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NCT04976777 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
A Phase 3 study of Macular Edema, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 7
- Study locations
NCT04976777 is a Phase 3 study of Macular Edema that has completed, run by AbbVie. The registered enrollment target is 54 participants, below the 176-participant average among 14 other Macular Edema trials with a reported enrollment target (69% lower). The trial reports 7 study locations across 5 states.
The verdict
NCT04976777, a Phase 3 study of Macular Edema, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 7
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DEVICE Updated DEX PS DDS Applicator
- DEVICE Approved DEX PS DDS Applicator
Study Locations (7)
Texas
- Retina Research Institute of Texas /ID# 231420 - Abilene
- Texas Retina Associates /ID# 231305 - Arlington
- North Texas Retina Consultants /ID# 241013 - Willow Park
California
- Global Research Management /ID# 238944 - Glendale
Massachusetts
- Advanced Eye Centers Inc /ID# 233429 - North Dartmouth
Missouri
- Discover Vision Centers /ID# 239366 - Independence
South Carolina
- Charleston Neurosciences Institute /ID# 238521 - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2022-02-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04976777
The ClinicalTrials.gov registry entry for NCT04976777 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 14 other Macular Edema trials with a reported enrollment target (69% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT04976777 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Texas, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04976777 about?
NCT04976777 is a clinical study titled "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...
What is the current status of trial NCT04976777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2021-10-12. Estimated completion is 2022-02-09.
What conditions does trial NCT04976777 study?
This clinical trial studies the following conditions: Macular Edema.
What interventions are being tested in trial NCT04976777?
The interventions under investigation include: Dexamethasone (DRUG), Updated DEX PS DDS Applicator (DEVICE), Approved DEX PS DDS Applicator (DEVICE).
Who is sponsoring clinical trial NCT04976777?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04976777 being conducted?
This trial has 7 study locations across California, Massachusetts, Missouri, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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