← Back to Search

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

Study Summary

This trial will investigate the safety and tolerability of a new drug for age-related macular degeneration, given as a single injection into the eye.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Percentage of Participants With Adverse Events Leading to Study Discontinuation
Percentage of Participants With Adverse Events of Special Interest (AESIs)
+4 more
Secondary outcome measures
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

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
2,431 Previous Clinical Trials
1,090,031 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,903 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this current clinical investigation?

"This experiment necessitates the participation of 63 subjects who meet the specified criteria. Those wishing to participate can do so at University Retina and Macula Associates, PC in Oak Forest, Illinois or Retina Vitreous Associates of Florida in Saint Petersburg, Florida."

Answered by AI

Are there any available openings for participants in this research endeavor?

"Affirmative. Evidenced by clinicaltrials.gov, this trial was first advertised on December 8th 2020 and is still presently seeking participants. A total of 63 individuals are required to be recruited from 17 centres."

Answered by AI

Has the Food and Drug Administration issued authorization of RO7303359?

"Our safety assessment of RO7303359 is a 1 due to its Phase 1 status, meaning there are only preliminary data available regarding the medication's efficacy and security."

Answered by AI

To what extent is this study being administered throughout various locations?

"This medical experiment is currently enrolling participants at 17 trial sites, including Oak Forest, Saint Petersburg and Austin. To reduce the burden of travel on volunteers participating in this study, it is advised to select a site nearby."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Florida
How old are they?
65+
What site did they apply to?
Colorado Retina Associates, PC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

IU am desperate to retain the level of vison I have. I haven’t tried any drugs and my vision is getting worse and I would like to get something to at least slow the progression.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04615325.
~9 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top