RecruitingPhase 1NCT07588100

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

Sponsor

Hoffmann-La Roche

Enrollment

30 participants

Start Date

Jun 22, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Retinopathy

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
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 Criteria13

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.
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
BCVA < 38 letters