N/A
Completed N=141
Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)
Source: ClinicalTrials.gov NCT03889444 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Mean Number of OZURDEX® Implant Reinjections in the Study Eye — 3.0 number of injections
Summary
A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1 January 2015 to 1 September 2017.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of OZURDEX® Implant Reinjections in the Study Eye |
3.0 | — |
| PRIMARY Time to OZURDEX® Reinjection |
5.7 | — |
| SECONDARY Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection |
3.4; 1.2; 0.5; 3.2; 3.0; 0.1 | — |
| SECONDARY Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection |
3.4; 3.7; 3.2; -1.4; 0.5; 3.5 | — |
| SECONDARY Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection |
-88.3; -63.9; -70.4; -51.6; -84.0; -60.6 | — |
| SECONDARY Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection |
-88.3; -81.6; -102.4; -124.1; -115.7; -147.7 | — |
| SECONDARY Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs) |
18.4 | — |
Eligibility Criteria
Inclusion Criteria
- Participant received at least two Ozurdex® implants in the study eye to treat visual impairment due to DME
- First Ozurdex® implant injection occurred after 1 January 2015
- Participant was followed-up at the site for at least 12 months after the first Ozurdex® implant in the study eye
Exclusion Criteria
- Participant received Ozurdex® implants as part or during a clinical study
Data sourced from ClinicalTrials.gov (NCT03889444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.