A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

Korábbi kezelés

• Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening
• Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins

Más betegség

• History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study
• Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study
• History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye
• Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization

Laborértékek

• History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation

Egyéb

• Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:
• Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
• Scar, fibrosis, or atrophy involving the central subfield in the study eye
• Scar or fibrosis involving > 50% of the total lesion in the study eye
• Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
• Other protocol-specified exclusion criteria

• Men or women ≥ 50 years old, capable of giving signed informed consent
• Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
• Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE
• The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
• Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea