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
NCT04976777, Phase 3, Completed, AbbVie; results first posted 2023-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina. Trials, record NCT04976777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04976777
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
- NCT number
- NCT04976777
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 54 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Macular Edema
- Interventions
- Updated DEX PS DDS Applicator, Approved DEX PS DDS Applicator, Dexamethasone
- First posted
- 2021-07-26
- Last updated
- 2023-02-28
- Results first posted
- 2023-02-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing at Least One Adverse Events (AEs) | Up to 7 Days After Study Drug Administration | 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. |
| Other | Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance | Day 1 After Study Drug Administration | The investigator evaluated whether the updated DEX PS DDS Applicator dispensed the DEX PS DDS implant in the vitreous cavity and performed as intended, using a treatment administration assessment form. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing at Least One Adverse Events (AEs) | Up to 7 Days After Study Drug Administration | SAS included of all participants who received DEX PS DDS Implant. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance | Day 1 After Study Drug Administration |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing at Least One Adverse Events (AEs) | Updated DEX PS DDS 0.7 mg | 13 | Participants | ||
| Number of Participants Experiencing at Least One Adverse Events (AEs) | Approved DEX PS DDS 0.7 mg | 7 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg | 36 | |
| Overall Study | STARTED | Approved DEX PS DDS 0.7 mg | 18 | |
| Overall Study | COMPLETED | Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg | 35 | |
| Overall Study | COMPLETED | Approved DEX PS DDS 0.7 mg | 18 | |
| Overall Study | NOT COMPLETED | Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg | 1 | |
| Overall Study | NOT COMPLETED | Approved DEX PS DDS 0.7 mg | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CONJUNCTIVAL HAEMORRHAGE | Eye disorders | Updated DEX PS DDS 0.7 mg | 10 | 36 | 10 |
| other | CONJUNCTIVAL HAEMORRHAGE | Eye disorders | Approved DEX PS DDS 0.7 mg | 7 | 18 | 7 |
| other | COVID-19 | Infections and infestations | Updated DEX PS DDS 0.7 mg | 0 | 36 | 0 |
| other | COVID-19 | Infections and infestations | Approved DEX PS DDS 0.7 mg | 1 | 18 | 1 |
| other | INTRAOCULAR PRESSURE INCREASED | Investigations | Updated DEX PS DDS 0.7 mg | 2 | 36 | 2 |
| other | INTRAOCULAR PRESSURE INCREASED | Investigations | Approved DEX PS DDS 0.7 mg | 0 | 18 | 0 |
| serious | COVID-19 PNEUMONIA | Infections and infestations | Updated DEX PS DDS 0.7 mg | 1 | 36 | 1 |
| serious | COVID-19 PNEUMONIA | Infections and infestations | Approved DEX PS DDS 0.7 mg | 0 | 18 | 0 |
| serious | CHRONIC KIDNEY DISEASE | Renal and urinary disorders | Updated DEX PS DDS 0.7 mg | 1 | 36 | 1 |
| serious | CHRONIC KIDNEY DISEASE | Renal and urinary disorders | Approved DEX PS DDS 0.7 mg | 0 | 18 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Updated DEX PS DDS 0.7 mg | 0 | 36 |
| Total, all-cause mortality | Approved DEX PS DDS 0.7 mg | 0 | 18 |
| Total, other adverse events | Updated DEX PS DDS 0.7 mg | 11 | 36 |
| Total, other adverse events | Approved DEX PS DDS 0.7 mg | 7 | 18 |
| Total, serious adverse events | Updated DEX PS DDS 0.7 mg | 1 | 36 |
| Total, serious adverse events | Approved DEX PS DDS 0.7 mg | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Updated DEX PS DDS 0.7 mg vs Approved DEX PS DDS 0.7 mg: Number of Participants Experiencing at Least One Adverse Events (AEs) | Trial comparisons |
| Updated DEX PS DDS 0.7 mg vs Approved DEX PS DDS 0.7 mg: deaths from any cause | Trial comparisons |
| Updated DEX PS DDS 0.7 mg vs Approved DEX PS DDS 0.7 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04976777
GET https://conductscience.org/api/trials/v1/NCT04976777/registered