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NCT Number: NCT07588100

A 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Global Research Management

Glendale, California, 91204, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7663498

Drug

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

Primary outcomes

  1. Percentage of Participants With Ocular Adverse Events (AEs)

    Time frame: Up to Week 20

  2. Percentage of Participants With Systemic (non-ocular) AEs

    Time frame: Up to Week 20

  3. Number of Abnormalities Recorded in Standard Ophthalmological Assessments

    Time frame: Up to Week 20

Secondary outcomes

  1. Aqueous Humor (AH) Concentrations of RO7663498

    Time frame: Up to Week 12

  2. Serum Concentrations of RO7663498

    Time frame: Up to Week 20

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: CENOTE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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