Diabetic Macular Edema, Diabetic Retinopathy, Neovascular (Wet) Age-Related Macular Degeneration, Retinal Vein Occlusion
Conditions
Keywords
Usability Study
Brief summary
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)
Interventions
DRUGSCD411 0.05mL (2mg)
Single intravitreal therapy (IVT) injection using a prefilled syringe (PFS)
Sponsors
Sam Chun Dang Pharm. Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of successful task completions for product use tasks (from opening the carton to disposal of the used PFS and needle) | Baseline [Day 1] | Successful completion is defined as achieving the correct results without a usage error. A usage error is defined as an action or lack of action by the user of the PFS that leads to a result that is not intended by the manufacturer |
| Percentage of successful completions of safety-related critical tasks | Baseline [Day 1] | Critical tasks are tasks that, if not performed correctly (or at all), would or could cause serious harm to the patient or user |
| Percentage of successful completions of essential tasks | Baseline [Day 1] | Essential tasks are tasks that are not critical but are required to complete the use process for effective use of SCD411 |
Secondary
| Measure | Time frame |
|---|---|
| Number of ocular adverse events (AEs) in the study eye | Baseline through follow up visit - approximately 7 (+2) days post injection |
| Number of serious adverse events (SAEs) in the study eye | Baseline through follow up visit - approximately 7 (+2) days post injection |
| Number of non-ocular SAEs | Baseline through follow up visit - approximately 7 (+2) days post injection |
Countries
United States
Contacts
STUDY_DIRECTORByung Jhip Ha
Sam Chun Dang Pharm. Co. Ltd.
Outcome results
None listed