Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece (ADMIRE)

December 27, 2022 updated by: Irini Chatziralli, University of Athens

Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece: The ADMIRE Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in best-corrected visual acuity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Estimate)

January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 698/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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