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NCT05978622

Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

A Multi-country, Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant (DEX-I)
AbbVie·ClinicalTrials.govNot yet recruiting
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Study focus
Disease/Condition
Diabetic Macular Edema
Study type
Observational
Sponsor & location
Primary sponsor
AbbVie
Timeline & enrollment
Phase
N/A
Start date
Sep 12, 2023
End date
Mar 31, 2026
Enrollment
327 participants
Primary outcome

Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation

Summary

The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the
 retina over time. It is an approved drug for the treatment of DME. This study will assess
 adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular
 endothelial growth factor therapy that are treated with DEX-I in the routine clinical
 setting.
 
 Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled
 at approximately 40 sites in approximately 10 countries globally.
 
 Participants will be followed for 18 months post-DEX-I implantation according to the routine
 clinical practice of the prescribing centers. Only one eye per participant will be evaluated
 in the study.
 
 No additional burden for participants in this trial is expected.

ICD-10 classifications
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05978622
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05978622 through Pure Global AI's free database. This phase not specified trial is sponsored by AbbVie and is currently Not yet recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 327 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.