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Trial record 1 of 1 for:    SCD411-Cp101
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A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT04480463
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sam Chun Dang Pharm. Co. Ltd.

Brief Summary:
Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. 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 movement of the drug through the body.

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Drug: SCD411 Drug: Aflibercept Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the unmasked investigator involved in performing the IVT injections will be unmasked to study treatment. These individuals are not allowed to discuss treatment and/or subject outcome with masked study staff, including the evaluating investigator.
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity Between SCD411 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCD411 Drug: SCD411
IVT (intravitreal) injection

Active Comparator: Aflibercept Drug: Aflibercept
IVT injection
Other Name: Eylea®




Primary Outcome Measures :
  1. Change from baseline in BCVA (best corrected visual acuity) [ Time Frame: Baseline to Week 8 ]
    Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts


Secondary Outcome Measures :
  1. Change from baseline in BCVA (best corrected visual acuity) [ Time Frame: Baseline to Week 52 ]
    Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

  2. Percentage of subjects with anti-SCD411 antibodies [ Time Frame: Baseline, Weeks 4, 8, 20, 36 and 52 ]
    Assessed by blood samples



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written informed consent.
  • Clinical diagnosis of wet (neovascular) age-related macular degeneration (AMD).
  • BCVA (best corrected visual acuity) letter score of 73 to 35 at screening and prior to randomization.
  • Women of child-bearing potential with negative serum pregnancy test at screening must agree to use protocol-defined methods of contraception throughout study until 3 months after last injection of aflibercept/SCD411.
  • Males with female partners of child-bearing potential must agree to use protocol-defined methods of contraception and refrain from donating sperm throughout study until 3 months after last injection of aflibercept/SCD411.

Exclusion Criteria:

  • Any prior eye (study eye and fellow eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
  • Any prior or current treatment with another investigational agent to great neovascular AMD in the study eye, except dietary supplements or vitamins.
  • Fellow eye shows signed of AMD that may need treatment during study period.
  • Any prior treatment with anti-VEGF agents in both eyes.
  • Blood, scars, atrophy, fibrosis, and neovascularization, based on assessment at screening.
  • Central retina thickness of <300 µm in the study eye.
  • Subretinal hemorrhage.
  • Scar or fibrosis.
  • Scar, fibrosis, or atrophy in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macular in the study eye.
  • Cataract in the study eye that, in the Investigator's opinion, interferes with visualization of retina or retinal imaging.
  • Inflammation outside the eyeball in either eye, or within the eyeball of the study eye.
  • History of any vitreous hemorrhage in the study eye.
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease.
  • History of, treatment or surgery for detached retina.
  • History of uncomplicated surgery within the eyeball or around the study eye, except lid surgery.
  • Absence of lens in study eye.
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) >180 mmHg or diastolic BP >100 mmHg under appropriate antihypertensive treatment.
  • Hypersensitivity to aflibercept or medications used in the study (fluorescein, mydriatic eye drops, etc.).
  • Pregnancy or lactation at Screening or at baseline for women of child-bearing potential.
  • History of blood clotting events.
  • History or evidence of cardiac conditions, or inability to perform any physical activity without discomfort; ventricular arrhythmia; and atrial fibrillation.
  • History of laser therapy in the macular region.
  • Any prior or current treatment with corticosteroids inside or immediately around the study eye.
  • Any prior or current treatment involving the macula with photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment in the study eye.
  • Any prior or current treatment with pan-retinal photocoagulation.
  • Any prior or current treatment with ethambutol; deferoxamine and topiramate; tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin; and amiodarone.
  • Any investigational product for the treatment of eye conditions and systemic conditions, 30 days or 5 half-lives (whichever is longer), prior to randomization, and throughout the study, except dietary supplements or vitamins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480463


Locations
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Sponsors and Collaborators
Sam Chun Dang Pharm. Co. Ltd.
Investigators
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Study Director: Byung Jhip Ha Sam Chun Dang Pharm. Co. Ltd.
Additional Information:
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Responsible Party: Sam Chun Dang Pharm. Co. Ltd.
ClinicalTrials.gov Identifier: NCT04480463    
Other Study ID Numbers: SCD411-CP101
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sam Chun Dang Pharm. Co. Ltd.:
Age-related macular degeneration
AMD
Neovascular
Exudative
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases