Macular Edema
Conditions
Keywords
Macular Edema, Dexamethasone, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Diabetic Macular Edema, Noninfectious Uveitis, Ozurdex, Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)
Brief 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.
Interventions
DEVICEUpdated DEX PS DDS Applicator
Intravitreal Administration
DEVICEApproved DEX PS DDS Applicator
Intravitreal administration
DRUGDexamethasone
Dexamethasone 0.7 mg in a solid polymer drug delivery system
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Participants with macular edema due to retinal vein occlusion (branch retinal vein occlusion or central retinal vein occlusion) or diabetic macular edema.
Exclusion criteria
\- Participants with ocular conditions in the study eye for which Dexamethasone Posterior Segment Drug Delivery System Implant is contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part at 7 investigational sites in the United States from 12 October 2021 to 7 February 2022.
Participants by arm
| Arm | Count |
|---|---|
| Updated 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. | 36 |
| 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. | 18 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Infection | 1 | 0 |
Baseline characteristics
| Characteristic | Approved DEX PS DDS 0.7 mg | Total | Updated DEX PS DDS 0.7 mg |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 11.94 | 65.9 years STANDARD_DEVIATION 11.25 | 66.2 years STANDARD_DEVIATION 11.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 44 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 49 Participants | 33 Participants |
| Sex: Female, Male Female | 11 Participants | 27 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 27 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 18 |
| other Total, other adverse events | 11 / 36 | 7 / 18 |
| serious Total, serious adverse events | 1 / 36 | 0 / 18 |
Outcome results
Primary
Number of Participants Experiencing at Least One Adverse Events (AEs)
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.
Time frame: Up to 7 Days After Study Drug Administration
Population: SAS included of all participants who received DEX PS DDS Implant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Updated DEX PS DDS 0.7 mg | Number of Participants Experiencing at Least One Adverse Events (AEs) | 13 Participants |
| Approved DEX PS DDS 0.7 mg | Number of Participants Experiencing at Least One Adverse Events (AEs) | 7 Participants |
Other Pre-specified
Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance
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.
Time frame: Day 1 After Study Drug Administration