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)

Study Overview
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Brief Summary
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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.

Official Title
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Drug Utilization Study in Patients Receiving Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Dexamethasone intravitreal implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OZURDEX®<br>Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice. | Drug: Dexamethasone intravitreal implant<br>* Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice.<br>* Other names: OZURDEX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of OZURDEX® Implant Reinjections in the Study Eye | Study eye was defined as the eye that received the most OZURDEX® injections. | Up to 44 months | 
| Time to OZURDEX® Reinjection | The time to reinjection is defined as the time in months from the date of one OZURDEX® injection to the subsequent OZURDEX® injection. | Up to 44 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive number indicates improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection. | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection | 
| 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 | BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive change from baseline indicates improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection. | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection | 
| 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 | OCT is measured in the study eye (defined as the eye that received the most OZURDEX® injections) prior to and following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection. | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection | 
| 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 | OCT is measured at Baseline and following each injection of OZURDEX® in the study eye (defined as the eye that received the most OZURDEX® injections . OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection. | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection | 
| Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. The adverse events of special interest include: Glaucoma, defined as damage to the optic nerve with progressive vision loss, Intraocular hypertension, defined as intra-ocular pressure (IOP) without meeting the criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation. | Up to 44 months |