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

Roche

Status and phase: Enrolling; Phase 1

Conditions: Diabetic Retinopathy

Treatments: Drug: RO7663498

Study type: Interventional

Funder types: Industry

Identifiers

NCT07588100

BP46156

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Participants will receive RO7663498.

Treatment:

Drug: RO7663498

Cohort 2

Experimental group

Description:

Participants will receive RO7663498.

Treatment:

Drug: RO7663498

Cohort 3

Experimental group

Description:

Participants will receive RO7663498.

Treatment:

Drug: RO7663498

Cohort 4

Experimental group

Description:

Participants will receive RO7663498.

Treatment:

Drug: RO7663498