Clinical trial NCT03889444: 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)
Official title: Drug Utilization Study in Patients Receiving Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From a public health and market access perspective, the present study population constitutes a broader real-world participant population than that reflected in clinical trials. The present study design does not make any conclusions on causal relationships, but can rather explore real-world Ozurdex® drug utilization patterns, effectiveness and safety. It is expected that the results from this study may be generalizable to the overall population presenting with DME and treated with Ozurdex® in Germany and Switzerland. Participants may contribute at most one eye into the study. If both eyes meet the inclusion criteria, the eye that received the most Ozurdex® injections will be chosen as the study eye.

Brief 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.


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

Primary outcomes:
measure: Mean Number of OZURDEX® Implant Reinjections in the Study Eye
timeFrame: Up to 44 months
measure: Time to OZURDEX® Reinjection
timeFrame: Up to 44 months
Secondary outcomes:
measure: 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
timeFrame: Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection
measure: 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
timeFrame: Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection
measure: 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
timeFrame: Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection
measure: 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
timeFrame: Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection
measure: Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs)
timeFrame: Up to 44 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Clinical Trials Registry Team
state: California
Study officials:
affiliation: Allergan
name: Paramjit Singh
role: STUDY_DIRECTOR
References: