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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02745119
Registration number
NCT02745119
Ethics application status
Date submitted
18/04/2016
Date registered
20/04/2016
Date last updated
6/03/2019
Titles & IDs
Public title
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
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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Secondary ID [1]
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2016-000423-13
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Secondary ID [2]
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GX30191
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy
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Condition category
Condition code
Eye
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0
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Diseases / disorders of the eye
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Other
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lampalizumab
Experimental: Lampalizumab Every 4 Weeks - Participants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.
Experimental: Lampalizumab Every 6 Weeks - Participants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.
Treatment: Drugs: Lampalizumab
Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Ocular Adverse Events (AEs) by Severity
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Assessment method [1]
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An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
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Timepoint [1]
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Up to approximately one year
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Primary outcome [2]
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Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
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Assessment method [2]
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An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
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Timepoint [2]
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Up to approximately one year
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Primary outcome [3]
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Percentage of Participants With Anti-Lampalizumab Antibodies
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Assessment method [3]
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The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.
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Timepoint [3]
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Week 48
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/01/2018
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Sample size
Target
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Accrual to date
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Final
994
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Eyeclinic Albury Wodonga - Albury
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Marsden Eye Research Centre - Parramatta
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Save Sight Institute - Sydney
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Sydney West Retina - Westmead
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Vision Eye Institute Eastern - Box Hill
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Royal Victorian Eye and Ear Hospital - East Melbourne
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2640 - Albury
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2150 - Parramatta
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2000 - Sydney
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2145 - Westmead
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3002 - East Melbourne
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Funding & Sponsors
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Name
Hoffmann-La Roche
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Summary
Brief summary
This multicenter open-label extension study is designed to evaluate the safety and
tolerability of lampalizumab intravitreal injections in participants with GA secondary to
age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176
(NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the
parent studies who received investigational lampalizumab, as well as lampalizumab-naive
participants exposed to sham comparator. All participants will receive open-label
lampalizumab in the present study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02745119
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Contacts
Principal investigator
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02745119
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