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

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ClinicalTrials.gov Identifier: NCT02305238
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2014
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Mean Change From Baseline in BCVA at Week 52 [ Time Frame: Baseline and Week 52 ]
    Visual functions of the study eye (at every visit) were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.


Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52 [ Time Frame: Baseline and Week 52 ]
  3. Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52 [ Time Frame: Baseline and week 52 ]
  4. Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52 [ Time Frame: Week 52 ]
    Retinal and lesion characteristics were evaluated, using OCT, for the study eye at every visit. A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305238


Locations
Japan
Ichinomiya, Aichi, Japan, 491-8551
Nagoya, Aichi, Japan, 457-8510
Nagoya, Aichi, Japan, 467-8602
Toyoake, Aichi, Japan, 470-1192
Asahi, Chiba, Japan, 289-2511
Sakura, Chiba, Japan, 285-8741
Koriyama, Fukushima, Japan, 963-8052
Kure, Hiroshima, Japan, 737-0029
Hakodate, Hokkaido, Japan, 041-0851
Sapporo, Hokkaido, Japan, 001-0016
Sapporo, Hokkaido, Japan, 060-0010
Sapporo, Hokkaido, Japan, 065-0031
Kobe, Hyogo, Japan, 650-0047
Inashiki-gun, Ibaraki, Japan, 300-0395
Mito, Ibaraki, Japan, 310-0845
Morioka, Iwate, Japan, 020-8505
Yokohama, Kanagawa, Japan, 232-0024
Nankoku, Kochi, Japan, 783-8505
Miyakonojo, Miyazaki, Japan, 885-0051
Iida, Nagano, Japan, 395-8502
Matsumoto, Nagano, Japan, 390-8621
Hirakata, Osaka, Japan, 573-1191
Moriguchi, Osaka, Japan, 570-8507
Osakasayama, Osaka, Japan, 589-8511
Takatsuki, Osaka, Japan, 569-1096
Otsu, Shiga, Japan, 520-2192
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
Shimonoseki, Yamaguchi, Japan, 750-0061
Ube, Yamaguchi, Japan, 755-8505
Chuo, Yamanashi, Japan, 409-3898
Fukuoka, Japan, 812-8582
Fukuoka, Japan, 814-0180
Miyazaki, Japan, 889-1692
Okayama, Japan, 700-8558
Osaka, Japan, 533-0024
Osaka, Japan, 545-8586
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02305238     History of Changes
Other Study ID Numbers: 17668
First Posted: December 2, 2014    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018
Last Verified: March 2018

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

Keywords provided by Bayer:
Eylea,
Aflibercept
Treat and Extend regimen
Age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases