A Phase 3 interventional study of 4D-150 IVT (3x10^10 vg) and EYELEA ® (aflibercept) Injection 2 mg (0.05mL) in Diabetic Macular Edema (DME), sponsored by 4D Molecular Therapeutics. Recruiting at 82 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by 4D Molecular Therapeutics · Phase 3, Interventional, and Treatment
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)
747 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.
This study's planned enrollment of 514 is above the median of 69 across 554 interventional studies indexed under Eye Diseases.
Browse Eye Diseases studies →4D Molecular Therapeutics is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
5.2 Inclusion Criteria
Individuals eligible to participate in the trial must meet the following inclusion criteria:
General Inclusion Criteria
Exclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible to participate:
Ocular Condition
Uncontrolled glaucoma or intraocular hypertension
Ocular Treatments/Interventions:
Biological: 4D-150 IVT (3x10^10 vg)
Biological: EYELEA ® (aflibercept) Injection 2 mg (0.05mL)
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
EYLEA ® (aflibercept) will be administered at applicable visits
Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
The minimum and maximum values are: 0 to 100 The higher the value the better the result
Time frame: 52 weeks
Mean annualized number of aflibercept injections after Week 4 through Week 52
Minimum 0 maximum 12 One injection per visit, one visit every four weeks
Time frame: Week 4 through Week 52
Proportion of participants with a ≥ 2-step improvement from baseline in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52
ETDRS-DRSS is a visual acuity test Results are analyzing using a generalized estimating equations model
Time frame: 52 weeks
Plan to share: Yes — Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in DME in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA)
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2029, 28 months after the start.
Of 58 industry-sponsored phase 3 interventional studies under Eye Diseases, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 28 months is above that.
Counting every sponsor, half of 70 studies reached it within 12 months; a quarter within 8 and three quarters within 24.
Eye Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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4D Molecular Therapeutics