A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Who can participate
Inclusion Criteria:
* ≥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:
1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
2. 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
Exclusion Criteria:
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:
* 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
* Uncontrolled blood pressure
* 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
Locations
14
Argentina (1)
Grupo Láser Visión
Rosario , Santa Fe Province
Australia (1)
Adelaide Eye and Retina Centre
Adelaide
Bulgaria (1)
Zora Eye Hospital
Sofia
Germany (1)
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf
Hungary (1)
Bajcsy-Zsilinszky Kórház
Budapest
Italy (1)
AOU delle Marche
Ancona
Japan (1)
Kozawa Eye Hospital and Diabetes Center
Mito , Ibaraki
Latvia (1)
P.Stradins University Hospital
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences