A Multicenter, Non-Randomized, Open-Label, Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
⁃ Ocular Inclusion Criteria for the Study Eye
• BCVA score at screening of \>= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
• Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)
• Collection of \>= 90 micro liter (μL) AH deemed feasible and safe by the investigator.
Locations
United States
California
Global Research Management
RECRUITING
Glendale
Contact Information
Primary
Reference Study ID Number: BP46156 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Backup
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-06-22
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 30
Treatments
Experimental: Cohort 1
Participants will receive RO7663498.
Experimental: Cohort 2
Participants will receive RO7663498.
Experimental: Cohort 3
Participants will receive RO7663498.
Experimental: Cohort 4
Participants will receive RO7663498.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche