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Polypoidal Choroidal VasculopathyPhase 4EPICNCT01871376

Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

A Phase 4 study testing Intravitreal aflibercept injection 2.0mg in people with Polypoidal Choroidal Vasculopathy, run by Gregg T. Kokame, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for
Polypoidal Choroidal Vasculopathy
What is being tested?
Intravitreal aflibercept injection 2.0mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
May 2013to Sep 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

Other trials in United States

About this study

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

Read the 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®.

Being tested
Intravitreal aflibercept injection 2.0mg
Keywords
PCV
Medical subject headings
Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal aflibercept injection 2.0mgDrug

    Also called Eylea

    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.

Study groups in NCT01871376
Study groupRoleWhat they receive
Previously TreatedActive comparatorPatients 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.
Receives: Drug: Intravitreal aflibercept injection 2.0mg
Treatment-NaiveActive comparatorPatients 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.
Receives: Drug: Intravitreal aflibercept injection 2.0mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 Years

Secondary outcomes (9)

  1. 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

    Measured: 6 Months, 12 Months, 18 Months, 24 Months

  2. 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

    Measured: Month 6, Month 12, Month 18, Month 24

  3. 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

    Measured: Month 3, Month 6, Month 12, Month 18, Month 24

  4. 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

    Measured: Month 3, Month 6, Month 12, Month 18, Month 24

  5. 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)

    Measured: Baseline, Month 6, Month 12, Month 18, Month 24

  6. 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)

    Measured: Baseline, Month 6, Month 12, Month 18, Month 24

  7. 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)

    Measured: Month 24

  8. 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)

    Measured: Baseline, Month 6, Month 12, Month 18, Month 24

  9. 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)

    Measured: Baseline through Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871376
Sponsor's protocol ID
EPIC
Acronym
EPIC
Status last verified
Nov 2016
First submitted
4 Jun 2013
Last updated
23 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27465105

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal aflibercept injection 2.0mg in people with Polypoidal Choroidal Vasculopathy, run by Gregg T. Kokame, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy of intravitreal aflibercept injection of 2.0mg aflibercept (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.

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