NCT05472376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
854

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

July 1, 2022

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (5)

3-month follow-up

Other: Retrospective study

6-month follow-up

Other: Retrospective study

12-month follow-up

Other: Retrospective study

24-month follow-up

Other: Retrospective study

36-month follow-up

Other: Retrospective study

Interventions

Retrospective study

12-month follow-up24-month follow-up3-month follow-up36-month follow-up6-month follow-up

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kocaeli University School of Medicine

Kocaeli, None Selected, 41001, Turkey (Türkiye)

Location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Memorial Şişli Hospital

Istanbul, Turkey (Türkiye)

Location

University Health Sciences, Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences, Haydarpaşa Numune Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences, Ümraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences, Şişli Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences, Derince Training and Research Hospital

Kocaeli, Turkey (Türkiye)

Location

Sakarya University School of Medicine

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 25, 2022

Study Start

November 29, 2020

Primary Completion

March 17, 2022

Study Completion

June 15, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations