Clinical trial 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
Official title: Evaluation of an Updated Dexamethasone Posterior Segment Drug Delivery System Applicator in Participants With Macular Edema Due to Retinal Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Keywords: 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)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Experiencing at Least One Adverse Events (AEs)
timeFrame: Up to 7 Days After Study Drug Administration
Secondary outcomes:
Other outcomes:
measure: Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance
timeFrame: Day 1 After Study Drug Administration
Locations:
city: Glendale
country: United States
facility: Global Research Management /ID# 238944
state: California
city: North Dartmouth
country: United States
facility: Advanced Eye Centers Inc /ID# 233429
state: Massachusetts
city: Independence
country: United States
facility: Discover Vision Centers /ID# 239366
state: Missouri
city: Charleston
country: United States
facility: Charleston Neurosciences Institute /ID# 238521
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institute of Texas /ID# 231420
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates /ID# 231305
state: Texas
city: Willow Park
country: United States
facility: North Texas Retina Consultants /ID# 241013
state: Texas
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: