A Phase 1 interventional study of SZN-8141 for Injection in Diabetic Macular Edema (DME), sponsored by Surrozen Operating, Inc.. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Surrozen Operating, Inc. · Phase 1, Interventional, and Treatment
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.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 9 is below the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →This is the only study on the registry with Surrozen Operating, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single dose of SZN-8141 for Injection
Biological: SZN-8141 for Injection
Participants will receive a single dose of SZN-8141 for Injection
Biological: SZN-8141 for Injection
Participants will receive a single dose of SZN-8141 for Injection
Biological: SZN-8141 for Injection
SZN-8141 for Injection is a humanized antibody formulated for IVT administration
Also known as: SZN-8141
Incidence and severity of treatment-emergent adverse events
Time frame: Up to 12 weeks
Change in Best Corrected Visual Acuity from Baseline
BCVA will be measured via ETDRS chart at a starting distance of 4 meters
Time frame: 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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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