Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
Sponsor4D Molecular Therapeutics

About this trial

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Eligibility criteria

Qualifiers

≥50 years of age at time of consent

Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR

Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator

Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center

Disqualifiers

MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)

History of retinal detachment in the study eye

History of or presence of active inflammation in either eye

Glaucoma or intraocular hypertension requiring more than 2 topical medications for control

Trial design

Treatments tested in this trial

  • 4D-150 IVT (3E10 vg/eye)
  • EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Treatment groups

480 Participants
are divided into 2 treatment groups

Sponsors and collaborators