A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
Public ClinicalTrials.gov record NCT04976777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of an Updated Dexamethasone Posterior Segment Drug Delivery System Applicator in Participants With Macular Edema Due to Retinal Diseases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04976777
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Interventions
- Updated DEX PS DDS Applicator Device
- Approved DEX PS DDS Applicator Device
- Dexamethasone Drug
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2021
- Primary completion
- Feb 8, 2022
- Completion
- Feb 8, 2022
- Last update posted
- Feb 27, 2023
2021 – 2022
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Global Research Management /ID# 238944 | Glendale | California | 91204-2500 | — |
| Advanced Eye Centers Inc /ID# 233429 | North Dartmouth | Massachusetts | 02747-1278 | — |
| Discover Vision Centers /ID# 239366 | Independence | Missouri | 64055-6974 | — |
| Charleston Neurosciences Institute /ID# 238521 | Charleston | South Carolina | 29414-5896 | — |
| Retina Research Institute of Texas /ID# 231420 | Abilene | Texas | 79606-1224 | — |
| Texas Retina Associates /ID# 231305 | Arlington | Texas | 76012 | — |
| North Texas Retina Consultants /ID# 241013 | Willow Park | Texas | 76087-9133 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04976777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04976777 live on ClinicalTrials.gov.