Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

Clinicaltrials.gov Identifier:

nct02305238

Trial details

Trial date:

December 19, 2014 - December 22, 2016

Phase: 4

Birth sex

Age range

50 Years and Older

Accepts healthy volunteers

Condition(s) being studied:

Wet Macular Degeneration

What is the type of trial?

Interventional

What is the trial testing?

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

How many people are being enrolled?

288

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

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 locations

0 location(s)