A Phase 1 interventional study of RO7171009 in Geographic Atrophy, sponsored by Genentech, Inc.. Completed at 13 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Treatment
Among 16 studies in Geographic Atrophy by Hoffmann-La Roche — 2 open to participants now, 2 under way, none of them phase 3. Geographic Atrophy · Hoffmann-La Roche.
Among the 16 studies in Geographic Atrophy by Hoffmann-La Roche, this one is the 12th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2017, is one of 4 in phase 1, and was the 10th registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
Browse Geographic Atrophy studies →2 of the 16 studies in Geographic Atrophy by Hoffmann-La Roche are open now, in 2 countries. Recruiting first, the newest first:
Genentech, Inc. · Sites in United States
Ages 50+
Genentech, Inc. · Sites in United States, Israel
Ages 50+
By country, each count listing its studies:
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
This study's enrollment of 28 is below the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Median enrollment 144 across the 14 interventional studies, 249 across the 2 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
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This study is registered under Genentech, Inc., one of the names counted as Hoffmann-La Roche. Under that name alone:
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Geographic Atrophy by Hoffmann-La Roche, from their registry updates:
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This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
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Exclusion Criteria:
Ocular Exclusion Criteria, Study Eye:
Ocular Exclusion Criteria (Both Eyes):
Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
Drug: RO7171009
Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.
Drug: RO7171009
Patients will receive RO7171009 via ITV injection.
Safety and Tolerability of the Study Drug: Rate of Adverse Events
Time frame: Through study completion or early study discontinuation (overall 12-20 weeks)
Serum Concentration of RO7171009
Time frame: Through study completion or early study discontinuation (overall 12-20 weeks)
Ran from Sep 2017 to primary completion in Nov 2018, 13 months.
Of 13 phase 1 interventional studies under Geographic Atrophy, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Galegenimab