Overview
This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each.
To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.
Principal investigator
Eligibility criteria
Inclusion Criteria:
1. Signed informed consent in the qualifying study.
2. Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures.
3. Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study.
4. Meets all the eligibility criteria in the qualifying study
Exclusion Criteria: 1. Patients not randomized and not receiving study assigned treatment in a qualifying study. 2. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents. 3. Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements
Exclusion Criteria: 1. Patients not randomized and not receiving study assigned treatment in a qualifying study. 2. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents. 3. Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements
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