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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02745119 |
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Date of registration:
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18/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
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Scientific title:
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A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study |
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Date of first enrolment:
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July 21, 2016 |
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Target sample size:
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994 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02745119 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Canada
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Denmark
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France
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Germany
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Hungary
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Italy
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Mexico
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Netherlands
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Peru
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Poland
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Portugal
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Russian Federation
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Slovakia
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with
completion of treatment and the Week 96 visit
- Agreement to remain abstinent or use a reliable form of contraception among all men
and among women of child-bearing potential
Exclusion Criteria:
- Concurrent ocular conditions that contraindicate use of lampalizumab or might affect
interpretation of study results or that might increase the risk of treatment
complications
- Concurrent disease, metabolic dysfunction, or physical or laboratory finding that
contraindicates use of lampalizumab or might affect interpretation of study results or
that might increase the risk of treatment complications
- Increased risk of infection
- Pregnancy or lactation
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Geographic Atrophy
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Intervention(s)
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Drug: Lampalizumab
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Primary Outcome(s)
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Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
[Time Frame: Up to approximately one year]
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Percentage of Participants With Anti-Lampalizumab Antibodies
[Time Frame: Week 48]
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Percentage of Participants With Ocular Adverse Events (AEs) by Severity
[Time Frame: Up to approximately one year]
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Secondary ID(s)
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GX30191
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2016-000423-13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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