Diabetic RetinopathyPhase 1CENOTENCT07588100
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
A Phase 1 study testing RO7663498 in people with Diabetic Retinopathy, run by Hoffmann-La Roche at 4 sites in United States.
Trial summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- RO7663498
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jun 2026to 20 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
United States4 sites, 4 recruiting
- Recruiting
Ohio State Havener Eye Institute;Ophthalmology Research
Columbus, Ohio, 43212
- Recruiting
Global Research Management
Glendale, California, 91204
- Recruiting
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452
- Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
About this study
Official title: 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).
- Conditions
- Diabetic Retinopathy
- Being tested
- RO7663498
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7663498Drug
Participants will receive RO7663498 as per the schedule defined in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive RO7663498. Receives: Drug: RO7663498 |
| Cohort 2 | Experimental | Participants will receive RO7663498. Receives: Drug: RO7663498 |
| Cohort 3 | Experimental | Participants will receive RO7663498. Receives: Drug: RO7663498 |
| Cohort 4 | Experimental | Participants will receive RO7663498. Receives: Drug: RO7663498 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Ocular Adverse Events (AEs)
Measured: Up to Week 20
Percentage of Participants With Systemic (non-ocular) AEs
Measured: Up to Week 20
Number of Abnormalities Recorded in Standard Ophthalmological Assessments
Measured: Up to Week 20
Secondary outcomes (2)
Aqueous Humor (AH) Concentrations of RO7663498
Measured: Up to Week 12
Serum Concentrations of RO7663498
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start18 Jun 2026
- Primary completion20 Jan 2028 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588100
- Sponsor's protocol ID
- BP46156
- Acronym
- CENOTE
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07588100
- Acronym / sponsor ID
- CENOTE / BP46156
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RO7663498Participants will receive RO7663498. |
| Cohort 2 | Experimental | Drug: RO7663498Participants will receive RO7663498. |
| Cohort 3 | Experimental | Drug: RO7663498Participants will receive RO7663498. |
| Cohort 4 | Experimental | Drug: RO7663498Participants will receive RO7663498. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7663498Participants will receive RO7663498 as per the schedule defined in the protocol. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
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
2 secondary outcomes
Aqueous Humor (AH) Concentrations of RO7663498
Time frame: Up to Week 12
Serum Concentrations of RO7663498
Time frame: Up to Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7663498 in people with Diabetic Retinopathy, run by Hoffmann-La Roche at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: BP46156 https://forpatients.roche.com/ No email attachments. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Ocular Adverse Events (AEs) (time frame: Up to Week 20). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.