Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, or Diabetic Retinopathy

An Evaluation of the Clinical Usability of the SCD411 Prefilled Syringe as a Proposed Biosimilar to US-licensed Eylea®

This is a single-arm, multicenter study to evaluate clinical usability of a pre-filled syringe containing SCD411 in adult patients with neovascular Wet Age-Related Macular Degeneration (AMD), Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), or Diabetic Retinopathy (DR)

Inclusion Criteria:

Providers must meet all of the following criteria to be eligible for the study:

• Be an ophthalmologist with a retinal specialty or with IVT training
• Be board-certified by the American Board of Ophthalmology
• Be licensed to practice medicine in the state where patients are seen
• Be able to conduct physical examinations, including but not limited to ophthalmic examinations, on patients prior to and after injection
• Have access to appropriate tools and equipment for pre- and post-injection examinations and monitoring

Patients must meet all of the following criteria to be eligible for the study:

• Be ≥18 years of age
• Have a confirmed diagnosis of neovascular AMD, DME, RVO, or DR (uni- or bilateral)
• Have a study eye deemed to be indicated for treatment with SCD411 IVT therapy, as indicated on the US-Eylea label
• Be capable of understanding the written informed consent and signed informed consent (patient or legally authorized representative)
• Be willing and able to attend all scheduled study visits and comply with protocol requirements

Exclusion Criteria:

Patients meeting any of the following criteria will not be eligible for the study:

• Have active intraocular or periocular infection or active intraocular inflammation (grade: trace or above) in the study eye at Baseline, which is of clinical significance according to the investigator's (HCP's) judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune-associated uveitis, or endophthalmitis
• Have uncontrolled IOP >25 millimeters of mercury (mmHg) in the study eye at Screening or Day 1 (uncontrolled defined as IOP >25 mmHg despite IOP-lowering therapy)
• Be deemed legally blind in one or both eyes (Best-corrected visual acuity [BCVA] of 20/200 or worse)
• Have a history of or any current indication of excessive bleeding or recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
• Have current systemic infectious disease
• Have a history of any medical, ocular, or non-ocular conditions that, in the opinion of the HCP, may interfere with the injection procedure or pose a safety concern
• Have a history of stroke or transient ischemic attacks or myocardial infarction
• Have uncontrolled hypertension (defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg at Screening, even if taking antihypertensive medication)
• Have received treatment with anti-VEGF (vascular endothelial growth factor) IVT injection in the study eye within 28 days prior to Screening
• Have any use of intraocular corticosteroids in the study eye within 3 months prior to Screening
• Have received any systemic anti-VEGF within the 6 months prior to Screening
• Have received any invasive intraocular surgery, prior long-acting therapeutic agent, or implantation of an ocular drug-release device (approved or investigational) in the study eye within the past 3 months prior to Screening
• Be a woman who is pregnant or breastfeeding or planning to become pregnant while enrolled in the study and for 3 months after SCD411 administration
• Be a sexually active patient or their partner, be of childbearing potential (i.e., neither surgically sterile nor post-menopausal), and refuse to use adequate contraception (e.g., true abstinence, sterilization, injectable hormonal contraception, birth control pills, contraceptive implants, or other highly effective methods) while in the study and for 3 months after SCD411 administration. Male patients must agree not to donate sperm during the study and for 3 months following a dose of SCD411
• Have an allergy or hypersensitivity to SCD411, to any of the excipients of SCD411 or aflibercept, or to other study-related procedures/medications (e.g., anesthesia, antiseptic)
• Have previously been enrolled in this study
• Have participated in any interventional clinical study within 3 months prior to screening