Trial Outcomes & Findings for 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 NCT04976777)
NCT ID: NCT04976777
Last Updated: 2023-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
Up to 7 Days After Study Drug Administration
Results posted on
2023-02-28
Participant Flow
Participants took part at 7 investigational sites in the United States from 12 October 2021 to 7 February 2022.
Participant milestones
| Measure |
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg
DEX 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
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
18
|
|
Overall Study
COMPLETED
|
35
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg
DEX 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
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
|
|---|---|---|
|
Overall Study
COVID-19 Infection
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
Baseline characteristics by cohort
| Measure |
Updated DEX PS DDS 0.7 mg
n=36 Participants
DEX 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
n=18 Participants
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 11.94 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 Days After Study Drug AdministrationPopulation: SAS included of all participants who received DEX PS DDS Implant.
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.
Outcome measures
| Measure |
Updated DEX PS DDS 0.7 mg
n=36 Participants
DEX 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
n=18 Participants
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
|
|---|---|---|
|
Number of Participants Experiencing at Least One Adverse Events (AEs)
|
13 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 After Study Drug AdministrationThe 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.
Outcome measures
Outcome data not reported
Adverse Events
Updated DEX PS DDS 0.7 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Approved DEX PS DDS 0.7 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Updated DEX PS DDS 0.7 mg
n=36 participants at risk
DEX 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
n=18 participants at risk
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
|
|---|---|---|
|
Infections and infestations
COVID-19 PNEUMONIA
|
2.8%
1/36 • Number of events 1 • Up to 7 Days After Study Drug Administration
|
0.00%
0/18 • Up to 7 Days After Study Drug Administration
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
2.8%
1/36 • Number of events 1 • Up to 7 Days After Study Drug Administration
|
0.00%
0/18 • Up to 7 Days After Study Drug Administration
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.8%
1/36 • Number of events 1 • Up to 7 Days After Study Drug Administration
|
0.00%
0/18 • Up to 7 Days After Study Drug Administration
|
Other adverse events
| Measure |
Updated DEX PS DDS 0.7 mg
n=36 participants at risk
DEX 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
n=18 participants at risk
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
|
|---|---|---|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
27.8%
10/36 • Number of events 10 • Up to 7 Days After Study Drug Administration
|
38.9%
7/18 • Number of events 7 • Up to 7 Days After Study Drug Administration
|
|
Infections and infestations
COVID-19
|
0.00%
0/36 • Up to 7 Days After Study Drug Administration
|
5.6%
1/18 • Number of events 1 • Up to 7 Days After Study Drug Administration
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
5.6%
2/36 • Number of events 2 • Up to 7 Days After Study Drug Administration
|
0.00%
0/18 • Up to 7 Days After Study Drug Administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER