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NCT05683912 Clinical Trial

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

Diabetic Macular Edema Clinical Trial

— ADMIRE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05683912
Other study ID # 698/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 15, 2022

Study information
Verified date December 2022
Source University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 15, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aflibercept
Intravitreal aflibercept as used in the routice clinical practice

Locations
Country Name City State
Greece University of Athens Athens

Sponsors (1)
Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in best-corrected visual acuity 12 months
See also
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