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NCT05472376 Clinical Trial

Real-Life Study in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:
Real-World Outcomes of Anti-VEGF Treatment for Diabetic Macular Edema in Turkey: A Multicenter Retrospective Study, MARMASIA Study Group

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05472376
Other study ID # MARMASIA Study Group
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 29, 2020
Est. completion date June 15, 2022

Study information
Verified date July 2022
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 854
Est. completion date June 15, 2022
Est. primary completion date March 17, 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Retrospective study
Retrospective study

Locations
Country Name City State
Turkey Marmara University School of Medicine Istanbul
Turkey Memorial Sisli Hospital Istanbul
Turkey University Health Sciences, Kartal Dr. Lütfi Kirdar Training and Research Hospital Istanbul
Turkey University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital Istanbul
Turkey University of Health Sciences, Haydarpasa Numune Training and Research Hospital Istanbul
Turkey University of Health Sciences, Sisli Etfal Training and Research Hospital Istanbul
Turkey University of Health Sciences, Ümraniye Training and Research Hospital Istanbul
Turkey Kocaeli University School of Medicine Kocaeli None Selected
Turkey University of Health Sciences, Derince Training and Research Hospital Kocaeli
Turkey Sakarya University School of Medicine Sakarya

Sponsors (1)
Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visit and Intravitreal Injection Numbers 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. First year
See also
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