Diabetic Macular Edema (DME)Phase 1DUETNCT07817121
A First-in-human Trial of SZN-8141 in Diabetic Macular Edema
A Phase 1 study testing SZN-8141 for Injection in people with Diabetic Macular Edema (DME), run by Surrozen Operating, Inc..
Trial summary
DUET (Cl-8141-1001) is a first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics (how the body processes the study drug), and preliminary biological activity of SZN-8141 in people with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- SZN-8141 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 31 Aug 2027
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- Age ≥18 years and ≤90 years old
- Documented diagnosis of diabetes mellitus (type 1 or 2), as defined by the American Diabetes Association or per World Health Organization (WHO) criteria
- Hemoglobin A1C (HbA1c) of ≤12% for ≤60 days before Day 1
- Macular thickening secondary to DME involving the center of the fovea with CST ≥325 μm on OCT as determined by the central reading center at the screening visit
- Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
- BCVA of 73-25 ETDRS letters inclusive (20/40-20/200 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 m on Day 1
- Treatment naïve and previously treated participants with protocol specified drug washout
Who cannot join
- Be pregnant or breastfeeding
- Active cancer within the past 12 months
- Stroke (cerebral vascular accident) or myocardial infarction <6 months before Day 1
- High risk proliferative diabetic retinopathy (PDR) in the study eye
- Any treatment with panretinal photocoagulation or macular laser in the study eye
- Any history of idiopathic or immune-mediated uveitis in either eye
Show all 12Show fewer
- Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 1
- History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or intraocular glaucoma surgery in the study eye
- Any planned surgery in the study eye during the course of the study
- Uncontrolled glaucoma
- Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the trial
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A First-in-human, Prospective Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of SZN-8141 in Diabetic Macular Edema
DUET (Cl-8141-1001) is a first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics (how the body processes the study drug), and preliminary biological activity of SZN-8141 in people with diabetic macular edema (DME). In this study, small groups of participants with DME (approximately three participants per dose group) will receive a single injection of SZN-8141 into the eye and will be followed for approximately 3 months.
During the trial, participants will undergo regular assessments to monitor their overall health and eye condition. These assessments include eye examinations, vision testing, retinal imaging, laboratory testing, and blood sample collection to measure levels of SZN-8141 in the bloodstream and to assess whether the body develops anti-drug antibodies.
The trial uses an ascending-dose design, in which successive groups of participants receive increasing dose levels of SZN-8141. Safety and tolerability data from each dose group will be reviewed before the next higher dose level is evaluated.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- SZN-8141 for Injection
- Keywords
- Diabetic macular edema, SZN-8141, Wnt, VEGF, FZD4, LRP5, biologic, multispecific, Intravitreal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZN-8141 for InjectionBiological
Also called SZN-8141
SZN-8141 for Injection is a humanized antibody formulated for IVT administration
| Study group | Role | What they receive |
|---|---|---|
| SZN-8141 Single Ascending Dose Level 1 | Experimental | Participants will receive a single dose of SZN-8141 for Injection Receives: Biological: SZN-8141 for Injection |
| SZN-8141 Single Ascending Dose Level 2 | Experimental | Participants will receive a single dose of SZN-8141 for Injection Receives: Biological: SZN-8141 for Injection |
| SZN-8141 Single Ascending Dose Level 3 | Experimental | Participants will receive a single dose of SZN-8141 for Injection Receives: Biological: SZN-8141 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events
Measured: Up to 12 weeks
Secondary outcomes (4)
Change in Best Corrected Visual Acuity from Baseline
BCVA will be measured via ETDRS chart at a starting distance of 4 meters
Measured: Up to 12 weeks
Changes in Central Subfield Thickness from Baseline
CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by the Central Reading Center from evaluation of optical coherence tomography images.
Measured: Up to 12 weeks
Systemic Drug concentrations of SZN-8141
Measured: Up to 12 weeks
Incidence of anti-drug antibodies against SZN-8141
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surrozen Operating, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817121
- Sponsor's protocol ID
- CL-8141-1001
- Acronym
- DUET
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Prospective Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of SZN-8141 in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07817121
- Acronym / sponsor ID
- DUET / CL-8141-1001
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- Diabetic macular edema, SZN-8141, Wnt, VEGF, FZD4, LRP5, biologic, multispecific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Surrozen Operating, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Sep 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.
DUET (Cl-8141-1001) is a first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics (how the body processes the study drug), and preliminary biological activity of SZN-8141 in people with diabetic macular edema (DME). In this study, small groups of participants with DME (approximately three participants per dose group) will receive a single injection of SZN-8141 into the eye and will be followed for approximately 3 months.
During the trial, participants will undergo regular assessments to monitor their overall health and eye condition. These assessments include eye examinations, vision testing, retinal imaging, laboratory testing, and blood sample collection to measure levels of SZN-8141 in the bloodstream and to assess whether the body develops anti-drug antibodies.
The trial uses an ascending-dose design, in which successive groups of participants receive increasing dose levels of SZN-8141. Safety and tolerability data from each dose group will be reviewed before the next higher dose level is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SZN-8141 Single Ascending Dose Level 1 | Experimental | Biological: SZN-8141 for InjectionParticipants will receive a single dose of SZN-8141 for Injection |
| SZN-8141 Single Ascending Dose Level 2 | Experimental | Biological: SZN-8141 for InjectionParticipants will receive a single dose of SZN-8141 for Injection |
| SZN-8141 Single Ascending Dose Level 3 | Experimental | Biological: SZN-8141 for InjectionParticipants will receive a single dose of SZN-8141 for Injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- Age ≥18 years and ≤90 years old
- Documented diagnosis of diabetes mellitus (type 1 or 2), as defined by the American Diabetes Association or per World Health Organization (WHO) criteria
- Hemoglobin A1C (HbA1c) of ≤12% for ≤60 days before Day 1
- Macular thickening secondary to DME involving the center of the fovea with CST ≥325 μm on OCT as determined by the central reading center at the screening visit
Key exclusion criteria (12 listed)
- Be pregnant or breastfeeding
- Active cancer within the past 12 months
- Stroke (cerebral vascular accident) or myocardial infarction <6 months before Day 1
- High risk proliferative diabetic retinopathy (PDR) in the study eye
- Any treatment with panretinal photocoagulation or macular laser in the study eye
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 |
|---|---|---|
| SZN-8141 for InjectionAlso: SZN-8141SZN-8141 for Injection is a humanized antibody formulated for IVT administration | Biological | SZN-8141 Single Ascending Dose Level 1, SZN-8141 Single Ascending Dose Level 2, SZN-8141 Single Ascending Dose Level 3 |
Primary outcome
Incidence and severity of treatment-emergent adverse events
Time frame: Up to 12 weeks
4 secondary outcomes
Change in Best Corrected Visual Acuity from Baseline
Time frame: Up to 12 weeks
Changes in Central Subfield Thickness from Baseline
Time frame: Up to 12 weeks
Systemic Drug concentrations of SZN-8141
Time frame: Up to 12 weeks
Incidence of anti-drug antibodies against SZN-8141
Time frame: Up to 12 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 14 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SZN-8141 for Injection in people with Diabetic Macular Edema (DME), run by Surrozen Operating, Inc..
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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Surrozen Operating Inc. (650-420-7056, duetclinicaltrial@surrozen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (time frame: Up to 12 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 14 Sep 2026.