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Wet Macular DegenerationPhase 4ALTAIRNCT02305238

Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

A Phase 4 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in people with Wet Macular Degeneration, run by Bayer at 41 sites in Japan.

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 assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) . Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet 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
288 participants
Where
41 sitesJapan
Study dates
19 Dec 2014to 20 Dec 2017
Phase
Phase 4
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Japanese men and women ≥ 50 years of age
  • Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD, including juxta-foveal lesions that affect the fovea as evidenced by fluorescein angiography (FA) in the study eye
  • Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study eye

Who cannot join

  • Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser, intraocular corticosteroids, surgical interventions (except cataract surgery more than 30 days prior to screening) or systemic use of anti-VEGF products within 3 months prior to study entry
  • Active or suspected infection in or surrounding of the study eye
  • Active severe intraocular inflammation in the study eye
  • Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
  • Ocular condition in the study eye which may impact vision and confound study outcomes

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Japan41 sites

  • Study site

    Asahi, Chiba, 289-2511

  • Study site

    Chiyoda-ku, Tokyo, 101-8309

  • Study site

    Chūō, Yamanashi, 409-3898

  • Study site

    Chuoku, Tokyo, 104-8560

  • Study site

    Fukuoka, 812-8582

  • Study site

    Fukuoka, 814-0180

  • Study site

    Hachiōji, Tokyo, 193-0998

  • Study site

    Hirakata, Osaka, 573-1191

  • Study site

    Ichinomiya, Aichi-ken, 491-8551

  • Study site

    Iida, Nagano, 395-8502

  • Study site

    Inashiki-gun, Ibaraki, 300-0395

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Kōriyama, Fukushima, 963-8052

  • Study site

    Kure, Hiroshima, 737-0029

  • Study site

    Matsumoto, Nagano, 390-8621

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Mito, Ibaraki, 310-0845

  • Study site

    Miyakonojō, Miyazaki, 885-0051

  • Study site

    Miyazaki, 889-1692

  • Study site

    Moriguchi, Osaka, 570-8507

  • Study site

    Morioka, Iwate, 020-8505

  • Study site

    Nagoya, Aichi-ken, 457-8510

  • Study site

    Nagoya, Aichi-ken, 467-8602

  • Study site

    Nankoku, Kochi, 783-8505

  • Study site

    Okayama, 700-8558

  • Study site

    Osaka, 533-0024

  • Study site

    Osaka, 545-8586

  • Study site

    Ōtsu, Shiga, 520-2192

  • Study site

    Sakura, Chiba, 285-8741

  • Study site

    Sapporo, Hokkaido, 001-0016

  • Study site

    Sapporo, Hokkaido, 060-0010

  • Study site

    Sapporo, Hokkaido, 065-0031

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Shimonoseki, Yamaguchi, 750-0061

  • Study site

    Shinjuku-ku, Tokyo, 160-0023

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    Taito-ku, Tokyo, 111-0051

  • Study site

    Takatsuki, Osaka, 569-1096

  • Study site

    Toyoake, Aichi-ken, 470-1192

  • Study site

    Ube, Yamaguchi, 755-8505

  • Study site

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

About this study

Official title: A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration

To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) .

To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.

Being tested
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Keywords
Eylea,, Aflibercept, Treat and Extend regimen, Age-related macular degeneration
Medical subject headings
Wet Macular Degeneration, 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

    Aflibercept 2mg is intravitreally injected.

Study groups in NCT02305238
Study groupRoleWhat they receive
2 Weeks adjustmentExperimentalParticipants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
4 Weeks adjustmentExperimentalParticipants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
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 From Baseline in BCVA at Week 52

    Visual functions of the study eye (at every visit) and the fellow eye were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.

    Measured: Baseline and Week 52

Secondary outcomes (4)

  1. Percentage of Participants Who Maintained Vision at Week 52

    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: Week 52

  2. Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52

    Measured: Baseline and Week 52

  3. Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52

    Measured: Baseline and week 52

  4. Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52

    A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".

    Measured: Week 52

Timeline

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

  1. First posted2 Dec 2014 (estimated)
  2. Study start19 Dec 2014
  3. Primary completion22 Dec 2016
  4. Study completion20 Dec 2017

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305238
Sponsor's protocol ID
17668
Acronym
ALTAIR
Status last verified
Nov 2023
First submitted
28 Nov 2014
Last updated
18 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Okada AA, Takahashi K, Ohji M, Moon SC, Machewitz T, Sasaki K; ALTAIR Study Investigators. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup. Adv Ther. 2022 Jun;39(6):2984-2998. doi: 10.1007/s12325-022-02162-w. Epub 2022 May 3.

    PubMed 35503499

  • Ohji M, Okada AA, Sasaki K, Moon SC, Machewitz T, Takahashi K; ALTAIR Investigators. Relationship between retinal fluid and visual acuity in patients with exudative age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: subgroup and post-hoc analyses from the ALTAIR study. Graefes Arch Clin Exp Ophthalmol. 2021 Dec;259(12):3637-3647. doi: 10.1007/s00417-021-05293-y. Epub 2021 Jul 20.

    PubMed 34283294

  • Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y; ALTAIR Investigators. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial. Adv Ther. 2020 Mar;37(3):1173-1187. doi: 10.1007/s12325-020-01236-x. Epub 2020 Feb 3.

    PubMed 32016788

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in people with Wet Macular Degeneration, run by Bayer at 41 sites in Japan.

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 3 inclusion and 5 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 12 Mar 2018). 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 From Baseline in BCVA at Week 52 (time frame: Baseline and 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 NCT02305238, which also lists 3 linked publications.

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 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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