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Monoclonal Antibodies

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to 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 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

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 more

Awards & 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
2,459 Previous Clinical Trials
1,098,188 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
896,208 Total Patients Enrolled
~7 spots leftby Dec 2025
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