Real-Life Study in Diabetic Macular Edema

July 22, 2022 updated by: Levent Karabas, Kocaeli University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

854

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey
        • University of Health Sciences, Derince Training and Research Hospital
      • Sakarya, Turkey
        • Sakarya University School of Medicine
      • İstanbul, Turkey
        • Marmara University School of Medicine
      • İstanbul, Turkey
        • Memorial Sisli 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, Haydarpasa Numune Training and Research Hospital
      • İstanbul, Turkey
        • University of Health Sciences, Umraniye Training and Research Hospital
      • İstanbul, Turkey
        • University of Health Sciences, Şişli Etfal Training and Research Hospital
    • None Selected
      • Kocaeli, None Selected, Turkey, 41001
        • Kocaeli University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3-month follow-up
Other: Retrospective study
Retrospective study
6-month follow-up
Other: Retrospective study
Retrospective study
12-month follow-up
Other: Retrospective study
Retrospective study
24-month follow-up
Other: Retrospective study
Retrospective study
36-month follow-up
Other: Retrospective study
Retrospective study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visit and Intravitreal Injection Numbers
Time Frame: 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.
First year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2020

Primary Completion (Actual)

March 17, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARMASIA Study Group

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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