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New syringe for eye disease injections passes usability test

NCT ID NCT07501052

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether doctors could safely and correctly use a new prefilled syringe (SCD411) for eye injections. It included 33 adults with wet age-related macular degeneration, retinal vein occlusion, diabetic macular edema, or diabetic retinopathy. The main goal was to see if doctors could complete tasks like opening, injecting, and disposing of the syringe without errors. This was not a treatment study—it focused on how easy and safe the device is to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

May 2026

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Retina Vitreous Surgeons of Central New York, PC

    Liverpool, New York, 13088, United States

  • University Retina & Macula Associates, P.C

    Lemont, Illinois, 60439, United States

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