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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

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