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NCT05966753 Clinical Trial

Describing Patient With DME, Their Patient Journey and Disease Progression

Diabetic Macular Edema Clinical Trial

Official title:
Observational Study on the Management, and Progression of Patients With Diabetic Macula Edema (DME)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05966753
Other study ID # 1485-0016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2023
Est. completion date December 31, 2023

Study information
Verified date January 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to characterize patients with diabetic macular edema (DME), their progression, the treatment received and associate the functional and physiological outcomes related to the treatment.

Recruitment information / eligibility
Status Completed
Enrollment 182000
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All patients =18 years, with a DME diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023) Exclusion Criteria: Patients without the information of laterality will be excluded.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States CorEvitas HQ Waltham Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in visual acuity From January 2015 to April 2023
Primary Progression to DME in the fellow eye From January 2015 to April 2023
Primary Initial treatment of DME From January 2015 to April 2023
Primary Central retinal thickness (CRT) From January 2015 to April 2023
See also
  Status Clinical Trial Phase
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Completed NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) Phase 3
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Completed NCT02000102 - Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab N/A
Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A

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