NCT02305238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

December 19, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 12, 2018

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 28, 2014

Results QC Date

December 14, 2017

Last Update Submit

November 16, 2023

Conditions

Wet Macular Degeneration

Keywords

Eylea,AfliberceptTreat and Extend regimenAge-related macular degeneration

Outcome Measures

Primary Outcomes (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.

    Baseline and Week 52

Secondary Outcomes (4)

  • Percentage of Participants Who Maintained Vision at Week 52

    Week 52

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

    Baseline and Week 52

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

    Baseline and week 52

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

    Week 52

Study Arms (2)

2 Weeks adjustment

EXPERIMENTAL

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)

4 Weeks adjustment

EXPERIMENTAL

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)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)DRUG

Aflibercept 2mg is intravitreally injected.

2 Weeks adjustment4 Weeks adjustment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Unknown Facility

Ichinomiya, Aichi-ken, 491-8551, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 457-8510, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-8602, Japan

Location

Unknown Facility

Toyoake, Aichi-ken, 470-1192, Japan

Location

Unknown Facility

Asahi, Chiba, 289-2511, Japan

Location

Unknown Facility

Sakura, Chiba, 285-8741, Japan

Location

Unknown Facility

Kōriyama, Fukushima, 963-8052, Japan

Location

Unknown Facility

Kure, Hiroshima, 737-0029, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 001-0016, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-0010, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 065-0031, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0047, Japan

Location

Unknown Facility

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

Unknown Facility

Mito, Ibaraki, 310-0845, Japan

Location

Unknown Facility

Morioka, Iwate, 020-8505, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 232-0024, Japan

Location

Unknown Facility

Nankoku, Kochi, 783-8505, Japan

Location

Unknown Facility

Miyakonojō, Miyazaki, 885-0051, Japan

Location

Unknown Facility

Iida, Nagano, 395-8502, Japan

Location

Unknown Facility

Matsumoto, Nagano, 390-8621, Japan

Location

Unknown Facility

Hirakata, Osaka, 573-1191, Japan

Location

Unknown Facility

Moriguchi, Osaka, 570-8507, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Takatsuki, Osaka, 569-1096, Japan

Location

Unknown Facility

Ōtsu, Shiga, 520-2192, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Unknown Facility

Chuoku, Tokyo, 104-8560, Japan

Location

Unknown Facility

Hachiōji, Tokyo, 193-0998, Japan

Location

Unknown Facility

Mitaka, Tokyo, 181-8611, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Unknown Facility

Taito-ku, Tokyo, 111-0051, Japan

Location

Unknown Facility

Shimonoseki, Yamaguchi, 750-0061, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-8505, Japan

Location

Unknown Facility

Chūō, Yamanashi, 409-3898, Japan

Location

Unknown Facility

Fukuoka, 812-8582, Japan

Location

Unknown Facility

Fukuoka, 814-0180, Japan

Location

Unknown Facility

Miyazaki, 889-1692, Japan

Location

Unknown Facility

Okayama, 700-8558, Japan

Location

Unknown Facility

Osaka, 533-0024, Japan

Location

Unknown Facility

Osaka, 545-8586, Japan

Location

Related Publications (3)

  • 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.

    PMID: 35503499RESULT

  • 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.

    PMID: 34283294DERIVED

  • 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.

    PMID: 32016788DERIVED

Related Links

MeSH Terms

Conditions

Wet Macular DegenerationMacular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Results Point of Contact

Title
Therapeutic Area Head
Organization
Bayer
clinical-trials-contact@bayer.com
(+) 1-888-8422937

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 2, 2014

Study Start

December 19, 2014

Primary Completion

December 22, 2016

Study Completion

December 20, 2017

Last Updated

November 18, 2023

Results First Posted

March 12, 2018

Record last verified: 2023-11

Locations

JP(41)