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OpenTrials
Completed

NCT Number: NCT04976777

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Research Management /ID# 238944, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Updated DEX PS DDS Applicator

Device

Intravitreal Administration

Approved DEX PS DDS Applicator

Device

Intravitreal administration

Other names: OZURDEX®

Dexamethasone

Drug

Dexamethasone 0.7 mg in a solid polymer drug delivery system

Primary outcomes

  1. Number of Participants Experiencing at Least One Adverse Events (AEs)

    Time frame: Up to 7 Days After Study Drug Administration

    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.

Other outcomes

  1. Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance

    Time frame: Day 1 After Study Drug Administration

    The investigator evaluated whether the updated DEX PS DDS Applicator dispensed the DEX PS DDS implant in the vitreous cavity and performed as intended, using a treatment administration assessment form.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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