NCT01824225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

March 31, 2013

Last Update Submit

October 5, 2015

Conditions

Age-related Macular Degeneration

Keywords

afliberceptintravitreal injection

Outcome Measures

Primary Outcomes (1)

  • Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept

    one year

Study Arms (2)

PRN injection of aflibercept

ACTIVE COMPARATOR

Intravitreal aflibercept

Drug: Aflibercept

Two months injection of aflibercept

ACTIVE COMPARATOR

Intravitreal afilibercept

Drug: Aflibercept

Interventions

AfliberceptDRUG
PRN injection of afliberceptTwo months injection of aflibercept

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of age-related macular degeneration

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surugadai Nihon university hospital

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Mitsuko Yuzawa, M.D.

    Surugadai Nihon University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 31, 2013

First Posted

April 4, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

JP(1)