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Macular DegenerationPhase 3NCT02540954

Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

A Phase 3 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Bayer at 71 sites in 14 countries.

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 compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD) Read more about this study

Who is it for?
Ages 51 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
71 sitesin 14 countries
Study dates
29 Sep 2015to 4 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 51 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study):
  • Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment.
  • The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
  • Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment.
  • Men and women >= 51 years of age
  • The subject's history of aflibercept treatment meets ALL of the following:
  • Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
  • Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks

Who cannot join

  • Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.
  • Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
  • Subretinal hemorrhage that was:
  • 50% or more of the total lesion area, or
  • if the blood was under the fovea, and
  • the blood under the fovea was 1 or more disc areas in size in the study eye.
Show all 10Show fewer
  • Scar or fibrosis making up more than 50% of the total lesion in the study eye.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  • Causes of CNV other than AMD in the study eye.

Trial locations and contacts

71 sites in 14 countries.

71 sites in 14 countries

United Kingdom15 sites

  • Study site

    Colchester, CO3 3NB

  • Study site

    Great Yarmouth, Norfolk, NR31 6LA

  • Study site

    Guildford, Surrey, GU2 7XX

  • Study site

    Hull, York, HU3 2JZ

  • Study site

    Liverpool, Merseyside, L7 8XP

  • Study site

    London, NW1 5QH

  • Study site

    London, SE5 9RS

  • Study site

    Manchester, M13 9WL

  • Study site

    Middlesbrough, North Yorkshire, TS4 3BW

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

  • Study site

    Pont-y-clun, Rhondda, Cynon, Taff, CF72 8XR

  • Study site

    Rugby, Warwickshire, CV22 5PX

  • Study site

    Southampton, Hampshire, SO16 6YD

  • Study site

    Sunderland, Tyne and Wear, SR2 9HP

  • Study site

    Wakefield, West Yorkshire, WF1 4DG

Other trials in United Kingdom

Italy12 sites

  • Study site

    Brescia, Lombardy, 25015

  • Study site

    Catania, Sicily, 95123

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20157

  • Study site

    Parma, 43126

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Rome, Lazio, 00133

  • Study site

    Rome, Lazio, 00198

  • Study site

    Turin, Piedmont, 10122

  • Study site

    Verona, Veneto, 37134

Other trials in Italy

Germany10 sites

  • Study site

    Berlin, 10713

  • Study site

    Berlin, 12203

  • Study site

    Darmstadt, Hesse, 64297

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Hamburg, 20251

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Marburg, Hesse, 35037

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

France6 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Dijon, BP 1542-21

  • Study site

    Lyon, 69317

  • Study site

    Nice, 06006

  • Study site

    Paris, Cedex 12, 75557

  • Study site

    Paris, 75010

Other trials in France

Czechia5 sites

  • Study site

    Hradec Králové, 500 05

  • Study site

    Pilsen, 304 60

  • Study site

    Prague, 100 34

  • Study site

    Prague, 12808

  • Study site

    Prague, 150 00

Other trials in Czechia

Portugal4 sites

  • Study site

    Coimbra, 3000-548

  • Study site

    Leiria, 2410-197

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 4200-319

Other trials in Portugal

Hungary3 sites

  • Study site

    Budapest, 1085

  • Study site

    Debrecen, 4032

  • Study site

    Pécs, 7621

Other trials in Hungary

Slovakia3 sites

  • Study site

    Bratislava, 826 06

  • Study site

    Bratislava, 851 07

  • Study site

    Nitra, 949 01

Other trials in Slovakia

Spain3 sites

  • Study site

    Barcelona, 08036

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Valencia, 46014

Other trials in Spain

Austria2 sites

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1140

Other trials in Austria

Canada2 sites

  • Clinique medicale de l'oeil de l'Estrie

    Sherbrooke, Quebec, J1J 2B8

  • Study site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Lithuania2 sites

  • Study site

    Kaunas, LT-50009

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

Poland2 sites

  • Study site

    Gdansk, 80-809

  • Study site

    Olsztyn, 10-424

Other trials in Poland

Switzerland2 sites

  • Study site

    Bern

  • Study site

    Geneva, 1204

Other trials in Switzerland

About this study

Official title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).

To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

Read the detailed description

330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.

Being tested
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Keywords
Age-related macular degeneration (AMD), Eylea treatment, Treat and Extend, Intravitreal
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, VEGF Trap-Eye, BAY86-5321)Drug

    A dose of 2 mg aflibercept injected intravitreally

Study groups in NCT02540954
Study groupRoleWhat they receive
Aflibercept extended dosingExperimentalAflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks)Active comparatorAflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

What is being measured

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

  1. Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye

    Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.

    Measured: From baseline to Week 52

Secondary outcomes (7)

  1. Percentage of Participants Maintaining Vision in the Study Eye

    A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.

    Measured: At week 52

  2. Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye

    Measured: At week 52

  3. Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Retinal characteristic was evaluated using Optical coherence tomography (OCT).

    Measured: From baseline to week 52

  4. Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye

    Choroidal neovascularization measured by optical coherence tomography (OCT).

    Measured: From baseline to week 52

  5. Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye

    Measured: At week 52

  6. Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire

    National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst.

    Measured: From baseline to week 52

  7. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    Measured: Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years

Timeline

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

  1. First posted4 Sep 2015 (estimated)
  2. Study start29 Sep 2015
  3. Primary completion24 Dec 2019
  4. Study completion4 Jun 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02540954
Sponsor's protocol ID
16598
Other IDs
2013-000120-33
Status last verified
Jun 2021
First submitted
2 Sep 2015
Last updated
11 Jun 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Kodjikian L, Arias Barquet L, Papp A, Kertes PJ, Midena E, Ernest J, Silva R, Schmelter T, Niesen T, Leal S. Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing. Adv Ther. 2024 Mar;41(3):1010-1024. doi: 10.1007/s12325-023-02719-3. Epub 2024 Jan 6.

    PubMed 38183525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Bayer at 71 sites in 14 countries.

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 8 inclusion and 10 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United Kingdom, Italy, Germany, France, Czechia and 9 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye (time frame: From baseline to Week 52). 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 NCT02540954, 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 11 Jun 2021.

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