Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

NCT01871376 | Completed Phase 4

• 1 other identifier: EPIC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

PCV

Outcome Measures

Primary Outcomes (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)

  2 Years

Secondary Outcomes (9)

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

  6 Months, 12 Months, 18 Months, 24 Months

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

  Month 6, Month 12, Month 18, Month 24

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

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

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

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

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

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

Study Arms (2)

Previously Treated

ACTIVE COMPARATOR

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.

Drug: Intravitreal aflibercept injection 2.0mg

Treatment-Naive

ACTIVE COMPARATOR

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.

Drug: Intravitreal aflibercept injection 2.0mg

Interventions

Intravitreal aflibercept injection 2.0mg 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.

Also known as: Eylea

Previously Treated; Treatment-Naive

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gregg T. Kokame, MD: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

Related Publications (1)

• 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.

  PMID: 27465105 DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregg T. Kokame, MD, MMS

  Hawaii Pacific Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

US (1)