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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976777
• Other study ID #: 1491-801-007
• Status: Completed
• Phase: Phase 3
• Start date: October 12, 2021
• Est. completion date: February 9, 2022

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Device:
• Updated DEX PS DDS Applicator
Intravitreal Administration
• Approved DEX PS DDS Applicator
Intravitreal administration

Drug:
• Dexamethasone
Dexamethasone 0.7 mg in a solid polymer drug delivery system

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas /ID# 231420	Abilene	Texas
United States	Texas Retina Associates /ID# 231305	Arlington	Texas
United States	Charleston Neurosciences Institute /ID# 238521	Charleston	South Carolina
United States	Global Research Management /ID# 238944	Glendale	California
United States	Discover Vision Centers /ID# 239366	Independence	Missouri
United States	Advanced Eye Centers Inc /ID# 233429	North Dartmouth	Massachusetts
United States	North Texas Retina Consultants /ID# 241013	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance	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.	Day 1 After Study Drug Administration
Primary	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

External Links

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