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Completed

NCT Number: NCT02305238

Japanese Treat and Extend Study of Aflibercept in 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.

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ichinomiya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Aflibercept 2mg is intravitreally injected.

Primary outcomes

  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) 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 outcomes

  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

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: ALTAIR

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 2, 2014
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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