Status:
COMPLETED
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Wet Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 Mac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT02305238
Start Date
December 19 2014
End Date
December 20 2017
Last Update
November 18 2023
Active Locations (41)
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1
Ichinomiya, Aichi-ken, Japan, 491-8551
2
Nagoya, Aichi-ken, Japan, 457-8510
3
Nagoya, Aichi-ken, Japan, 467-8602
4
Toyoake, Aichi-ken, Japan, 470-1192