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Brimo PS DDS

Phase 2

Patients Who Participated in an Intravitreal Brimo PS DDS® Study | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Feb 20, 2015

Success Probability

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Market & Valuation

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Trial Design

SHAM_CONTROLLED
Total Trials1
Total Enrollment215

FDA Designations

No designations recorded

Clinical trial landscape

Brimo PS DDS · 1 trial · 1 indication

Phase 2 1
NCT01080209Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery SystemPatients Who Participated in an Intravitreal Brimo PS DDS® Study
COMPLETED215 Analytics
PHASE2COMPLETED
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Patients Who Participated in an Intravitreal Brimo PS DDS® StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With No Visible Implants in the Study Eye
Month 36

Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.

Secondary Endpoints

Number of Patients With Vision Loss in the Study Eye
Baseline of Parent Study, Month 36
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Brimo PS DDS® 400 μg (2 implants)EXPERIMENTALPatients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Brimo PS DDS® 400 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
Brimo PS DDS® 200 μg (2 implants)EXPERIMENTALPatients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
Brimo PS DDS® 200 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
Brimo PS DDS® 100 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
Brimo PS DDS® 50 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
ShamSHAM_COMPARATORPatients who received sham in a previous study.

Interventions

NameTypeDescription
Brimo PS DDS®DRUGPatients who received Brimo PS DDS® intravitreal implant in a previous study.
ShamOTHERPatients who recieved sham in a previous study.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason * Applicable studies: Prev...

Countries:United StatesAustraliaCzechiaFranceGermanyIndiaIsraelItalyPhilippinesPortugalSouth KoreaUnited Kingdom
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Frequently asked questions about Brimo PS DDS

What is Brimo PS DDS used for?

Brimo PS DDS is an investigational small molecule being studied in patients who participated in an intravitreal Brimo PS DDS study. It is in Phase 2 clinical development for this ophthalmology indication. The drug is not approved and remains under clinical investigation.

What does Brimo PS DDS target?

Brimo PS DDS is a small molecule developed by AbbVie Inc. for use in ophthalmology. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here.

Who makes Brimo PS DDS?

Brimo PS DDS is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 2 clinical development for an ophthalmology indication.

What phase is Brimo PS DDS in?

Brimo PS DDS is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is Brimo PS DDS in?

Brimo PS DDS has one completed Phase 2 trial, NCT01080209, titled "Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System." The trial enrolled 215 participants across multiple countries, including the United States, Australia, and several European and Asian nations.

Is Brimo PS DDS the same as Brimonidine Tartrate Posterior Segment Drug Delivery System?

Brimo PS DDS is also known as the Brimonidine Tartrate Posterior Segment Drug Delivery System, as reflected in the title of its clinical trial NCT01080209. The drug is being studied for use in patients who previously participated in an intravitreal Brimo PS DDS study.