Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration.

NCT01918878 | Unknown Phase 4

• 1 other identifier: CHO123-HMO-CTIL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, single arm study. The study group will be compose of NVAMD patients who had partial or complete failure responding to initial bevacizumab or ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits. Aflibercept will be provided for total period of 24 weeks.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

age-related macular degeneration; intravitreal injections; Aflibercept; EYLEA

Outcome Measures

Primary Outcomes (1)

• Central macular thickness change

  Central macular thickness change from baseline on optical coherence tomography (OCT) at week 28.

  at week 28

Secondary Outcomes (1)

• change in best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity and Change in CNV size

  at week 28

Other Outcomes (1)

• Presence or intraretinal fluid, sub-retinal fluid, or pigment epithelial detachment .

  at week 28

Study Arms (1)

Aflibercept (EYLEA)

EXPERIMENTAL

Intravitreal injection of aflibercept (EYLEA) 2mg/0.05ml at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks and 24 weeks. Aflibercept will be provided for total period of 24 weeks

Drug: Aflibercept (EYLEA)

Interventions

Aflibercept (EYLEA) DRUG

INTARAVITREAL INJECTION OF AFLIBERCEPT

Also known as: EYLEA

Aflibercept (EYLEA)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Failure of previous intravitreal bevacizumab or ranibizumab treatment, defined as:
• intravitreal injections (The last 3 injections must be no more than 6 weeks between one injection to another).
• Maximal central thickness by Heidelberg OCT has to be at least 300 microns or larger (retinal thickness including subretinal fluid {SRF},intraretinal fluid {IRF} and PED).
• Subfoveal choroidal neovascularization (CNV) due to AMD as documented by fluorescein angiogram.
• Best corrected visual acuity in the study eye between 20/40 and 20/360, inclusive. The VA must be re-confirmed at Day 0 prior to initiation of treatment.
• Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be ≤ 5 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as the neovascular component of the lesion as defined by the fluorescein angiogram.
• Presence on OCT of subretinal, intraretinal or sub-retinal pigment epithelial (RPE) fluid and/or subretinal thickening consistent with active CNV.
• Clear ocular media and adequate pupillary dilatation
• Intraocular pressure (IOP) of 21 mmHg or less.
• Subjects of either gender, aged above 50 years.
• Women should be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
• Provide written informed consent.
• Ability to comply with study and follow-up procedures and return for all trial visits.

You may not qualify if:

• More than 50% of the total lesion size consisting of subretinal hemorrhage.
• Presence of retinal angiomatous proliferation (RAP).
• Presence of pigment epithelial tears.
• Hypersensitivity to the active substance aflibercept or to any of the excipients.
• Active or suspected ocular or periocular infection.
• Active severe intraocular inflammation (≥ trace cell or flare), significant epiretinal membrane or vitreomacular traction, macular hole or vitreous hemorrhage.
• Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation.
• History of idiopathic or autoimmune-associated uveitis in either eye.
• Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 7 months.
• Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
• Any intraocular surgery or thermal laser within three (3) months of trial entry.
• History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.
• Previous therapeutic radiation in the region of the study eye.
• \. Any of the following underlying diseases including:
• Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Bayer: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Itay Chowers, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 8, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 13, 2016

Record last verified: 2015-09

Locations

IL (1)