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

March 24, 2026 updated by: Sam Chun Dang Pharm. Co. Ltd.

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
        • Contact:
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
        • Contact:
        • Contact:
          • Tammy McCarty
          • Phone Number: 2022 863-297-5400
          • Email: tamc@crmd.net
    • Illinois
      • Lemont, Illinois, United States, 60439
        • University Retina & Macula Associates, P.C
        • Contact:
    • New York
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of Central New York, PC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCD411
Drug: SCD411 0.05mL (2mg)
Single intravitreal therapy (IVT) injection using a prefilled syringe (PFS)
Other Names:
  • aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of successful task completions for product use tasks (from opening the carton to disposal of the used PFS and needle)
Time Frame: Baseline [Day 1]
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
Baseline [Day 1]
Percentage of successful completions of safety-related critical tasks
Time Frame: Baseline [Day 1]
Critical tasks are tasks that, if not performed correctly (or at all), would or could cause serious harm to the patient or user
Baseline [Day 1]
Percentage of successful completions of essential tasks
Time Frame: Baseline [Day 1]
Essential tasks are tasks that are not critical but are required to complete the use process for effective use of SCD411
Baseline [Day 1]

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of ocular adverse events (AEs) in the study eye
Time Frame: Baseline through follow up visit - approximately 7 (+2) days post injection
Baseline through follow up visit - approximately 7 (+2) days post injection
Number of serious adverse events (SAEs) in the study eye
Time Frame: Baseline through follow up visit - approximately 7 (+2) days post injection
Baseline through follow up visit - approximately 7 (+2) days post injection
Number of non-ocular SAEs
Time Frame: Baseline through follow up visit - approximately 7 (+2) days post injection
Baseline through follow up visit - approximately 7 (+2) days post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sam Chun Dang Pharm. Co. Ltd.

Investigators

  • Study Director: Byung Jhip Ha, Sam Chun Dang Pharm. Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 8, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCD411-CP102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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