A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina

Study Overview
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Brief Summary
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The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator. This purpose of this study is to show that the updated DEX PS DDS Applicator works in adult participants with macular edema due to retinal diseases. The DEX PS DDS is approved for the treatment of macular edema. Participants will be placed into 1 of 2 groups, called treatment arms. Each group receives the same treatment drug delivered using different applicators. Around 54 adult participants with macular edema will be enrolled in the study in approximately 7-10 sites in the United States. Participants will receive a single intravitreal (into the eye) administration of DEX PS DDS implant using either the currently-approved DEX PS DDS Applicator or the the updated Applicator. The participants will be observed for a duration of 7 days, with the DEX PS DDS implant received on day 1 and follow-up through day 7. The updates being evaluated in this study are related to the DEX PS DDS Applicator only, with the safety and efficacy of the DEX PS DDS implant well characterized and the same as the currently marketed product. Participants will attend regular visits during the study at a hospital or clinic. The applicator function will be checked by medical assessment, checking for side effects, procedural complications and/or product complaints, and evaluating the administration procedure.

Official Title
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Evaluation of an Updated Dexamethasone Posterior Segment Drug Delivery System Applicator in Participants With Macular Edema Due to Retinal Diseases

Conditions
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Macular Edema

Intervention / Treatment
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* Device: Updated DEX PS DDS Applicator
* Device: Approved DEX PS DDS Applicator
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Participants with macular edema due to retinal vein occlusion (branch retinal vein occlusion or central retinal vein occlusion) or diabetic macular edema. Exclusion Criteria: - Participants with ocular conditions in the study eye for which Dexamethasone Posterior Segment Drug Delivery System Implant is contraindicated.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg<br>DEX PS DDS 0.7 mg implant was administered intravitreally into the study eye using updated applicator at Day 1 and followed until Day 7. | Device: Updated DEX PS DDS Applicator<br>* Intravitreal Administration<br>Drug: Dexamethasone<br>* Dexamethasone 0.7 mg in a solid polymer drug delivery system<br>|
| Active Comparator: Approved DEX PS DDS 0.7 mg<br>DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7. | Device: Approved DEX PS DDS Applicator<br>* Intravitreal administration<br>* Other names: OZURDEX®;Drug: Dexamethasone<br>* Dexamethasone 0.7 mg in a solid polymer drug delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing at Least One Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. | Up to 7 Days After Study Drug Administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Edema, Dexamethasone, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Diabetic Macular Edema, Noninfectious Uveitis, Ozurdex, Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)