check_circleStudy Completed

Wet macular degeneration

Bayer Identifier:

17668

ClinicalTrials.gov Identifier:

NCT02305238

EudraCT Number:

Not Available

EU CT Number:

Not Available
Japanese Treat and Extend study of Aflibercept in Neovascular age-related Macular Degeneration

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

50 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
288
Trial Dates
December 2014 - December 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mito, 310-0845, Japan
Completed
Nagoya, 457-8510, Japan
Completed
Osaka, 545-8586, Japan
Completed
Sapporo, 001-0016, Japan
Completed
Yokohama, 232-0024, Japan
Completed
Hirakata, 573-1191, Japan
Completed
Ube, 755-8505, Japan
Completed
Fukuoka, 814-0180, Japan
Completed
Miyakonojo, 885-0051, Japan
Completed
Shinjuku-ku, 160-0023, Japan
Completed
Sakura, 285-8741, Japan
Completed
Nagoya, 467-8602, Japan
Completed
Toyoake, 470-1192, Japan
Completed
Otsu, 520-2192, Japan
Completed
Moriguchi, 570-8507, Japan
Completed
Miyazaki, 889-1692, Japan
Withdrawn
Hakodate, 041-0851, Japan
Completed
Kobe, 650-0047, Japan
Completed
Morioka, 020-8505, Japan
Completed
Koriyama, 963-8052, Japan
Completed
Kure, 737-0029, Japan
Completed
Nankoku, 783-8505, Japan
Completed
Shinjuku-ku, 162-8666, Japan
Completed
Hachioji, 193-0998, Japan
Completed
Sapporo, 065-0031, Japan
Completed
Inashiki-gun, 300-0395, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Chiyoda-ku, 101-8309, Japan
Completed
Chuo, 409-3898, Japan
Completed
Ichinomiya, 491-8551, Japan
Completed
Takatsuki, 569-1096, Japan
Completed
Osaka, 533-0024, Japan
Completed
Osakasayama, 589-8511, Japan
Completed
Taito-ku, 111-0051, Japan
Completed
Chuoku, 104-8560, Japan
Completed
Shimonoseki, 750-0061, Japan
Completed
Asahi, 289-2511, Japan
Completed
Iida, 395-8502, Japan
Completed
Sapporo, 060-0010, Japan
Completed
Matsumoto, 390-8621, Japan
Completed
Okayama, 700-8558, Japan
Completed
Fukuoka, 812-8582, Japan

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Baseline and Week 52
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    Week 52
  • Percentage of participants who gained at least 15 letters of vision compared to baseline at Week 52
    date_rangeTime Frame:
    Baseline and Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in Central Retinal Thickness (CRT) from baseline at Week 52
    date_rangeTime Frame:
    Baseline and week 52
    enhanced_encryption
    Safety Issue:
    No
  • 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”.
    date_rangeTime Frame:
    Week 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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