A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intr… (NCT07588100) | Clinical Trial Compass
RecruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
United States30 participantsStarted 2026-06-18
Plain-language summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ass…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Ocular Adverse Events (AEs)
Timeframe: Up to Week 20
2
Percentage of Participants With Systemic (non-ocular) AEs
Timeframe: Up to Week 20
3
Number of Abnormalities Recorded in Standard Ophthalmological Assessments
Timeframe: Up to Week 20
Trial details
NCT IDNCT07588100
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-12-30
Contact for this trial
Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments.