A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
Study Details
Study Description
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 a different treatment. 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.
There may be higher treatment burden for participants in this trial compared to their standard of care. 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 effect of the treatment will be checked by questionnaires, medical assessments, and checking for side effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Updated Dexamethasone Posterior Segment Drug Delivery System Dexamethasone Posterior Segment Drug Delivery System implant will be administered into the study eye during a single treatment. |
Drug: Updated Dexamethasone Posterior Segment Drug Delivery System
Intravitreal Administration
Other Names:
|
| Active Comparator: Approved Dexamethasone Posterior Segment Drug Delivery System Dexamethasone Posterior Segment Drug Delivery System implant will be administered into the study eye during a single treatment. |
Drug: Approved Dexamethasone Posterior Segment Drug Delivery System
Intravitreal administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Experiencing Adverse Events (AEs) [Up to 7 Days After Study Drug Administration]
An adverse event (AE) is defined as any untoward medical occurrence in a patient 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 Outcome Measures
- Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Updated Applicator Performance [Day 1 After Study Drug Administration]
The investigator will evaluate 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 questionnaire.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Global Research Management /ID# 238944 | Glendale | California | United States | 91204-2500 |
| 2 | Advanced Eye Centers Inc /ID# 233429 | North Dartmouth | Massachusetts | United States | 02747-1278 |
| 3 | Discover Vision Centers /ID# 239366 | Independence | Missouri | United States | 64055-6974 |
| 4 | Charleston Neurosciences Institute /ID# 238521 | Charleston | South Carolina | United States | 29414-5896 |
| 5 | Retina Research Institute of Texas /ID# 231420 | Abilene | Texas | United States | 79606-1224 |
| 6 | Texas Retina Associates /ID# 231305 | Arlington | Texas | United States | 76012 |
| 7 | North Texas Retina Consultants /ID# 241013 | Willow Park | Texas | United States | 76087-9133 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: ALLERGAN INC., Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1491-801-007