Tests RO7663498 eye injections for diabetic retinopathy safety
Tests RO7663498 eye injections in adults with diabetic retinopathy.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
Key facts
- Where
- Columbus, Glendale, Oak Forest, and San Antonio, United StatesSee the 4 sites
- Phase
- Phase 1
Where in United States
- Ohio State Havener Eye Institute;Ophthalmology ResearchColumbus, United StatesTaking people
- Global Research ManagementGlendale, United StatesTaking people
- University Retina and Macula Associates, PCOak Forest, United StatesTaking people
- Medical Center Ophthalmology AssociatesSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07588100
- Record updated
- 9 November 2026
- Original description
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).Read full original descriptionShow less
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
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Inclusion: 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: 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; Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below; Vitreoretinal surgery/pars plana vitrectomy; Aphakia or previous violation of the posterior capsule in the study eye; Ocular Exclusion Criteria for the Non-study Eye; 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; Any history of glaucoma surgery or planned glaucoma surgery during the study; 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; General Exclusion Criteria:; Center-involved Diabetic Macular Edema (DME); Uncontrolled glaucoma; Anterior segment neovascularization; BCVA < 38 letters.