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)
Signed informed consent before any protocol-specified assessment is performed
Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
≥18 years of age at time of signing informed consent
Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
Macular conditions other than DME
History or presence of moderate Proliferative Diabetic Retinopathy or worse
History of retinal detachment in the study eye
History or presence of active inflammation or infection in either eye
Parallel
4D-150 IVT (3x10^10 vg)
Biological/VaccineIf 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
EYELEA ® (aflibercept) Injection 2 mg (0.05mL)
Biological/VaccineEYLEA ® (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
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
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
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