Trial Condition(s):

Wet Macular Degeneration

Japanese Treat and Extend study of Aflibercept in Neovascular age-related Macular Degeneration (ALTAIR)

Bayer Identifier:

17668

ClinicalTrials.gov Identifier:

NCT02305238

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
288
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mito, Japan, 310-0845

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 457-8510

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 545-8586

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 001-0016

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 232-0024

Status
Completed
 
Locations

Investigative Site

Hirakata, Japan, 573-1191

Status
Completed
 
Locations

Investigative Site

Ube, Japan, 755-8505

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 814-0180

Status
Completed
 
Locations

Investigative Site

Miyakonojo, Japan, 885-0051

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-0023

Status
Completed
 
Locations

Investigative Site

Sakura, Japan, 285-8741

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 467-8602

Status
Completed
 
Locations

Investigative Site

Toyoake, Japan, 470-1192

Status
Completed
 
Locations

Investigative Site

Otsu, Japan, 520-2192

Status
Completed
 
Locations

Investigative Site

Moriguchi, Japan, 570-8507

Status
Completed
 
Locations

Investigative Site

Miyazaki, Japan, 889-1692

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Investigative Site

Morioka, Japan, 020-8505

Status
Completed
 
Locations

Investigative Site

Koriyama, Japan, 963-8052

Status
Completed
 
Locations

Investigative Site

Kure, Japan, 737-0029

Status
Completed
 
Locations

Investigative Site

Nankoku, Japan, 783-8505

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Investigative Site

Hachioji, Japan, 193-0998

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 065-0031

Status
Completed
 
Locations

Investigative Site

Inashiki-gun, Japan, 300-0395

Status
Completed
 
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Chiyoda-ku, Japan, 101-8309

Status
Completed
 
Locations

Investigative Site

Chuo, Japan, 409-3898

Status
Completed
 
Locations

Investigative Site

Ichinomiya, Japan, 491-8551

Status
Completed
 
Locations

Investigative Site

Takatsuki, Japan, 569-1096

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 533-0024

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Investigative Site

Taito-ku, Japan, 111-0051

Status
Completed
 
Locations

Investigative Site

Chuoku, Japan, 104-8560

Status
Completed
 
Locations

Investigative Site

Shimonoseki, Japan, 750-0061

Status
Completed
 
Locations

Investigative Site

Asahi, Japan, 289-2511

Status
Completed
 
Locations

Investigative Site

Iida, Japan, 395-8502

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 060-0010

Status
Completed
 
Locations

Investigative Site

Matsumoto, Japan, 390-8621

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 700-8558

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 

Trial Design