RecruitingDiabetic Retinopathy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Sponsor: Hoffmann-La Roche
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07588100 · last updated 2026-09-14