Recruiting
Phase 1

RO7663498

Sponsor:

Hoffmann-La Roche

Code:

NCT07588100

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RO7663498

Study Details

Brief summary:

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

Conditions

Diabetic Retinopathy

Study ID

NCT07588100

Start date

Jun 18, 2026

Status verified date

Sep, 2026

Completion date

Jan 20, 2028

Anticipated

Primary completion date

Jan 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Participants will receive RO7663498.

experimental: Cohort 2

Participants will receive RO7663498.

experimental: Cohort 3

Participants will receive RO7663498.

experimental: Cohort 4

Participants will receive RO7663498.

Interventions

RO7663498

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

Primary outcome measure

  • Percentage of Participants With Ocular Adverse Events (AEs) [ Time Frame: Up to Week 20 ]
  • Percentage of Participants With Systemic (non-ocular) AEs [ Time Frame: Up to Week 20 ]
  • Number of Abnormalities Recorded in Standard Ophthalmological Assessments [ Time Frame: Up to Week 20 ]

Central Contacts and Locations

Central contacts

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

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Global Research Management

Recruiting

Glendale, California, United States, 91204

University Retina and Macula Associates, PC

Recruiting

Oak Forest, Illinois, United States, 60452

Ohio State Havener Eye Institute;Ophthalmology Research

Recruiting

Columbus, Ohio, United States, 43212

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.