A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

NCT04450329 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SB15-3001
• Study Type: interventional
• Target: 449
• Locations: 10 countries
• Sites: 38

Brief Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA)

  The VA was assessed using original series ETDRS charts or 2702 series number charts.

  Baseline and Week 8

Study Arms (2)

SB15 (Proposed aflibercept biosimilar)

EXPERIMENTAL

Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.

Drug: SB15 (Proposed aflibercept biosimilar)

Eylea (Aflibercept)

ACTIVE COMPARATOR

Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.

Drug: SB15 (Proposed aflibercept biosimilar); Drug: Eylea (Aflibercept)

Interventions

SB15 (Proposed aflibercept biosimilar) DRUG

Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.

Eylea (Aflibercept); SB15 (Proposed aflibercept biosimilar)

Eylea (Aflibercept) DRUG

Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.

Eylea (Aflibercept)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years at Screening
• Treatment naïve, \*active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
• The area of CNV must occupy at least 50% of total lesion in the study eye
• Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
• BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts or 2702 series Number charts in the study eye at Screening and at Week 0 (Day 1) prior to randomisation
• Non-childbearing potential female, OR childbearing potential female subjects or male subjects with their (respectively male or female) partners who agree to use at least two forms of appropriate contraception method that can achieve a failure rate of less than 1% per year from Screening until 3 months after the last IVT injection of IP
• Written informed consent form (ICF) must be obtained from the subject prior to any study related procedure
• Willingness and ability to undertake all scheduled visits and assessments

You may not qualify if:

• Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea
• Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea
• Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
• Study eye: Presence of retinal pigment epithelial tears or rips involving the macula
• Study eye: Presence of macular hole at any stage
• Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP
• Study eye: Any concurrent ocular condition which, in the opinion of the Investigator, could either confound the interpretation of efficacy and safety of IP or require medical or surgical intervention during the study period
• Either eye: History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular oedema (DME)
• Study eye: Current vitreous haemorrhage
• Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
• Any previous systemic anti-VEGF treatment
• Study eye: History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD
• Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation. However, dietary supplements, vitamins, or minerals will be allowed.
• Study eye: History of vitrectomy, scleral buckling (encircling), glaucoma filtration surgery, corneal transplantation, or pan-retinal photocoagulation
• Study eye: Previous ocular (intraocular and peribulbar) corticosteroids injection/implant within 1 year prior to randomisation

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (38)

SB Investigative Site

Colorado Springs, Colorado, 80909, United States

Location

SB Investigative Site

Chevy Chase, Maryland, 20815, United States

Location

SB Investigative Site

Abilene, Texas, 79606, United States

Location

SB Investigative Site

Osijek, Croatia

Location

SB Investigative Site

Rijeka, Croatia

Location

SB Investigative Site

Brno, Czechia

Location

SB Investigative Site

Hradec Králové, Czechia

Location

SB Investigative Site

Prague, Czechia

Location

SB Investigative Site

Kohtla-Järve, Estonia

Location

SB Investigative Site

Tallinn, Estonia

Location

SB Investigative Site

Budapest, Hungary

Location

SB Investigative Site

Debrecen, Hungary

Location

SB Investigative Site

Pécs, Hungary

Location

SB Investigative Site

Szeged, Hungary

Location

SB Investigative Site

Zalaegerszeg, Hungary

Location

SB Investigative Site

Aichi, Japan

Location

SB Investigative Site

Fukuoka, Japan

Location

SB Investigative Site

Inashiki-gun, Japan

Location

SB Investigative Site

Kagoshima, Japan

Location

SB Investigative Site

Nagasaki, Japan

Location

SB Investigative Site

Osaka, Japan

Location

SB Investigative Site

Saitama, Japan

Location

SB Investigative Site

Tokyo, Japan

Location

SB Investigative Site

Riga, Latvia

Location

SB Investigative Site

Bydgoszcz, Poland

Location

SB Investigative Site

Katowice, Poland

Location

SB Investigative Site

Krakow, Poland

Location

SB Investigative Site

Lodz, Poland

Location

SB Investigative Site

Tarnów, Poland

Location

SB Investigative Site

Kovrov, Russia

Location

SB Investigative Site

Moscow, Russia

Location

SB Investigative Site

Novosibirsk, Russia

Location

SB Investigative Site

Saint Petersburg, Russia

Location

SB Investigative Site

Ansan, South Korea

Location

SB Investigative Site

Busan, South Korea

Location

SB Investigative Site

Daegu, South Korea

Location

SB Investigative Site

Seongnam, South Korea

Location

SB Investigative Site

Seoul, South Korea

Location

Related Publications (1)

• Woo SJ, Bradvica M, Vajas A, Sagong M, Ernest J, Studnicka J, Veith M, Wylegala E, Patel S, Yun C, Orski M, Astakhov S, Toth-Molnar E, Csutak A, Enyedi L, Kim T, Oh I, Jang H, Sadda SR. Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jul 1;141(7):668-676. doi: 10.1001/jamaophthalmol.2023.2260.

  PMID: 37289448 DERIVED

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd

sbregistry@samsung.com

+82-32-728-0371

Study Officials

• Se Joon Woo

  Seoul National University Bundang Hospital, South Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: June 23, 2020
• Primary Completion: April 15, 2021
• Study Completion: March 16, 2022
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2024-02

Locations

CZ (3); HU (5); KR (5); JP (8); CR (2); PL (5); US (3); RU (4); LA (1); ES (2)