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Phase 3 N=54 Randomized Treatment

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

Macular Edema

Enrolled (actual)
54
Serious AEs
1.8%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants Experiencing at Least One Adverse Events (AEs) — 13; 7 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Updated DEX PS DDS Applicator (Device); Approved DEX PS DDS Applicator (Device); Dexamethasone (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
AbbVie
Primary completion
Feb 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Experiencing at Least One Adverse Events (AEs)
13; 7

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04976777). 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.

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