Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration

Phase 4

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: Aflibercept

• Registration Number: NCT01824225
• Lead Sponsor: Nihon University

Brief Summary

Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-31
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-04
• Primary Completion: 2014-03
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of age-related macular degeneration

Exclusion Criteria

• Any treatment before intravitreal Aflibercept for age-related macular degeneration.
• Visual acuity above 0.1 in decimal visual acuity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRN injection of aflibercept	Aflibercept	Intravitreal aflibercept
Two months injection of aflibercept	Aflibercept	Intravitreal afilibercept

Primary Outcome Measures

Name	Time	Method
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept	one year

Trial Locations

Locations (1)

Surugadai Nihon university hospital; 🇯🇵 Chiyoda-ku, Tokyo, Japan