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A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
NCT04976777 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04976777 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Texas, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04976777?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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