Diabetic Macular EdemaPhase 1NCT07425522
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
A Phase 1 study testing RO7823653 and Faricimab in people with Diabetic Macular Edema, run by Genentech, Inc. at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- RO7823653 and Faricimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Apr 2026to 17 Nov 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
- Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association
- Glycated hemoglobin (HbA1c) <= 12%
- For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) >= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters
Who cannot join
- Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- Uncontrolled blood pressure
- For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.
- For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant
- History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
- Active intraocular inflammation in either eye
- Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Retina Research Institute of Texas
Abilene, Texas, 79606-1224
- Recruiting
Austin Clinical Research, LLC
Austin, Texas, 78750-2298
- Recruiting
Wilmer Eye Institute
Baltimore, Maryland, 21287-0005
- Recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211-1838
- Recruiting
Erie Retina Research, LLC - 300 State St
Erie, Pennsylvania, 16507-1429
- Recruiting
Charles Retina Institute
Germantown, Tennessee, 38138-2405
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502-4271
- Recruiting
Associated Retina Consultants - Peoria - DocTrials - PPDS
Peoria, Arizona, 85381-3690
- Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107-5109
- Recruiting
Retina Consultants of Texas Westover Hills Retina Center
San Antonio, Texas, 78251
- Recruiting
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711-1141
- Recruiting
Bay Area Retina Specialists Medical Group - Vestrum - PPDS
Walnut Creek, California, 94598-5915
About this study
Official title: A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
- Conditions
- Diabetic Macular Edema
- Being tested
- RO7823653, Faricimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7823653Drug
Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.
FaricimabDrug
Participants will receive faricimab as an IVT injection per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Multiple Ascending Dose (MAD) Monotherapy | Experimental | Participants will receive multiple doses of RO7823653, administered as an IVT injection. Receives: Drug: RO7823653 |
| Part 2: Optional Multiple-Dose Expansion | Experimental | Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage. Receives: Drug: RO7823653 |
| Part 3: MAD (RO7823653 + Faricimab) | Experimental | Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection. Receives: Drug: RO7823653; Drug: Faricimab |
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) and Systemic AEs
Measured: Up to approximately 20 Weeks
Secondary outcomes (6)
Serum Concentrations of RO7823653
Measured: Up to approximately 20 Weeks
Aqueous Humor Concentrations of RO7823653
Measured: Up to approximately 20 Weeks
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653
Measured: Up to approximately 20 Weeks
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score
Measured: Up to approximately 20 Weeks
Change From Baseline in Retinal Thickness
Measured: Up to approximately 20 Weeks
Recommended Dose of RO7823653
Measured: Up to approximately 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start21 Apr 2026
- Primary completion17 Nov 2028 (estimated)
- Study completion17 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425522
- Sponsor's protocol ID
- GR46431
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2026
- Last updated
- 9 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07425522
- Acronym / sponsor ID
- GR46431
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 17 Nov 2028 (estimated)
- Study completion
- 17 Nov 2028 (estimated)
- First posted
- 23 Feb 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.
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Multiple Ascending Dose (MAD) Monotherapy | Experimental | Drug: RO7823653Participants will receive multiple doses of RO7823653, administered as an IVT injection. |
| Part 2: Optional Multiple-Dose Expansion | Experimental | Drug: RO7823653Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage. |
| Part 3: MAD (RO7823653 + Faricimab) | Experimental | Drug: RO7823653, Drug: FaricimabParticipants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association
- Glycated hemoglobin (HbA1c) <= 12%
- For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) >= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters
Key exclusion criteria (8 listed)
- Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- Uncontrolled blood pressure
- For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.
- For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant
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 |
|---|---|---|
| RO7823653Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol. | Drug | Part 1: Multiple Ascending Dose (MAD) Monotherapy, Part 2: Optional Multiple-Dose Expansion, Part 3: MAD (RO7823653 + Faricimab) |
| FaricimabParticipants will receive faricimab as an IVT injection per the schedule described in the protocol. | Drug | Part 3: MAD (RO7823653 + Faricimab) |
Primary outcome
Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs
Time frame: Up to approximately 20 Weeks
6 secondary outcomes
Serum Concentrations of RO7823653
Time frame: Up to approximately 20 Weeks
Aqueous Humor Concentrations of RO7823653
Time frame: Up to approximately 20 Weeks
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7823653
Time frame: Up to approximately 20 Weeks
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score
Time frame: Up to approximately 20 Weeks
Change From Baseline in Retinal Thickness
Time frame: Up to approximately 20 Weeks
Recommended Dose of RO7823653
Time frame: Up to approximately 20 Weeks
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 9 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 GR46431 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Genentech, Inc.
12 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 RO7823653 and Faricimab in people with Diabetic Macular Edema, run by Genentech, Inc. at 12 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 3 inclusion and 8 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 9 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 12 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 GR46431 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), 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) and Systemic AEs (time frame: Up to approximately 20 Weeks). 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 9 Oct 2026.