An Evaluation of the Clinical Usability of the SCD411 Prefilled Syringe as a Proposed Biosimilar to US-licensed Eylea®
Sam Chun Dang Pharm. Co. Ltd.
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugSCD411 0.05mL (2mg)
Single intravitreal therapy (IVT) injection using a prefilled syringe (PFS)
Locations (4)
- East Florida Eye InstituteStuart, Florida
- Center for Retina and Macular DiseaseWinter Haven, Florida
- University Retina & Macula Associates, P.CLemont, Illinois
- Retina Vitreous Surgeons of Central New York, PCLiverpool, New York