Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

NCT ID: NCT01871376

Last Updated: 2016-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-09-30

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®.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

PCV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Previously Treated

Patients that have previously received treatment for polypoidal choroidal vasculopathy.

Intervention: Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for previously treated arm.

Group Type: ACTIVE_COMPARATOR

Intravitreal aflibercept injection 2.0mg

Intervention Type: DRUG

Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms.

Treatment-Naive

Patients that have not received treatment for polypoidal choroidal vasculopathy.

Intervention: Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for treatment-naive arm.

Group Type: ACTIVE_COMPARATOR

Intravitreal aflibercept injection 2.0mg

Intervention Type: DRUG

Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms.

Interventions

Intravitreal aflibercept injection 2.0mg

Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms.

Intervention Type: DRUG

Other Intervention Names

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)

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Gregg T. Kokame, MD

OTHER

Sponsor Role: lead

Responsible Party

Gregg T. Kokame, MD

Primary Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gregg T. Kokame, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

Hawaii Pacific Health

Locations

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27465105 (View on PubMed)

Other Identifiers

EPIC

Identifier Type: -

Identifier Source: org_study_id