Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant - Trial NCT05978622
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.
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Study Focus
Observational
Sponsor & Location
AbbVie
Timeline & Enrollment
N/A
Sep 12, 2023
Mar 31, 2026
Primary Outcome
Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation
Summary
The dexamethasone 700 ฮผg 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
Data Source
ClinicalTrials.gov
NCT05978622
Non-Device Trial