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

NCT02305238 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2023-11-18

Study results available
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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.

Conditions

  • Wet Macular Degeneration

Interventions

DRUG

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

Aflibercept 2mg is intravitreally injected.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-19
Primary Completion
2016-12-22
Completion
2017-12-20
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305238 on ClinicalTrials.gov