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NCT07817121Not yet recruitingPhase 1

A First-in-human Trial of SZN-8141 in Diabetic Macular Edema

A First-in-human, Prospective Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of SZN-8141 in Diabetic Macular Edema

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
9 (estimated)
First submitted
8 Sept 2026
Start date
30 Oct 2026
Primary completion date
31 Aug 2027
Lead sponsor
Surrozen Operating, Inc.
NCT number
NCT07817121

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 9
  • From 30 Oct 2026 to the primary completion date, 31 Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Stroke (cerebral vascular accident) or myocardial infarction \<6 months before Day 1
  • Any treatment with panretinal photocoagulation or macular laser in the study eye
  • Any planned surgery in the study eye during the course of the study

Other illness

  • Active cancer within the past 12 months
  • Any history of idiopathic or immune-mediated uveitis in either eye
  • 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
  • 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.

Other

  • Be pregnant or breastfeeding
  • High risk proliferative diabetic retinopathy (PDR) in the study eye
  • Uncontrolled glaucoma

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.