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Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (Mylight)

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ClinicalTrials.gov Identifier: NCT04864834
Recruitment Status : Completed
First Posted : April 29, 2021
Results First Posted : March 26, 2024
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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Brief Summary:

Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD.

The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?


Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Biological: SOK583A1 (40 mg/mL) Biological: Eylea EU (40 mg/mL) Phase 3

Detailed Description:
BCVA: Best-Corrected Visual Acuity Eylea EU: Europe-authorized Eylea® nAMD: Neovascular Age-related Macular Degeneration VEGF: Vascular Endothelium Growth Factor
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea®, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration
Actual Study Start Date : May 12, 2021
Actual Primary Completion Date : July 7, 2022
Actual Study Completion Date : May 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SOK583A1 (40 mg/mL)
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
 Biological: SOK583A1 (40 mg/mL)
IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
Active Comparator: Eylea EU (40 mg/mL)

IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.

EU: European

 Biological: Eylea EU (40 mg/mL)
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.


Outcome Measures
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Primary Outcome Measures :
  1. Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline. [ Time Frame: Change from baseline in mean BCVA score at Week 8 ]

    The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence.

    ETDRS: Early Treatment Diabetic Retinopathy Study EU: European



Secondary Outcome Measures :
  1. Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU [ Time Frame: Week 1, 4, 8, 24 and 52 ]

    Mean change in CSFT using SD-OCT from Baseline to Week 1, 4, 8, 24 and 52

    CSFT: Central Subfield Thickness SD-OCT: Spectral-Domain Optical Coherence Tomography


  2. Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU [ Time Frame: Week 8 and 52 ]

    Mean change of CNV lesion size using FA from Screening to Week 8 and 52

    CNV: Choroidal neovascularization FA: Fundus Angiography


  3. Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA [ Time Frame: Week 24 and 52 ]
    Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52

  4. Similarity Between SOK583A1 and Eylea EU in Terms of Safety [ Time Frame: 52 weeks ]
    Number and proportion of subjects with ocular and non-ocular Adverse Events (AEs) over 52 weeks including serious AEs, regardless of relationship to study treatment

  5. Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity [ Time Frame: Week 52 ]
    Development of binding and neutralizing Anti-drug antibodies (ADAs) up to Week 52

  6. Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment [ Time Frame: Baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58) ]
    Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections


Other Outcome Measures:
  1. Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept [ Time Frame: Assessment at Week 48 (pre-dose) and Week 52 ]
    Mean VEGF concentrations


Eligibility Criteria
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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

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Signed informed consent must be obtained prior to participation in the study
  2. Participants must be 50 years of age or older at Screening
  3. Anti-VEGF treatment-naive patients for either eye and systemically
  4. Study eye diagnosed with active CNV lesions (type 1 and/ or type 2) secondary to AMD and/or Retinal Angiomatous Proliferation lesions (type 3), affecting the central subfield. Active CNV lesion is defined by the presence of leakage as evidenced by fluorescein angiography, and intra- or subretinal fluid as evidenced by optical coherence tomography, both confirmed by the CRC at Screening
  5. Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye, confirmed by the CRC at Screening
  6. BCVA between 73 and 38 letters, both inclusive, in the study eye at Screening and Baseline using ETDRS testing charts
  7. Willing and able to comply with all study procedures, and be likely to complete the study
  8. Clear ocular media and adequate pupil dilatation in both eyes to permit good quality photographic imaging.

Participants meeting any of the following criteria are not eligible for inclusion in this study.

Ocular conditions and treatments:

  1. Previous treatment with any anti-VEGF therapy in either eye or investigational drugs in study eye or fellow eye, at any time prior to Baseline
  2. Participant has received any approved treatment for nAMD (other than vitamin and dietary supplements) in the study eye and at any time prior to Baseline
  3. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative), ocular histoplasmosis syndrome, angioid streaks,choroidal rupture, or multifocal choroiditis in the study eye, assessed by imaging at screening by CRC and appropriately stated in the multi-modal eligibility confirmation report
  4. Any active or suspected intraocular or periocular infection or suspected active intraocular inflammation (e.g infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in either eye at Screening or Baseline
  5. Subfoveal fibrosis, atrophy, or scarring extending > 50% of total lesion area in the study eye as assessed by the Investigator at Screening and confirmed by the CRC prior to randomization
  6. Subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involving the fovea is 1 or more disc areas (≥ 2.54 mm2 ) in size in the study eye, as assessed by Fluorescein Angiography (FA) and confirmed by the CRC
  7. Retinal pigment epithelium (RPE) rip/tear in the study eye at Screening or Baseline
  8. Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline

  9. History or evidence of the following, in the study eye:

    • Intraocular (including cataract surgery) or refractive surgery within the 90 day period prior to Baseline. The yttrium aluminum garnet (YAG) posterior capsulotomy is allowed no later than 4 weeks prior to Baseline
    • Previous penetrating keratoplasty or vitrectomy
    • Previous panretinal photocoagulation
    • Previous photodynamic therapy
    • Previous submacular surgery or other surgical intervention for AMD
    • Retinal detachment or treatment or surgery for retinal detachment
    • Any history of macular hole of stage 2 and above
    • Prior trabeculectomy or other filtration surgery
    • Ocular trauma within the 6-months period prior to Baseline
  10. History of hypersensitivity to any of the study treatments or its excipients, or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigators
  11. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator's judgment at Screening or Baseline
  12. Aphakia and/or absence of the posterior capsule in the study eye at Screening or Baseline, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
  13. Intra or periocular use of corticosteroids in the study eye within a 6 month period prior to Baseline
  14. Use of topical ocular corticosteroids in the study eye for 30 or more consecutive days within the 90 days period prior to Baseline
  15. Previous therapeutic radiation near the region of the study eye
  16. Concomitant conditions or ocular disorders in the study eye, including media opacities, cataract and diabetic macular edema, at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results (efficacy and safety), compromise visual acuity or require medical or surgical intervention during the course of the study
  17. Presence of amblyopia, amaurosis or ocular disorders with BCVA <38 letters (ETDRS testing charts) in the fellow eye at Screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
  18. Presence of Scleromalacia in either eye

  19. Participants requiring anti-VEGF treatment of the fellow eye at Baseline will not be eligible for the PK substudy

    Systemic conditions and treatments:

  20. Previous systemic treatment with any anti-VEGF therapy
  21. Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to Baseline, with the exception of low stable doses of corticosteroids (defined as ≤ 10 mg prednisolone or equivalent dose used for 90 days or more).
  22. Uncontrolled blood pressure defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening
  23. Stroke or myocardial infarction during the 6-month period prior to Baseline
  24. Participation in an investigational systemic drug, biologic, or device study within 30 days or duration of 5 half-lives of the investigational product (whichever is longer) prior to Baseline. Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary
  25. Presence of infection at screening or active infection within 2 weeks before screening
  26. Underlying advanced, severe and uncontrolled concomitant condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, inflammatory, infectious or gastrointestinal), physical examination finding, or clinical laboratory finding which in the opinion of the Investigator place the participant at unacceptable risk from participation in the study
  27. History of a medical condition (including, but not limited to chronic disease immunosuppression, metabolic dysfunction, prior exposure to other drugs that may pose risk of infection or allergic reactions) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product, or that might affect participant safety or interpretation of the study results.

  28. Pregnant or nursing (lactating) women and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping the medication. Highly effective contraception methods include:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    • Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
    • Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04864834


Locations
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Sponsors and Collaborators
Sandoz
  Study Documents (Full-Text)

Documents provided by Sandoz:
Study Protocol  [PDF] June 28, 2022
Statistical Analysis Plan  [PDF] June 22, 2023

More Information
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT04864834    
Other Study ID Numbers: CSOK583A12301
First Posted: April 29, 2021    Key Record Dates
Results First Posted: March 26, 2024
Last Update Posted: March 26, 2024
Last Verified: July 2023
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
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases