are met: exudation or hemorrhage secondary to polypoidal choroidal vasculopathy or exudative AMD. The fellow eye will not be considered the study eye. If treatment with aflibercept is to be given in the fellow eye, the injections are to be administered according to the Food and Drug Administration (FDA) approved label for EYLEA®.

Eligibility criteria: Inclusion Criteria:

* Age \> 25 years of age.
* In the opinion of the principal investigator, the study eye has PCV with active exudation and/or bleeding that may benefit from treatment with study medication.
* Diagnosis of PCV via ICG Angiography with evidence of active leakage, active bleeding or recent decreased in vision.
* Baseline visual acuity better than or equal to 20/200 using ETDRS
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent

Exclusion Criteria:

* Any history of previous vitrectomy
* Previous cataract surgery within the preceding 2 months of Day 0
* Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Presence of any condition that would jeopardize the patient's participation in this study
* 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
* For the Treatment-Naïve cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis, Eylea) in the study eye
* For the Previous-Treated cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days or enrollment in this study
* For the Previous-Treated cohort: no prior Eylea in the study eye
* Known allergy to any component of the study drug
* Blood pressure \>180/119 (systolic above 180 or diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the patient can be 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 infarction, 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
* Pregnant or breast-feeding women
* Simultaneous participation in another medical investigational trial
* Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

Primary outcomes:
measure: efficacy of intravitreal aflibercept injection of 2.0mg aflibercept
timeFrame: 2 Years
Secondary outcomes:
measure: Proportion of Patients with Stable, Improved, Significant Improved, Decreased, Significant Decreased Vision
timeFrame: 6 Months, 12 Months, 18 Months, 24 Months
measure: Proportion of Patients with decrease in Subretinal Hemorrhage and/or Exudates
timeFrame: Month 6, Month 12, Month 18, Month 24
measure: Proportion of patients with decreased / complete resolution of Polypoidal Polyp.
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Proportion of subject with a decrease or complete resolution of branching vascular network from PCV
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Determine mean change in Central Foveal Thickness and/or peripapillary edema as measured by SD-OCT
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24
measure: Mean Change in Choroidal Thickness
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24
measure: Proportion of previously treated and treatment naive patients that require additional dosing outside of the protocol determined dosing schedule
timeFrame: Month 24
measure: Assess changes on Autofluorescence
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24
measure: Incidence and Severity of Ocular and Non-Ocular Adverse Events
timeFrame: Baseline through Month 24
Other outcomes:
Locations:
city: Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
Study officials:
affiliation: Hawaii Pacific Health
name: Gregg T. Kokame, MD, MMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kokame GT, Lai JC, Wee R, Yanagihara R, Shantha JG, Ayabe J, Hirai K. Prospective clinical trial of Intravitreal aflibercept treatment for PolypoIdal choroidal vasculopathy with hemorrhage or exudation (EPIC study): 6 month results. BMC Ophthalmol. 2016 Jul 27;16:127. doi: 10.1186/s12886-016-0305-2.