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

• Sponsor: Sandoz (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04864834
• Collaborator: (none)
• Enrollment: 460
• Locations: 119
• Arms: 2
• Anticipated Duration (Months): 26.5
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 460 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
• Anticipated Primary Completion Date: May 5, 2023
• Anticipated Study Completion Date: Jul 28, 2023

Arms and Interventions

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 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. EU: European	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.

Outcome Measures

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. [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. • To evaluate if the anatomical outcome of SOK583A1 is similar to Eylea EU [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. • To evaluate if the anatomical outcome of SOK583A1 is similar to Eylea EU [Week 1, 4, 8, 24 and 52]

   • Mean change of CNV lesion size using FA from Baseline to Week 8 and 52 CNV: Choroidal neovascularization FA: Fundus Angiography

3. • To evaluate if the efficacy of SOK583A1 is similar to Eylea EU in terms of BCVA [Week 24 and 52]

   • Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52

4. • To evaluate if SOK583A1 is similar to Eylea EU in terms of safety [52 weeks]

   • Incidence of ocular and non-ocular Adverse events (AEs) over 52 weeks

5. • To evaluate if SOK583A1 is similar to Eylea EU in terms of immunogenicity [Week 52]

   • Development of binding and neutralizing Anti-drug antibodies (ADAs) up to Week 52

6. • To evaluate the systemic exposure of SOK583A1 and Eylea EU in participants of the Pharmacokinetic (PK) assessment [Baseline (pre-dose) and 24 hours]

   • Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, 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 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

1. History of hypersensitivity to any of the study treatments or its excipients, or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigators

2. 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

3. 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

4. Intra or periocular use of corticosteroids in the study eye within a 6 month period prior to Baseline

5. Use of topical ocular corticosteroids in the study eye for 30 or more consecutive days within the 90 days period prior to Baseline

6. Previous therapeutic radiation near the region of the study eye

7. 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

8. 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)

9. Presence of Scleromalacia in either eye

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

Systemic conditions and treatments:

1. Previous systemic treatment with any anti-VEGF therapy

2. 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).

3. Uncontrolled blood pressure defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening

4. Stroke or myocardial infarction during the 6-month period prior to Baseline

5. 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

6. Presence of infection at screening or active infection within 2 weeks before screening

7. 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

8. 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.

9. 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

Locations

	Site	City	State	Country	Postal Code
1	Sandoz Investigational Site	Phoenix	Arizona	United States	85021
2	Sandoz Investigational Site	Arcadia	California	United States	91006
3	Sandoz Investigational Site	Campbell	California	United States	95008
4	Sandoz Investigational Site	Encino	California	United States	91436
5	Sandoz Investigational Site	Fullerton	California	United States	92835
6	Sandoz Investigational Site	Glendale	California	United States	91203
7	Sandoz Investigational Site	Huntington Beach	California	United States	92647
8	Sandoz Investigational Site	Pasadena	California	United States	91107
9	Sandoz Investigational Site	Poway	California	United States	92064
10	Sandoz Investigational Site	Redlands	California	United States	92374
11	Sandoz Investigational Site	Sacramento	California	United States	95841
12	Sandoz Investigational Site	Fort Myers	Florida	United States	33912-7125
13	Sandoz Investigational Site	Melbourne	Florida	United States	32904
14	Sandoz Investigational Site	Pinellas Park	Florida	United States	33782
15	Sandoz Investigational Site	Plantation	Florida	United States	33324
16	Sandoz Investigational Site	Stuart	Florida	United States	34994
17	Sandoz Investigational Site	Winter Haven	Florida	United States	33880
18	Sandoz Investigational Site	Marietta	Georgia	United States	30060
19	Sandoz Investigational Site	Oak Forest	Illinois	United States	60452
20	Sandoz Investigational Site	Leawood	Kansas	United States	66211
21	Sandoz Investigational Site	Hagerstown	Maryland	United States	21740
22	Sandoz Investigational Site	Albuquerque	New Mexico	United States	87102
23	Sandoz Investigational Site	Great Neck	New York	United States	11021
24	Sandoz Investigational Site	Liverpool	New York	United States	13088
25	Sandoz Investigational Site	Rochester	New York	United States	14620
26	Sandoz Investigational Site	Eugene	Oregon	United States	97401
27	Sandoz Investigational Site	Rapid City	South Dakota	United States	57701
28	Sandoz Investigational Site	Abilene	Texas	United States	79606
29	Sandoz Investigational Site	Arlington	Texas	United States	76012
30	Sandoz Investigational Site	San Antonio	Texas	United States	78240
31	Sandoz Investigational Site	Willow Park	Texas	United States	70687
32	Sandoz Investigational Site	Salt Lake City	Utah	United States	84107
33	Sandoz Investigational Site	Lynchburg	Virginia	United States	24502
34	Sandoz Investigational Site	Waterford	Wisconsin	United States	06385
35	Sandoz Investigational Site	Albury	New South Wales	Australia	2640
36	Sandoz Investigational Site	Liverpool	New South Wales	Australia	2170
37	Sandoz Investigational Site	Parramatta	New South Wales	Australia	2150
38	Sandoz Investigational Site	Sydney	New South Wales	Australia	2000
39	Sandoz Investigational Site	Adelaide	South Australia	Australia	5000
40	Sandoz Investigational Site	Melbourne	Victoria	Australia	3002
41	Sandoz Investigational Site	Linz	Oberoesterreich	Austria	A 4020
42	Sandoz Investigational Site	Linz	Upper Austria	Austria	4021
43	Sandoz Investigational Site	Graz		Austria	A-8036
44	Sandoz Investigational Site	Sofia		Bulgaria	1784
45	Sandoz Investigational Site	Varna		Bulgaria	9002
46	Sandoz Investigational Site	Varna		Bulgaria	9010
47	Sandoz Investigational Site	Pardubice		Czechia	530 02
48	Sandoz Investigational Site	Prague 7		Czechia	17000
49	Sandoz Investigational Site	Praha 5		Czechia	150 00
50	Sandoz Investigational Site	Praha		Czechia	12808
51	Sandoz Investigational Site	Marseille	Bouches-Du-Rhone	France	13008
52	Sandoz Investigational Site	Saint Cyr sur Loire	Indre Et Loire	France	37540
53	Sandoz Investigational Site	Paris		France	75015
54	Sandoz Investigational Site	Paris		France
55	Sandoz Investigational Site	Duesseldorf		Germany	40212
56	Sandoz Investigational Site	Frankfurt Am Main		Germany	60596
57	Sandoz Investigational Site	Freiburg		Germany	79106
58	Sandoz Investigational Site	Hannover		Germany	30625
59	Sandoz Investigational Site	Leipzig		Germany	04103
60	Sandoz Investigational Site	Mainz		Germany	55131
61	Sandoz Investigational Site	Marburg		Germany	35043
62	Sandoz Investigational Site	Muenchen		Germany
63	Sandoz Investigational Site	Neubrandenburg		Germany	17036
64	Sandoz Investigational Site	Budapest	HUN	Hungary	1204
65	Sandoz Investigational Site	Budapest		Hungary	1134
66	Sandoz Investigational Site	Budapest		Hungary	H-1085
67	Sandoz Investigational Site	Budapest		Hungary	H-1136
68	Sandoz Investigational Site	Debrecen		Hungary	4032
69	Sandoz Investigational Site	Sopron		Hungary	H-9400
70	Sandoz Investigational Site	Szeged		Hungary	H-6720
71	Sandoz Investigational Site	Szekesfehervar		Hungary	H-8000
72	Sandoz Investigational Site	Haifa		Israel	3434104
73	Sandoz Investigational Site	Jerusalem		Israel	9112001
74	Sandoz Investigational Site	Kfar Saba		Israel	44281
75	Sandoz Investigational Site	Lod		Israel	6093000
76	Sandoz Investigational Site	Petach Tikva		Israel	4941492
77	Sandoz Investigational Site	Rehovot		Israel	7610001
78	Sandoz Investigational Site	Tel Aviv		Israel	6423906
79	Sandoz Investigational Site	Nagakute-city	Aichi	Japan	480-1195
80	Sandoz Investigational Site	Nagoya	Aichi	Japan	457 8510
81	Sandoz Investigational Site	Nagoya	Aichi	Japan	466 8560
82	Sandoz Investigational Site	Fukuoka city	Fukuoka	Japan	812-8582
83	Sandoz Investigational Site	Fukuoka-city	Fukuoka	Japan	811-0213
84	Sandoz Investigational Site	Fukushima city	Fukushima	Japan	960 1295
85	Sandoz Investigational Site	Takasaki-city	Gunma	Japan	370-0036
86	Sandoz Investigational Site	Kure	Hiroshima	Japan	737-0029
87	Sandoz Investigational Site	Amagasaki city	Hyogo	Japan	660 8550
88	Sandoz Investigational Site	Kobe-shi	Hyogo	Japan	650-0017
89	Sandoz Investigational Site	Inashiki-gun	Ibaraki	Japan	300-0395
90	Sandoz Investigational Site	Kagoshima city	Kagoshima	Japan	890 8520
91	Sandoz Investigational Site	Hamamatsu-city	Shizuoka	Japan	430-8558
92	Sandoz Investigational Site	Meguro-ku	Tokyo	Japan	152-8902
93	Sandoz Investigational Site	Taito-ku	Tokyo	Japan	111-0051
94	Sandoz Investigational Site	Ube	Yamaguchi	Japan	755-8505
95	Sandoz Investigational Site	Riga		Latvia	1002
96	Sandoz Investigational Site	Riga		Latvia	LV-1007
97	Sandoz Investigational Site	Kaunas	Kauno Apskritis	Lithuania	50161
98	Sandoz Investigational Site	Vilnius		Lithuania	LT-08661
99	Sandoz Investigational Site	Krakow	Malopolska	Poland	30-394
100	Sandoz Investigational Site	Bydgoszcz		Poland	85-631
101	Sandoz Investigational Site	Lodz		Poland	91-134
102	Sandoz Investigational Site	Lublin		Poland	20-079
103	Sandoz Investigational Site	Wroclaw		Poland	53-334
104	Sandoz Investigational Site	Coimbra		Portugal	3000-548
105	Sandoz Investigational Site	Coimbra		Portugal	3030-363
106	Sandoz Investigational Site	Porto		Portugal	4200 319
107	Sandoz Investigational Site	Zilina	Slovak Republic	Slovakia	010 01
108	Sandoz Investigational Site	Bratislava		Slovakia	821 01
109	Sandoz Investigational Site	Bratislava		Slovakia	83301
110	Sandoz Investigational Site	Trencin		Slovakia	91171
111	Sandoz Investigational Site	Sevilla	Andalucia	Spain	41009
112	Sandoz Investigational Site	Oviedo	Asturias	Spain	33012
113	Sandoz Investigational Site	Sant Cugat	Catalunya	Spain	08190
114	Sandoz Investigational Site	Pamplona	Navarra	Spain	31008
115	Sandoz Investigational Site	Bilbao	Pais Vasco	Spain	48006
116	Sandoz Investigational Site	Barcelona		Spain	08021
117	Sandoz Investigational Site	Barcelona		Spain	8022
118	Sandoz Investigational Site	Madrid		Spain	28222
119	Sandoz Investigational Site	Zaragoza		Spain	50009

Sponsors and Collaborators

• Sandoz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sandoz
• ClinicalTrials.gov Identifier: NCT04864834
• Other Study ID Numbers: CSOK583A12301
• First Posted: Apr 29, 2021
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration

Study Results

No Results Posted as of Apr 20, 2022