This trial is no longer recruiting.My employer runs this trial

SCD411 for Age-Related Macular Degeneration

No longer recruiting at 3 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called SCD411, a new potential drug, to evaluate its effectiveness and ease of use for individuals with certain retinal conditions. These conditions include Wet Age-Related Macular Degeneration, which can cause vision loss, Diabetic Retinopathy, an eye disease from diabetes, Retinal Vein Occlusion, a blockage in the eye's veins, and Diabetic Macular Edema, swelling in the retina due to diabetes. The goal is to determine if SCD411 can be a safe and effective option for managing these conditions. Individuals with one of these conditions who can attend all study visits might be suitable candidates for the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain eye treatments like anti-VEGF injections or intraocular corticosteroids recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SCD411 is likely to be safe for humans?

Previous studies have shown that SCD411 has a safety profile similar to aflibercept, a well-known treatment. The side effects and risks are comparable to those expected from current treatments for age-related macular degeneration. These studies reported no major safety concerns. Most patients tolerated SCD411 well, with side effects resembling those of other treatments in its category. This suggests that SCD411 is likely safe for human use, based on earlier research data.12345

Why do researchers think this study treatment might be promising for AMD?

Unlike the standard treatments for age-related macular degeneration, which often involve injections like anti-VEGF drugs (such as Lucentis or Eylea) to slow vision loss, SCD411 offers a new approach. Researchers are excited about SCD411 because it targets a different pathway related to retinal health, potentially addressing underlying disease mechanisms rather than just symptoms. This novel mechanism could mean fewer injections and longer-lasting effects, offering hope for improved vision retention and quality of life for patients.

What evidence suggests that SCD411 might be an effective treatment for Age-Related Macular Degeneration?

Research has shown that SCD411, the investigational treatment in this trial, works as effectively as aflibercept, a common treatment for wet age-related macular degeneration (wet AMD). Studies have found it similarly effective in helping patients maintain or improve their vision. Additionally, SCD411 shares a similar safety profile with aflibercept, indicating it does not pose additional risks compared to the current treatment. These findings suggest that SCD411 could be a reliable option for managing wet AMD.23467

Who Is on the Research Team?

BJ

Byung Jhip Ha

Principal Investigator

Sam Chun Dang Pharm. Co. Ltd.

Are You a Good Fit for This Trial?

This trial is for adults (18+) diagnosed with wet age-related macular degeneration, retinal vein occlusion, diabetic macular edema, or diabetic retinopathy in at least one eye. Participants must be able to give consent and attend all study visits.

Inclusion Criteria

I am 18 years old or older.
* Be capable of understanding the written informed consent and signed informed consent (patient or legally authorized representative)
* Be an ophthalmologist with a retinal specialty or with IVT training
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SCD411 prefilled syringe for treatment of their condition

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SCD411

Trial Overview

The study tests a prefilled syringe containing SCD411 (2mg) given as an injection into the eye to treat certain vision-threatening conditions. All participants receive this treatment; there is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SCD411Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sam Chun Dang Pharm. Co. Ltd.

Lead Sponsor

Trials
1
Recruited
580+

Citations

Comparison of the efficacy and safety of SCD411 and ... - PMC

SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38926553/

Comparison of the efficacy and safety of SCD411 ...

SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety ...

NCT04480463 | A Study to Comparing SCD411 and Eylea ...

The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the ...

(PDF) Comparison of the efficacy and safety of SCD411 ...

SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety ...

NCT07501052 | Study of the SCD411 Prefilled Syringe for ...

This is a single-arm, multicenter study to evaluate clinical usability of a pre-filled syringe containing SCD411 in adult patients with neovascular Wet ...

Comparison of the efficacy and safety of SCD411 ...

SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety ...

Comparison of the efficacy and safety of SCD411 ...

In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration ...