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Neovascular (Wet) Age-Related Macular DegenerationPhase 2NCT07501052

Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, or Diabetic Retinopathy

A Phase 2 study testing SCD411 0.05mL (2mg) in people with Neovascular (Wet) Age-Related Macular Degeneration and Retinal Vein Occlusion, run by Sam Chun Dang Pharm. Co. Ltd. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SCD411 0.05mL (2mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesUnited States
Study dates
13 May 2026to 1 Jun 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University Retina & Macula Associates, P.C

    Lemont, Illinois, 60439

  • Retina Vitreous Surgeons of Central New York, PC

    Liverpool, New York, 13088

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: An Evaluation of the Clinical Usability of the SCD411 Prefilled Syringe as a Proposed Biosimilar to US-licensed Eylea®

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)

Being tested
SCD411 0.05mL (2mg)
Keywords
Usability Study
Medical subject headings
Macular Degeneration, Retinal Vein Occlusion, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCD411 0.05mL (2mg)Drug

    Also called aflibercept

    Single intravitreal therapy (IVT) injection using a prefilled syringe (PFS)

Study groups in NCT07501052
Study groupRoleWhat they receive
SCD411ExperimentalNot described
Receives: Drug: SCD411 0.05mL (2mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline [Day 1]

  2. 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

    Measured: Baseline [Day 1]

  3. 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

    Measured: Baseline [Day 1]

Secondary outcomes (3)

  1. Number of ocular adverse events (AEs) in the study eye

    Measured: Baseline through follow up visit - approximately 7 (+2) days post injection

  2. Number of serious adverse events (SAEs) in the study eye

    Measured: Baseline through follow up visit - approximately 7 (+2) days post injection

  3. Number of non-ocular SAEs

    Measured: Baseline through follow up visit - approximately 7 (+2) days post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start13 May 2026
  3. Primary completion27 May 2026
  4. Study completion1 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07501052
Sponsor's protocol ID
SCD411-CP102
Status last verified
Jun 2026
First submitted
24 Mar 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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