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Monoclonal Antibodies
RO7303359 for Age-Related Macular Degeneration
Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called RO7303359, which is injected directly into the eye. It aims to help people with vision loss due to age-related macular degeneration. The study will check if the drug is safe and how it works in the body.
Eligible Conditions
- Age-Related Macular Degeneration (AMD)
- Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Aqueous humor concentration of RO7303359
Concentration of serum anti drug antibodies (ADAs) at baseline and incidence of serum ADAs
Proportion of participants with anti-drug-antibodies (ADA) to RO7303359
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Single Ascending Dose StageExperimental Treatment1 Intervention
Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).
Group II: Optional cohort FExperimental Treatment1 Intervention
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
Group III: Optional Cohort EExperimental Treatment1 Intervention
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
Group IV: Expansion Cohort StageExperimental Treatment1 Intervention
Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7303359
2020
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,095,506 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,356 Total Patients Enrolled
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