Studio multicentrico, in cieco, di estensione della sicurezza, atto a valutare la biodegradazione del sistema di rilascio del farmaco brimonidina tartrato nel segmento posteriore. - ND
- Conditions
- Patients who participated in a previous intravitreal Brimo PS DDS study, including 190342-032D (Geographic Atrophy from Age-related Macular Degeneration).MedDRA version: 9.1Level: LLTClassification code 10063947
- Registration Number
- EUCTR2010-019079-32-IT
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method