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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Single intravitreal therapy (IVT) injection using a prefilled syringe (PFS)
East Florida Eye Institute
Stuart, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
University Retina & Macula Associates, P.C
Lemont, Illinois, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Percentage of successful task completions for product use tasks (from opening the carton to disposal of the used PFS and needle)
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
Time frame: Baseline [Day 1]
Percentage of successful completions of safety-related critical tasks
Critical tasks are tasks that, if not performed correctly (or at all), would or could cause serious harm to the patient or user
Time frame: Baseline [Day 1]
Percentage of successful completions of essential tasks
Essential tasks are tasks that are not critical but are required to complete the use process for effective use of SCD411
Time frame: Baseline [Day 1]
Number of ocular adverse events (AEs) in the study eye
Time frame: Baseline through follow up visit - approximately 7 (+2) days post injection
Number of serious adverse events (SAEs) in the study eye
Time frame: Baseline through follow up visit - approximately 7 (+2) days post injection
Number of non-ocular SAEs
Time frame: Baseline through follow up visit - approximately 7 (+2) days post injection
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