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A Study of RO7663498 for Diabetic Retinopathy

This study is looking at a new treatment called RO7663498 for people with diabetic retinopathy (DR), an eye condition caused by diabetes. The main goal is to see how safe RO7663498 is when injected into the eye (intravitreal administration) and how well your body handles it. Researchers will be watching for any side effects in your eyes or body for up to 20 weeks. You might be able to join if you have Type 1 or Type 2 diabetes and your vision in the study eye is at a certain level. About 30 people are expected to participate in this study.

Study design
This is an interventional study, meaning participants will receive the RO7663498 treatment. It is planned to include about 30 participants.
What's involved
Participants will receive RO7663498 injections according to the study schedule. You will have eye exams and other assessments for up to 20 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 20 weeks to monitor for side effects and other changes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07588100

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hoffmann-La Roche
~30 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:RO7663498

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Ocular Adverse Events (AEs)
Measured over Up to Week 20
+2 more outcomes measured

Conditions

Diabetic Retinopathy

Explore related trials

Non-Proliferative Diabetic Retinopathy

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of Participants With Ocular Adverse Events (AEs)Up to Week 20
  • Percentage of Participants With Systemic (non-ocular) AEsUp to Week 20
  • Number of Abnormalities Recorded in Standard Ophthalmological AssessmentsUp to Week 20