NCT07588100 · Hoffmann-La Roche
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
(CENOTE)
What this study is about
This study will assess the safety, tolerability, and how the drug moves through the body (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
View original scientific description
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Interventions
DRUG
RO7663498
Participants will receive RO7663498 as per the schedule defined in the protocol.
Primary outcome measures
Percentage of Participants With Ocular Adverse Events (AEs)
Time frame: Up to Week 20
Percentage of Participants With Systemic (non-ocular) AEs
Time frame: Up to Week 20
Number of Abnormalities Recorded in Standard Ophthalmological Assessments
Time frame: Up to Week 20
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Glendale, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations