Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degenerati⦠(NCT07501052) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, or Diabetic Retinopathy
United States33 participantsStarted 2026-05-08
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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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 ā„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 ā¦
What they're measuring
1
Percentage of successful task completions for product use tasks (from opening the carton to disposal of the used PFS and needle)
Timeframe: Baseline [Day 1]
2
Percentage of successful completions of safety-related critical tasks
Timeframe: Baseline [Day 1]
3
Percentage of successful completions of essential tasks