A Multicenter, Patient-Masked, Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019079-32-PT

Enrollment

290

Registered

2010-04-05

Start date

2010-05-19

Completion date

Unknown

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who participated in a previous intravitreal Brimo PS DDS study, including 190342-028D (Retinitis pigmentosa) and 190342-032D (Geographic Atrophy from Age-related Macular Degeneration).

Interventions

Product Name: Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator System Product Code: 9715X Pharmaceutical Form: Implant INN or Proposed INN: Brimonidine Tartrate CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. Written informed consent has been obtained 3. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained 4. Written Data Protection Consent (European sites only) has been obtained 5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable 6. Willing to follow instructions and likely to complete all required visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: n/a

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the biodegradation and related safety profile of the intravitreal Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS®) Implant;Secondary Objective: n/a;Primary end point(s): Safety Measures: • Adverse events • Vital signs (blood pressure, pulse, respiration) • Manifest refraction and BCVA by ETDRS • Biomicroscopic examination • IOP • Indirect ophthalmoscopic examination • DDS® residual assessment • Photograph of the implant if visible	—

Measure

Time frame

Main Objective: To evaluate the biodegradation and related safety profile of the intravitreal Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS®) Implant;Secondary Objective: n/a;Primary end point(s): Safety Measures: • Adverse events • Vital signs (blood pressure, pulse, respiration) • Manifest refraction and BCVA by ETDRS • Biomicroscopic examination • IOP • Indirect ophthalmoscopic examination • DDS® residual assessment • Photograph of the implant if visible

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Countries

Czech Republic, Germany, Italy, Portugal, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026