A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy (CENOTE)

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

This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Drug: RO7663498

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BP46156 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General Inclusion Criteria

• 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.

Exclusion Criteria:

General Exclusion Criteria:

• Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.
• History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.

Ocular Exclusion Criteria for the Study Eye

• Center-involved Diabetic Macular Edema (DME)
• Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below.
• Vitreoretinal surgery/pars plana vitrectomy.
• Any history of glaucoma surgery or planned glaucoma surgery during the study.
• Uncontrolled glaucoma
• Anterior segment neovascularization.
• Vitreous or preretinal hemorrhage.
• Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion.
• Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature [SUN] criteria > 0 or National Eye Institute [NEI] vitreous haze grading > 0) or any history of IOI.
• Aphakia or previous violation of the posterior capsule in the study eye

Ocular Exclusion Criteria for the Non-study Eye

• BCVA < 38 letters

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive RO7663498.	Drug: RO7663498; Participants will receive RO7663498 as per the schedule defined in the protocol.
Experimental: Cohort 2; Participants will receive RO7663498.	Drug: RO7663498; Participants will receive RO7663498 as per the schedule defined in the protocol.
Experimental: Cohort 3; Participants will receive RO7663498.	Drug: RO7663498; Participants will receive RO7663498 as per the schedule defined in the protocol.
Experimental: Cohort 4; Participants will receive RO7663498.	Drug: RO7663498; Participants will receive RO7663498 as per the schedule defined in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Ocular Adverse Events (AEs)	Up to Week 20
Percentage of Participants With Systemic (non-ocular) AEs	Up to Week 20
Number of Abnormalities Recorded in Standard Ophthalmological Assessments	Up to Week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Aqueous Humor (AH) Concentrations of RO7663498	Up to Week 12
Serum Concentrations of RO7663498	Up to Week 20

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: BP46156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No