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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
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

Not provided

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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