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

• Sponsor: University of Athens (Other)
• Overall Status: Completed
• CT.gov ID: NCT05683912
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 39.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Aflibercept

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece: The ADMIRE Study
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Sep 1, 2021
• Actual Study Completion Date: Dec 15, 2022

Outcome Measures

Primary Outcome Measures

1. Change in best-corrected visual acuity [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Athens	Athens		Greece	12462

Sponsors and Collaborators

• University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Irini Chatziralli, Assistant Professor in Ophthalmology, University of Athens
• ClinicalTrials.gov Identifier: NCT05683912
• Other Study ID Numbers: 698/2019
• First Posted: Jan 13, 2023
• Last Update Posted: Jan 13, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Edema; Aflibercept

Study Results

No Results Posted as of Jan 13, 2023