A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)
Condition: Wet Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: SCD411; Aflibercept
Intervention description: IVT (intravitreal) injection; IVT injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 576.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration; AMD; Neovascular; Exudative

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.
    

Eligibility 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. In addition, fellow eye should not be less than 35 letter score using
             the ETDRS chart or 2702 series number chart.

          -  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.

          -  Total lesion size >30.5 mm2, Blood, scars, atrophy, fibrosis, and neovascularization,
             based on assessment at screening.

          -  Central retina thickness of <300 µm in the study eye.

          -  Subretinal hemorrhage that is either 50% or more of the total lesion area.

          -  Scar or fibrosis making up >50% of the total lesion.

          -  Scar, fibrosis, or atrophy involving the center of the fovea 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 have Lens Opacity Classification System II (LOCS II)
             grade IV cataract in the study eye or 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) >160 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.

          -  Intraocular pressure ≥25 mmHg in spite of anti-glaucoma treatment.

          -  Any prior or ongoing systemic medical condition (including but not limited to
             infectious, inflammatory, psychiatric, neurological, renal, hepatic, respiratory
             conditions or malignancies) or clinically significant screening laboratory value that
             in the opinion of the investigator may present a safety risk, interfere with study
             compliance and follow-up, or confound data interpretation throughout the study period.