NCT05683912

Brief Summary

ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients and previously treated patients. Safety was evaluated by recording any patients-reported events.

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 all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

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

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 13, 2023

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

December 27, 2022

Last Update Submit

December 27, 2022

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Change in best-corrected visual acuity

    12 months

Interventions

AfliberceptDRUG

Intravitreal aflibercept as used in the routice clinical practice

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with DME treated with intravitreal aflibercept 2.0mg in routice clinical practice.

You may qualify if:

  • Patients with DM, able to give written informed consent Patients with DME\>320 μm, who need treatment

You may not qualify if:

  • Patients with other retinal diseases than DME Intraocular surgery within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Athens

Athens, 12462, Greece

Location

MeSH Terms

Interventions

aflibercept

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Ophthalmology

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 13, 2023

Study Start

September 1, 2019

Primary Completion

September 1, 2021

Study Completion

December 15, 2022

Last Updated

January 13, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)