Real-Life Study in Diabetic Macular Edema

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Other: Retrospective study

• Registration Number: NCT05472376
• Lead Sponsor: Kocaeli University

Brief Summary

The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.

Detailed Description

The study included patients who were being observed in the retina departments of 8 tertiary hospitals in the Northern Marmara Region of Turkey (Istanbul's Asian Side, Kocaeli, and Sakarya). The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018 were reviewed.

Study Timeline

• Study Start: 2020-11-29
• Primary Completion: 2022-03-17
• Study Completion: 2022-06-15
• Status Verified: 2022-07
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Study First Posted: 2022-07-25
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 854

Inclusion Criteria

• Diabetic macular edema treated with intravitreal anti-VEGF injection
• Having at least 4 or more annual examination visits

Exclusion Criteria

• Phacoemulsification surgery in the last 1 month
• PRFK / grid / focal / micropulse in the last 4 months
• Previous intraocular surgery (excluding PPV and phacoemulsification)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
12-month follow-up	Retrospective study	-
36-month follow-up	Retrospective study	-
3-month follow-up	Retrospective study	-
6-month follow-up	Retrospective study	-
24-month follow-up	Retrospective study	-

Primary Outcome Measures

Name	Time	Method
Visit and Intravitreal Injection Numbers	First year	The primary outcomes were changes in best-corrected visual acuity and central macular thickness in the first year and frequency of visits and intravitreal anti-VEGF injections.

Trial Locations

Locations (10)

Kocaeli University School of Medicine; 🇹🇷 Kocaeli, None Selected, Turkey

University of Health Sciences, Haydarpaşa Numune Training and Research Hospital; 🇹🇷 İstanbul, Turkey

University of Health Sciences, Ümraniye Training and Research Hospital; 🇹🇷 İstanbul, Turkey

Marmara University School of Medicine; 🇹🇷 İstanbul, Turkey

Memorial Şişli Hospital; 🇹🇷 İstanbul, Turkey

University Health Sciences, Kartal Dr. Lütfi Kırdar Training and Research Hospital; 🇹🇷 İstanbul, Turkey

University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital; 🇹🇷 İstanbul, Turkey

University of Health Sciences, Şişli Etfal Training and Research Hospital; 🇹🇷 İstanbul, Turkey

University of Health Sciences, Derince Training and Research Hospital; 🇹🇷 Kocaeli, Turkey

Sakarya University School of Medicine; 🇹🇷 Sakarya, Turkey