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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Diabetic Macular Edema

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant diagnosed with DME in the study eye Study eye has received at least 3 and no more than 9 anti-VEGF injections in the 12 months prior to DEX-I initiation Study eye newly prescribed DEX-I. The prescribing decision lies with the physician and reflects their standard practice Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye Exclusion Criteria: Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract) History of ocular surgery within 60 days of Baseline in the study eye History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study eye Active ocular inflammation in either eye Study eyes that are aphakic with Posterior Capsule Rent (PCR), Anterior Chamber Intraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history of complicated cataract surgery with PCR Prior use of intravitreal corticosteroids in the study eye Patients with contraindications to DEX-I

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 |
| --- | --- |
| Dexamethasone Intravitreal Implant (DEX-I)<br>Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation | Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation | Baseline to 18 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Macular Edema, DME, Dexamethasone, Dexamethasone Intravitreal Implant, Ozurdex