Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

NCT03610646 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MYL-1701P-3001
• Study Type: interventional
• Target: 355
• Locations: 9 countries
• Sites: 73

Brief Summary

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema,; BCVA,; ETDRS Letters.

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8

  Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

  Baseline and 8 weeks

Secondary Outcomes (7)

• The Mean Change From Baseline in Central Retinal Thickness (CRT)

  From baseline to week 52

• The Mean Change in BCVA

  From baseline to week 52

• Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA

  From baseline to week 52

• Number of Administrations of Study Drug Required

  From baseline to week 52

• Number of Participants With Treatment Emergent Adverse Events

  From baseline to week 52

Study Arms (2)

MYL-1701P

EXPERIMENTAL

MYL-1701P

Drug: MYL-1701P

Eylea

ACTIVE COMPARATOR

Eylea

Drug: Eylea

Interventions

MYL-1701P DRUG

Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

MYL-1701P

Eylea DRUG

Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

Eylea

Eligibility Criteria

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

You may qualify if:

• Male or female subjects age ≥ 18 years.
• Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
• The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
• Subject is able to understand and voluntarily provide written informed consent to participate in the study.
• If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
• If female, subject must be:
• Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
• Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing at least 90 days following the last treatment.
• Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
• Subject is willing to comply with the study duration, study visits and study related procedures.

You may not qualify if:

• Subjects with known hypersensitivity to aflibercept or any of the excipients
• Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
• Subjects with uncontrolled hypertension defined as systolic blood pressure \>160mm Hg or diastolic blood pressure \> 95 mm of Hg.
• Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
• Subjects with history of use of intraocular corticosteroids anytime in the past or periocular (subconjunctival, intra-scleral, sub-tenon or retrobulbar) corticosteroids within 4 months of randomization
• Subjects who have only one functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead
• Momenta Pharmaceuticals, Inc.: collaborator

Study Sites (73)

Mylan Investigator Site

Phoenix, Arizona, 85014, United States

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Mylan Investigator Site

Phoenix, Arizona, 85020, United States

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Mylan Investigator Site

Sacramento, California, 95841, United States

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St. Petersburg, Florida, 33711, United States

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Winter Haven, Florida, 33880, United States

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Augusta, Georgia, 30909, United States

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Shawnee Mission, Kansas, 66204, United States

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Paducah, Kentucky, 42001, United States

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Chevy Chase, Maryland, 20815, United States

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Ladson, South Carolina, 29456, United States

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Nashville, Tennessee, 37203, United States

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Abilene, Texas, 79606, United States

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Morgantown, West Virginia, 26506, United States

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Prague, Vinohrady, 10034, Czechia

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Hradec Králové, 50005, Czechia

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Olomouc, 77900, Czechia

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Pardubice, 53002, Czechia

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Prague, 12808, Czechia

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Prague, 15000, Czechia

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Zlín, 76275, Czechia

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Göttingen, Lower Saxony, 37075, Germany

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Mainz, Rheinland-Pflaz, 55131, Germany

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Marburg, 35043, Germany

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Budapest, 1076, Hungary

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Budapest, 1106, Hungary

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Debrecen, 4032, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7621, Hungary

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Szeged, 6720, Hungary

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Zalaegerszeg, 8900, Hungary

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Visakhapatnam, Andhra Pradesh, 530040, India

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Ahmedabad, Gujarat, 380015, India

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Ahmedabad, Gujarat, 380016, India

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Bangalore, Karnataka, 560010, India

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Bangalore, Karnataka, 560037, India

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Bangalore, Karnataka, 560094, India

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Mumbai, Maharashtra, 400050, India

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New Delhi, National Capital Territory of Delhi, 110029, India

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Bhubaneswar, Odisha, 751024, India

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Chandigarh, Punjab, 160012, India

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Jaipur, Rajasthan, 302015, India

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Madurai, Tamil Nadu, 625020, India

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Tirunelveli, Tamil Nadu, 627002, India

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Hyderabad, Telangana, 500034, India

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Noida, Uttar Pradesh, 201301, India

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Nagoya, Aichi-ken, 4578510, Japan

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Kōriyama, Fukushima, 9638052, Japan

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Sapporo, Hokkaido, 0608604, Japan

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Mito, Ibaraki, 3100845, Japan

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Yamato, Kanagawa, 2420001, Japan

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Susono, Shizuoka, 4101102, Japan

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Kofu, Yamanashi, 4008506, Japan

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Fukuoka, 8110213, Japan

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Fukushima, 9601295, Japan

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Kagoshima, 8920824, Japan

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Kumamoto, 8600027, Japan

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Nagasaki, 8528501, Japan

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National Hospital Organization Osaka National Hospital

Osaka, 5400006, Japan

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Mylan Investigator Site

Saitama, 3308553, Japan

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Mylan Investigator Site

Jelgava, LV-3001, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1006, Latvia

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Katowice, Silesian Voivodeship, 40594, Poland

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Tarnów, Tarnow, 33100, Poland

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Olsztyn, Warmian-Masurian Voivodeship, 10424, Poland

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Rzeszów, 35017, Poland

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Wałbrzych, 58309, Poland

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Lodz, Łódź Voivodeship, 91134, Poland

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Kazan', Tatarstan Resp., 420012, Russia

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Moscow, 119021, Russia

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Novosibirsk, 630096, Russia

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Mylan Investigator Site

Omsk, 644042, Russia

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Mylan Investigator Site

Saint Petersburg, 197022, Russia

Location

Related Publications (1)

• Bressler SB, Barve A, Ganapathi PC, Beckmann K, Apte RS, Marcus DM, Baumane K, Agarwal S, Oleksy P, Reichstein DA, Patel SS, Ernest J, Degi R, Gupta V, Kishino G, Kamei M, Loganathan S; INSIGHT Study Group. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. 2024 Oct 1;142(10):952-960. doi: 10.1001/jamaophthalmol.2024.3458.

  PMID: 39264599 DERIVED

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Dr. Prasanna Ganapathi, Head of Global Clinical Strategy and Innovation
• Organization: Viatris

prasanna.ganapathi@viatris.com

+91 80 6672800

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masked study drug kits will be supplied to sites as necessary during the study. The outside label of the box will not reveal the identity of the product inside (whether it is Eylea or MYL-1701P) and will be assigned in a masked fashion through the Interactive Response Technology (IRT) system. An un-masked team will identified at site, to be responsible for preparation and administration of the study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 1, 2018
• Study Start: August 23, 2018
• Primary Completion: November 10, 2020
• Study Completion: September 10, 2021
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (7); CZ (7); US (13); RU (5); IN (15); JP (14); DE (3); LA (3); PL (6)