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Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation (EPIC)

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intravitreal aflibercept injection 2.0mg

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring PCV

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Retina Consultants of Hawaii

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Previously Treated

Treatment-Naive

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

efficacy of intravitreal aflibercept injection of 2.0mg aflibercept

This study will evaluate the efficacy of intravitreal aflibercept injection of 2.0mg aflibercept administered Q8W following an initial loading dose of 3 monthly injections in patients with polypoidal choroidal vasculopathy with active exudation or bleeding as measured by: • Mean change in BCVA between Day 0 (Baseline) and Day 720 (M24)

Secondary Outcome Measures

Proportion of Patients with Stable, Improved, Significant Improved, Decreased, Significant Decreased Vision

To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) with "Stable" vision <5 letters gained or lost, "Improved" vision >5 letters gained, "Significant Improved" vision ≥15 letters gained, "Decreased" vision >5 letters lost, "Significant Decreased" vision ≥15 letters lost

Proportion of Patients with decrease in Subretinal Hemorrhage and/or Exudates

To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18), Day 720 (M24) in decreasing subretinal hemorrhage and/or subretinal exudates via fundus photos and fundus exams

Proportion of patients with decreased / complete resolution of Polypoidal Polyp.

To evaluate the proportion of subjects with a decrease and/or complete resolution of polypoidal polyps from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) as assessed by fluorescein and indocyanine green angiography

Proportion of subject with a decrease or complete resolution of branching vascular network from PCV

To identify the proportion of subjects with a decrease and/or complete resolution of branching vascular network (BVN) from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) months as assessed by fluorescein and indocyanine green angiography

Determine mean change in Central Foveal Thickness and/or peripapillary edema as measured by SD-OCT

To determine mean change in central foveal thickness (CFT) and/or peripapillary edema as measured by spectral domain optical coherence tomography (SD-OCT) in central and/or paracentral fields from Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24)

Mean Change in Choroidal Thickness

To determine mean change in choroidal thickness (at fovea) as imaged via EDI-OCT between Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18), and Day 720 (M24)

Proportion of previously treated and treatment naive patients that require additional dosing outside of the protocol determined dosing schedule

To identify proportion of patients between previously treated and treatment naïve patients that require additional dosing outside of the protocol determined dosing schedule: 3- initial monthly dosing followed by dosing every other month for 720 days (M24)

Assess changes on Autofluorescence

To assess changes on autofluorescence (AF) as seen on images from Day 1 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24)

Incidence and Severity of Ocular and Non-Ocular Adverse Events

To determine the incidence and severity of ocular and non-ocular adverse events from Day 1(Baseline) through the end of the study (Day 720)

Full Information

NCT ID

NCT01871376

First Posted

June 4, 2013

Last Updated

November 22, 2016

Sponsor

Gregg T. Kokame, MD

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01871376

Brief Title

Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

Acronym

EPIC

Official Title

Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gregg T. Kokame, MD

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polypoidal Choroidal Vasculopathy

Keywords

PCV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Previously Treated

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment-Naive

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Intravitreal aflibercept injection 2.0mg

Other Intervention Name(s)

Eylea

Intervention Description

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.

Primary Outcome Measure Information:

Title

efficacy of intravitreal aflibercept injection of 2.0mg aflibercept

Description

Time Frame

2 Years

Secondary Outcome Measure Information:

Title

Proportion of Patients with Stable, Improved, Significant Improved, Decreased, Significant Decreased Vision

Description

Time Frame

6 Months, 12 Months, 18 Months, 24 Months

Title

Proportion of Patients with decrease in Subretinal Hemorrhage and/or Exudates

Description

To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18), Day 720 (M24) in decreasing subretinal hemorrhage and/or subretinal exudates via fundus photos and fundus exams

Time Frame

Month 6, Month 12, Month 18, Month 24

Title

Proportion of patients with decreased / complete resolution of Polypoidal Polyp.

Description

Time Frame

Month 3, Month 6, Month 12, Month 18, Month 24

Title

Proportion of subject with a decrease or complete resolution of branching vascular network from PCV

Description

Time Frame

Month 3, Month 6, Month 12, Month 18, Month 24

Title

Determine mean change in Central Foveal Thickness and/or peripapillary edema as measured by SD-OCT

Description

Time Frame

Baseline, Month 6, Month 12, Month 18, Month 24

Title

Mean Change in Choroidal Thickness

Description

To determine mean change in choroidal thickness (at fovea) as imaged via EDI-OCT between Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18), and Day 720 (M24)

Time Frame

Baseline, Month 6, Month 12, Month 18, Month 24

Title

Proportion of previously treated and treatment naive patients that require additional dosing outside of the protocol determined dosing schedule

Description

Time Frame

Month 24

Title

Assess changes on Autofluorescence

Description

To assess changes on autofluorescence (AF) as seen on images from Day 1 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24)

Time Frame

Baseline, Month 6, Month 12, Month 18, Month 24

Title

Incidence and Severity of Ocular and Non-Ocular Adverse Events

Description

To determine the incidence and severity of ocular and non-ocular adverse events from Day 1(Baseline) through the end of the study (Day 720)

Time Frame

Baseline through Month 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregg T. Kokame, MD, MMS

Organizational Affiliation

Hawaii Pacific Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Retina Consultants of Hawaii

City

Aiea

State/Province

Hawaii

ZIP/Postal Code

96701

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27465105

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.

Results Reference

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Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

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