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

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).

Registration Number: EUCTR2010-019079-32-PT

Lead Sponsor: Allergan Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 290

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

n/a

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• Adverse events<br>• Vital signs (blood pressure, pulse, respiration)<br>• Manifest refraction and BCVA by ETDRS<br>• Biomicroscopic examination<br>• IOP<br>• Indirect ophthalmoscopic examination<br>• DDS® residual assessment<br>• Photograph of the implant if visible

Secondary Outcome Measures