NCT02126904

Brief Summary

The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

April 27, 2014

Last Update Submit

April 28, 2014

Conditions

The Injection Burden

Outcome Measures

Primary Outcomes (1)

  • Time to recurrence after induction phase

    Time frame depends on patients because recurrence time is different.

    More than 3 months from baseline

Study Arms (1)

IVR group

Drug: IVA group

Interventions

IVA groupDRUG
IVR group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All the patients were treated at Yokohama City University Medical Center between January 2012 and October 2013.

You may qualify if:

  • They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept.

You may not qualify if:

  • patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 27, 2014

First Posted

April 30, 2014

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

JP(1)