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

Korábbi kezelés

• Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye
  • Systemic Conditions and Considerations:
• Major illness or major surgical procedure in the 28 days prior to the Screening Visit

Más betegség

• Ocular Conditions:
• 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
  • Ocular Treatments/Interventions:
• Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
• History of autoimmune condition that may predispose to the development of uveitis

Egyéb

• Uncontrolled blood pressure

• ≥50 years of age at time of consent
• MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
  • 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
• Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
• BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
• CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center