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

Hoffmann-La Roche · NCT07588100

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
30
US sites recruiting
4
Study start
June 18, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: RO7663498

Conditions: Diabetic Retinopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments. · 888-662-6728 (U.S. Only) · global-roche-genentech-trials@gene.com
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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A Study to Investigate the Safety, Tolerability, and… (NCT07588100) | Bored Studies