Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

Korábbi kezelés

• Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
• Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
• Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.

Más betegség

• History of idiopathic or autoimmune uveitis in the study eye.
• History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
• Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.

Egyéb

• Causes of CNV other than nAMD in the study eye.
• Scar, fibrosis, or atrophy involving the central subfield in the study eye.
• Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
• Other protocol-specified exclusion criteria

• Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
• Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
• BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
• Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
• Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
• Other protocol-specified inclusion criteria.
  • Additional inclusion criteria for Year 3:
• At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
• Participant is enrolled at a site that participates in the extension period.