A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
Evaluation of an Updated Dexamethasone Posterior Segment Drug Delivery System Applicator in Participants With Macular Edema Due to Retinal Diseases
1 other identifier
interventional
54
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2021
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedStudy Start
First participant enrolled
October 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2022
CompletedResults Posted
Study results publicly available
February 28, 2023
CompletedFebruary 28, 2023
February 1, 2023
4 months
July 15, 2021
February 3, 2023
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (1)
Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance
Day 1 After Study Drug Administration
Study Arms (2)
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg
EXPERIMENTALDEX 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
ACTIVE COMPARATORDEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
Interventions
Intravitreal Administration
Intravitreal administration
Dexamethasone 0.7 mg in a solid polymer drug delivery system
Eligibility Criteria
You may qualify if:
- \- Participants with macular edema due to retinal vein occlusion (branch retinal vein occlusion or central retinal vein occlusion) or diabetic macular edema.
You may not qualify if:
- \- Participants with ocular conditions in the study eye for which Dexamethasone Posterior Segment Drug Delivery System Implant is contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (7)
Global Research Management /ID# 238944
Glendale, California, 91204-2500, United States
Advanced Eye Centers Inc /ID# 233429
North Dartmouth, Massachusetts, 02747-1278, United States
Discover Vision Centers /ID# 239366
Independence, Missouri, 64055-6974, United States
Charleston Neurosciences Institute /ID# 238521
Charleston, South Carolina, 29414-5896, United States
Retina Research Institute of Texas /ID# 231420
Abilene, Texas, 79606-1224, United States
Texas Retina Associates /ID# 231305
Arlington, Texas, 76012, United States
North Texas Retina Consultants /ID# 241013
Willow Park, Texas, 76087-9133, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2021
First Posted
July 26, 2021
Study Start
October 12, 2021
Primary Completion
February 9, 2022
Study Completion
February 9, 2022
Last Updated
February 28, 2023
Results First Posted
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.