Phase 3 study assessing the efficacy, safety and immunogenicity of SOK583A1 versus Eylea in patients with neovascular age related macular degeneration

JRCT ID: jRCT2031210120

Registered date:28/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: neovascular age-related macular degeneration
• Date of first enrollment: 02/11/2021
• Target sample size: 460
• Countries of recruitment: Australia,Japan,Bulgaria,Japan,the Czech Republic,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Latvia,Japan,Lithuania,Japan,Poland,Japan,Romania,Japan,Russia,Japan,Slovakia,Japan,Spain,Japan,Ukraine,Japan,the United States,Japan,Austria,Japan,New Zealand,Japan,Portugal,Japan
• Study type: Interventional
• Intervention(s): SOK583A1 2mg or Eylea EU 2mg, IVT administration

Outcome(s)

Primary Outcome

1 Mean change from baseline in BCVA score
using ETDRS testing charts at Week 8
2 Spectral Domain Optical Coherence Tomography (SD-OCT)
3 Color fundus photography and fluorescein angiography

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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 the Baseline
3. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of 8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye
4. Any active or suspected intraocular or periocular infection or active or suspected 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 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
1)Intraocular (including cataract surgery) or refractive surgery within the 90 day periodprior to Baseline. The yttrium aluminum garnet (YAG) posterior capsulotomy is allowed no later than 4 weeks prior to Baseline
2)Previous penetrating keratoplasty or vitrectomy
3)Previous panretinal photocoagulation
4)Previous photodynamic therapy
5)Previous submacular surgery or other surgical intervention for AMD
6)Retinal detachment or treatment or surgery for retinal detachment
7)Any history of macular hole of stage 2 and above
8)Prior trabeculectomy or other filtration surgery
9)Ocular trauma within 6 months 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 Investigator
11. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator 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 prior to Baseline).
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
1)Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
2)Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 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.
3)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.
4)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).

Related Information

• Primary Sponsor: Kobayashi Takeshi