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Neovascular Age-related Macular DegenerationPhase 4NCT01918878

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

A Phase 4 study testing Aflibercept (EYLEA) in people with Neovascular Age-related Macular Degeneration, run by Hadassah Medical Organization at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Aflibercept (EYLEA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteIsrael
Study dates
Oct 2013to Apr 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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ophthalmic Inclusion Criteria
  • Failure of previous intravitreal bevacizumab or ranibizumab treatment, defined as:
  • 3-6 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.
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  • 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.
  • General Inclusion Criteria
  • 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.
  • -

Who cannot join

  • Ophthalmic Exclusion Criteria
  • 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.
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  • 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.
  • General Exclusion Criteria
  • 1. 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.
  • Stroke (within 3 months of trial entry).
  • Any major surgical procedure within one month of trial entry.
  • 2. Any treatment with an investigational agent in the 60 days prior to trial entry for any condition.
  • 3. Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the bevacizumab, or aflibercept formulation.
  • 4. Women of child-bearing potential.
  • -

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah Medical Organization

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: A 7-month, Multicenter Study to Evaluate the Efficacy of Intravitreal Injections of Aflibercept (EYLEA) 2mg /0.05 ml as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration (NVAMD).

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.

Read the detailed description

The aim of this study is to prospectively evaluate the use of aflibercept in patients in whom initial incomplete response or loss of initial response for other intravitreal anti- vascular endothelial growth factor (anti-VEGF) therapy was demonstrated.

This is a multi-center study initiated and conducted by the Israeli retina association. Each center participating in the study will follow the same protocol including standardized measurement of visual acuity, OCT, and Fluorescein angiography (FA).

We will enroll 48 NVAMD patients which are partial or non-responded for 3-6 injections of intravitreal bevacizumab or ranibizumab and no more than one year of treatment .

Test Treatment:

Monthly intravitreal aflibercept 2mg /0.05 ml will be given at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks, and 24 weeks after the initial enrollment for the study group.

Follow-up period will be 28 weeks,7 visits. At the 28 week visit the primary and secondary end points will be evaluated.

Being tested
Aflibercept (EYLEA)
Keywords
age-related macular degeneration, intravitreal injections, Aflibercept, EYLEA
Medical subject headings
Macular Degeneration

What participants receive

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

  • Aflibercept (EYLEA)Drug

    Also called EYLEA

    INTARAVITREAL INJECTION OF AFLIBERCEPT

Study groups in NCT01918878
Study groupRoleWhat they receive
Aflibercept (EYLEA)ExperimentalIntravitreal 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
Receives: Drug: Aflibercept (EYLEA)

What is being measured

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

  1. Central macular thickness change

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

    Measured: at week 28

Secondary outcomes (1)

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

    1. The mean change in best corrected ETDRS visual acuity at 4 meters according to a standardized protocol.
    2. Gain or loss of 3-lines of visual acuity as defined above.
    3. Change in CNV size according to fluorescein angiogram, following a standardized protocol.

    Measured: at week 28

Timeline

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

  1. First posted8 Aug 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2016 (estimated)
  4. Study completionApr 2016 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01918878
Sponsor's protocol ID
CHO123-HMO-CTIL
Status last verified
Sep 2015
First submitted
7 Aug 2013
Last updated
13 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept (EYLEA) in people with Neovascular Age-related Macular Degeneration, run by Hadassah Medical Organization at 1 site in Israel.

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 16 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 13 Jan 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 Israel. 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?

Results are not available in the source record.

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?

Central macular thickness change (time frame: at week 28). 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 NCT01918878.

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 13 Jan 2016.

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