Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degenerati… (NCT07501052) | Clinical Trial Compass
CompletedPhase 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 2026-05-13
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a prefilled syringe device called SCD411 rather than a new drug — does that mean the medication itself is already approved, and what would be different about how it's delivered compared to what I'm currently receiving or would normally receive?
2Since this Phase 2 trial has already completed and was focused on whether patients and caregivers can correctly and safely use the prefilled syringe on their own, does my doctor know if the results showed any safety concerns or common errors during use that I should be aware of?
3The trial covered four different eye conditions — wet AMD, retinal vein occlusion, diabetic macular edema, and diabetic retinopathy — so given my specific diagnosis, would a device like this prefilled syringe actually change anything meaningful about my treatment plan or outcomes?
4Because this study measured whether people could successfully complete tasks like opening the carton, using the device, and disposing of it safely, is there any concern that self-administration or at-home use might become part of my treatment in the future, and how would that affect the monitoring I'd need?
5Since this trial is completed, is there a next phase planned that I might be eligible to discuss with my care team, or is the standard in-clinic injection still the recommended path for my condition right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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