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

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07588100

Acronym

CENOTE

Enrollment

Registered

2026-05-14

Start date

2026-06-18

Completion date

2028-01-20

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Brief summary

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

Interventions

DRUGRO7663498

Participants will receive RO7663498 as per the schedule defined in the protocol.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

United States

Contacts

CONTACTReference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments.

global-roche-genentech-trials@gene.com888-662-6728 (U.S. Only)

CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026