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

Primary Purpose

Wet Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring Eylea,, Aflibercept, Treat and Extend regimen, Age-related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2 Weeks adjustment

4 Weeks adjustment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52
Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52
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".

Full Information

First Posted
November 28, 2014
Last Updated
December 20, 2018
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02305238
Brief Title
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
Acronym
ALTAIR
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 19, 2014 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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) . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration
Keywords
Eylea,, Aflibercept, Treat and Extend regimen, Age-related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 Weeks adjustment
Arm Type
Experimental
Arm Description
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.
Arm Title
4 Weeks adjustment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention Description
Aflibercept 2mg is intravitreally injected.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in BCVA at Week 52
Description
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.
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Maintained Vision at Week 52
Description
A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Time Frame
Week 52
Title
Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52
Time Frame
Baseline and Week 52
Title
Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52
Time Frame
Baseline and week 52
Title
Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52
Description
A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Ichinomiya
State/Province
Aichi
ZIP/Postal Code
491-8551
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0029
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
001-0016
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0010
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
065-0031
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0845
Country
Japan
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
City
Nankoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
City
Miyakonojo
State/Province
Miyazaki
ZIP/Postal Code
885-0051
Country
Japan
City
Iida
State/Province
Nagano
ZIP/Postal Code
395-8502
Country
Japan
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
City
Chuoku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Taito-ku
State/Province
Tokyo
ZIP/Postal Code
111-0051
Country
Japan
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
750-0061
Country
Japan
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Osaka
ZIP/Postal Code
533-0024
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35503499
Citation
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.
Results Reference
derived
PubMed Identifier
34283294
Citation
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. Erratum In: Graefes Arch Clin Exp Ophthalmol. 2022 Jul;260(7):2395-2396.
Results Reference
derived
PubMed Identifier
32016788
Citation
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
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Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

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