NCT07588100RecruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 May 2026
- Start date
- 18 Jun 2026
- Primary completion date
- 20 Jan 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Diabetic eye disease
- NCT number
- NCT07588100
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 18 Jun 2026 to the primary completion date, 20 Jan 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- General Exclusion Criteria:
- Center-involved Diabetic Macular Edema (DME)
- Uncontrolled glaucoma
- Anterior segment neovascularization.
- BCVA \< 38 letters
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State Havener Eye Institute;Ophthalmology Research Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Global Research Management Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| University Retina and Macula Associates, PC Coordinator of this site? Confirm its status | Oak Forest | United States | Recruiting |
| Medical Center Ophthalmology Associates Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.