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

Phase 3

Completed

• Conditions: Macular Edema
• Interventions: Device: Updated DEX PS DDS Applicator; Device: Approved DEX PS DDS Applicator; Drug: Dexamethasone

• Registration Number: NCT04976777
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Study Start: 2021-10-12
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2023-02
• Results First Submitted: 2023-02-03
• Results First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Results First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg	Updated DEX PS DDS Applicator	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.
Approved DEX PS DDS 0.7 mg	Approved DEX PS DDS Applicator	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.
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg	Dexamethasone	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.
Approved DEX PS DDS 0.7 mg	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing at Least One Adverse Events (AEs)	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.

Trial Locations

Locations (7)

North Texas Retina Consultants /ID# 241013; 🇺🇸 Willow Park, Texas, United States

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

Retina Research Institute of Texas /ID# 231420; 🇺🇸 Abilene, Texas, United States

Discover Vision Centers /ID# 239366; 🇺🇸 Independence, Missouri, United States

Advanced Eye Centers Inc /ID# 233429; 🇺🇸 North Dartmouth, Massachusetts, United States

Charleston Neurosciences Institute /ID# 238521; 🇺🇸 Charleston, South Carolina, United States

Texas Retina Associates /ID# 231305; 🇺🇸 Arlington, Texas, United States