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

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

ClinicalTrials.gov Identifier: NCT04864834

Novartis Reference Number: CSOK583A12301

Last Update: Sep 15, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Neovascular Age-related Macular Degeneration
Phase 
Phase 3
Overall status 
Recruiting
Start date 
May 12, 2021
Completion date 
May 11, 2023
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

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.
Biological
Eylea EU (40 mg/mL)
IVT administration of 2 mg of Eylea 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.

Eligibility Criteria

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

Signed informed consent must be obtained prior to participation in the study
Participants must be 50 years of age or older at Screening
Anti-VEGF treatment-naive patients for either eye and systemically
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
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
BCVA between 73 and 38 letters, both inclusive, in the study eye at Screening and Baseline using ETDRS testing charts
Willing and able to comply with all study procedures, and be likely to complete the study
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:

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
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
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
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
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
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
Retinal pigment epithelium (RPE) rip/tear in the study eye at Screening or Baseline
Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline

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
History of hypersensitivity to any of the study treatments or its excipients, or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigators
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
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
Intra or periocular use of corticosteroids in the study eye within a 6 month period prior to Baseline
Use of topical ocular corticosteroids in the study eye for 30 or more consecutive days within the 90 days period prior to Baseline
Previous therapeutic radiation near the region of the study eye
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
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)
Presence of Scleromalacia in either eye

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

Systemic conditions and treatments:

Previous systemic treatment with any anti-VEGF therapy
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).
Uncontrolled blood pressure defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening
Stroke or myocardial infarction during the 6-month period prior to Baseline
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
Presence of infection at screening or active infection within 2 weeks before screening
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
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.

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).

Study Locations

United States
Sandoz Investigational Site
Recruiting
Phoenix, 85021
Arizona
United States
Sandoz Investigational Site
Recruiting
Arcadia, 91006
California
United States
Sandoz Investigational Site
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Campbell, 95008
California
United States
Sandoz Investigational Site
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Encino, 91436
California
United States
Sandoz Investigational Site
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Fullerton, 92835
California
United States
Sandoz Investigational Site
Recruiting
Glendale, 91203
California
United States
Sandoz Investigational Site
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Huntington Beach, 92647
California
United States
Sandoz Investigational Site
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Pasadena, 91107
California
United States
Sandoz Investigational Site
Recruiting
Poway, 92064
California
United States
Sandoz Investigational Site
Recruiting
Redlands, 92374
California
United States
Sandoz Investigational Site
Recruiting
Sacramento, 95841
California
United States
Sandoz Investigational Site
Recruiting
Coral Springs, 33067
Florida
United States
Sandoz Investigational Site
Recruiting
Fort Myers, 33912-7125
Florida
United States
Sandoz Investigational Site
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Pinellas Park, 33782
Florida
United States
Sandoz Investigational Site
Recruiting
Plantation, 33324
Florida
United States
Sandoz Investigational Site
Recruiting
Stuart, 34994
Florida
United States
Sandoz Investigational Site
Recruiting
Winter Haven, 33880
Florida
United States
Sandoz Investigational Site
Recruiting
Marietta, 30060
Georgia
United States
Sandoz Investigational Site
Recruiting
Oak Forest, 60452
Illinois
United States
Sandoz Investigational Site
Recruiting
Leawood, 66211
Kansas
United States
Sandoz Investigational Site
Recruiting
Hagerstown, 21740
Maryland
United States
Sandoz Investigational Site
Recruiting
Albuquerque, 87102
New Mexico
United States
Sandoz Investigational Site
Recruiting
Great Neck, 11021
New York
United States
Sandoz Investigational Site
Recruiting
Liverpool, 13088
New York
United States
Sandoz Investigational Site
Recruiting
Rochester, 14620
New York
United States
Sandoz Investigational Site
Recruiting
Eugene, 97401
Oregon
United States
Sandoz Investigational Site
Recruiting
Rapid City, 57701
South Dakota
United States
Sandoz Investigational Site
Recruiting
Abilene, 79606
Texas
United States
Sandoz Investigational Site
Recruiting
Arlington, 76012
Texas
United States
Sandoz Investigational Site
Recruiting
San Antonio, 78240
Texas
United States
Sandoz Investigational Site
Recruiting
Willow Park, 70687
Texas
United States
Sandoz Investigational Site
Recruiting
Lynchburg, 24502
Virginia
United States
Australia
Sandoz Investigational Site
Recruiting
Albury, 2640
New South Wales
Australia
Sandoz Investigational Site
Recruiting
Liverpool, 2170
New South Wales
Australia
Sandoz Investigational Site
Recruiting
Parramatta, 2150
New South Wales
Australia
Sandoz Investigational Site
Recruiting
Sydney, 2000
New South Wales
Australia
Sandoz Investigational Site
Recruiting
Adelaide, 5000
South Australia
Australia
Sandoz Investigational Site
Recruiting
Melbourne, 3002
Victoria
Australia
Austria
Sandoz Investigational Site
Recruiting
Linz, A 4020
Oberoesterreich
Austria
Sandoz Investigational Site
Recruiting
Linz, 4021
Upper Austria
Austria
Sandoz Investigational Site
Recruiting
Graz, A-8036
-
Austria
Bulgaria
Sandoz Investigational Site
Recruiting
Sofia, 1784
-
Bulgaria
Sandoz Investigational Site
Recruiting
Varna, 9002
-
Bulgaria
Czech Republic
Sandoz Investigational Site
Recruiting
Pardubice, 530 02
-
Czech Republic
Sandoz Investigational Site
Recruiting
Prague 7, 17000
-
Czech Republic
Sandoz Investigational Site
Recruiting
Praha 5, 150 00
-
Czech Republic
Sandoz Investigational Site
Recruiting
Praha, 12808
-
Czech Republic
France
Sandoz Investigational Site
Recruiting
Marseille, 13008
Bouches-Du-Rhone
France
Sandoz Investigational Site
Recruiting
Saint Cyr sur Loire, 37540
Indre Et Loire
France
Sandoz Investigational Site
Recruiting
Paris, 75015
-
France
Sandoz Investigational Site
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Paris,
-
France
Germany
Sandoz Investigational Site
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Duesseldorf, 40212
-
Germany
Sandoz Investigational Site
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Frankfurt Am Main, 60596
-
Germany
Sandoz Investigational Site
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Freiburg, 79106
-
Germany
Sandoz Investigational Site
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Hannover, 30625
-
Germany
Sandoz Investigational Site
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Leipzig, 04103
-
Germany
Sandoz Investigational Site
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Mainz, 55131
-
Germany
Sandoz Investigational Site
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Marburg, 35043
-
Germany
Sandoz Investigational Site
Recruiting
Muenchen,
-
Germany
Hungary
Sandoz Investigational Site
Recruiting
Budapest, 1204
HUN
Hungary
Sandoz Investigational Site
Recruiting
Budapest, 1134
Pest Megye
Hungary
Sandoz Investigational Site
Recruiting
Budapest, H-1085
-
Hungary
Sandoz Investigational Site
Recruiting
Budapest, H-1136
-
Hungary
Sandoz Investigational Site
Recruiting
Debrecen, 4032
-
Hungary
Sandoz Investigational Site
Recruiting
Sopron, H-9400
-
Hungary
Sandoz Investigational Site
Recruiting
Szeged, H-6720
-
Hungary
Sandoz Investigational Site
Recruiting
Szekesfehervar, H-8000
-
Hungary
Israel
Sandoz Investigational Site
Recruiting
Haifa, 3434104
-
Israel
Sandoz Investigational Site
Recruiting
Jerusalem, 9112001
-
Israel
Sandoz Investigational Site
Recruiting
Kfar Saba, 44281
-
Israel
Sandoz Investigational Site
Recruiting
Lod, 6093000
-
Israel
Sandoz Investigational Site
Recruiting
Petach Tikva, 4941492
-
Israel
Sandoz Investigational Site
Recruiting
Rehovot, 7610001
-
Israel
Sandoz Investigational Site
Recruiting
Tel Aviv, 6423906
-
Israel
Japan
Sandoz Investigational Site
Recruiting
Nagakute-city, 480-1195
Aichi
Japan
Sandoz Investigational Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Sandoz Investigational Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Sandoz Investigational Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Sandoz Investigational Site
Recruiting
Fukuoka-city, 811-0213
Fukuoka
Japan
Sandoz Investigational Site
Recruiting
Fukushima city, 960 1295
Fukushima
Japan
Sandoz Investigational Site
Recruiting
Takasaki-city, 370-0036
Gunma
Japan
Sandoz Investigational Site
Recruiting
Kure, 737-0029
Hiroshima
Japan
Sandoz Investigational Site
Recruiting
Amagasaki city, 660 8550
Hyogo
Japan
Sandoz Investigational Site
Recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Sandoz Investigational Site
Recruiting
Inashiki-gun, 300-0395
Ibaraki
Japan
Sandoz Investigational Site
Recruiting
Kagoshima city, 890 8520
Kagoshima
Japan
Sandoz Investigational Site
Recruiting
Hamamatsu-city, 430-8558
Shizuoka
Japan
Sandoz Investigational Site
Recruiting
Meguro-ku, 152-8902
Tokyo
Japan
Sandoz Investigational Site
Recruiting
Taito-ku, 111-0051
Tokyo
Japan
Sandoz Investigational Site
Recruiting
Ube, 755-8505
Yamaguchi
Japan
Latvia
Sandoz Investigational Site
Recruiting
Riga, 1002
-
Latvia
Sandoz Investigational Site
Recruiting
Riga, LV-1007
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Latvia
Lithuania
Sandoz Investigational Site
Recruiting
Kaunas, 50161
Kauno Apskritis
Lithuania
Sandoz Investigational Site
Recruiting
Vilnius, LT-08661
-
Lithuania
Poland
Sandoz Investigational Site
Recruiting
Krakow, 30-394
Malopolska
Poland
Sandoz Investigational Site
Recruiting
Bydgoszcz, 85-631
-
Poland
Sandoz Investigational Site
Recruiting
Lodz, 91-134
-
Poland
Sandoz Investigational Site
Recruiting
Lublin, 20-079
-
Poland
Sandoz Investigational Site
Recruiting
Wroclaw, 53-334
-
Poland
Portugal
Sandoz Investigational Site
Recruiting
Coimbra, 3000-548
-
Portugal
Sandoz Investigational Site
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Coimbra, 3030-363
-
Portugal
Sandoz Investigational Site
Recruiting
Porto, 4200 319
-
Portugal
Slovakia
Sandoz Investigational Site
Recruiting
Zilina, 010 01
Slovak Republic
Slovakia
Sandoz Investigational Site
Recruiting
Bratislava, 821 01
-
Slovakia
Sandoz Investigational Site
Recruiting
Bratislava, 83301
-
Slovakia
Sandoz Investigational Site
Recruiting
Trencin, 91171
-
Slovakia
Spain
Sandoz Investigational Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Sandoz Investigational Site
Recruiting
Oviedo, 33012
Asturias
Spain
Sandoz Investigational Site
Recruiting
Sant Cugat, 08190
Catalunya
Spain
Sandoz Investigational Site
Recruiting
Pamplona, 31008
Navarra
Spain
Sandoz Investigational Site
Recruiting
Bilbao, 48006
Pais Vasco
Spain
Sandoz Investigational Site
Recruiting
Barcelona, 08021
-
Spain
Sandoz Investigational Site
Recruiting
Barcelona, 8022
-
Spain
Sandoz Investigational Site
Recruiting
Madrid, 28222
-
Spain
Sandoz Investigational Site
Recruiting
Zaragoza, 50009
-
Spain

Contacts

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Phone: 
Name: 
Sandoz
Phone: 

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