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

November 16, 2023 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 814-0180
      • Fukuoka, Japan, 812-8582
      • Miyazaki, Japan, 889-1692
      • Okayama, Japan, 700-8558
      • Osaka, Japan, 545-8586
      • Osaka, Japan, 533-0024
    • Aichi
      • Ichinomiya, Aichi, Japan, 491-8551
      • Nagoya, Aichi, Japan, 457-8510
      • Nagoya, Aichi, Japan, 467-8602
      • Toyoake, Aichi, Japan, 470-1192
    • Chiba
      • Asahi, Chiba, Japan, 289-2511
      • Sakura, Chiba, Japan, 285-8741
    • Fukushima
      • Koriyama, Fukushima, Japan, 963-8052
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0029
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 001-0016
      • Sapporo, Hokkaido, Japan, 060-0010
      • Sapporo, Hokkaido, Japan, 065-0031
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Mito, Ibaraki, Japan, 310-0845
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
    • Miyazaki
      • Miyakonojo, Miyazaki, Japan, 885-0051
    • Nagano
      • Iida, Nagano, Japan, 395-8502
      • Matsumoto, Nagano, Japan, 390-8621
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
      • Moriguchi, Osaka, Japan, 570-8507
      • Osakasayama, Osaka, Japan, 589-8511
      • Takatsuki, Osaka, Japan, 569-1096
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Chuoku, Tokyo, Japan, 104-8560
      • Hachioji, Tokyo, Japan, 193-0998
      • Mitaka, Tokyo, Japan, 181-8611
      • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Taito-ku, Tokyo, Japan, 111-0051
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-0061
      • Ube, Yamaguchi, Japan, 755-8505
    • Yamanashi
      • Chuo, Yamanashi, Japan, 409-3898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 Weeks adjustment
Participants 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.
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.
Experimental: 4 Weeks adjustment
Participants 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.
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in BCVA at Week 52
Time Frame: Baseline and 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.
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Maintained Vision at Week 52
Time Frame: 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.
Week 52
Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52
Time Frame: Baseline and week 52
Baseline and week 52
Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52
Time Frame: Week 52
A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2014

Primary Completion (Actual)

December 22, 2016

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimated)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17668

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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