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

NCT07501052 | Completed Phase 2 FDA Drug

• 1 other identifier: SCD411-CP102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

Brief 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)

Conditions

Retinal Vein Occlusion; Diabetic Macular Edema; Neovascular (Wet) Age-Related Macular Degeneration; Diabetic Retinopathy

Keywords

Usability Study

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline [Day 1]

• 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

  Baseline [Day 1]

• 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

  Baseline [Day 1]

Secondary Outcomes (3)

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

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

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

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

• Number of non-ocular SAEs

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

Study Arms (1)

SCD411

EXPERIMENTAL

Drug: SCD411 0.05mL (2mg)

Interventions

SCD411 0.05mL (2mg) DRUG

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

Also known as: aflibercept

SCD411

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sam Chun Dang Pharm. Co. Ltd.: lead

Study Sites (4)

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

University Retina & Macula Associates, P.C

Lemont, Illinois, 60439, United States

Location

Retina Vitreous Surgeons of Central New York, PC

Liverpool, New York, 13088, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion; Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Byung Jhip Ha

  Sam Chun Dang Pharm. Co. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: May 13, 2026
• Primary Completion: May 27, 2026
• Study Completion: June 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)