Clinical trial NCT03610646: Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
Official title: A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema,
BCVA,
ETDRS Letters.
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Momenta Pharmaceuticals, Inc.
First posted: 2018-08-01
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

Detailed description: 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®. Subjects to receive the assigned treatment until Week 48.

All subjects to return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. Additional visits allowed during the study as specified in the study schedule for safety and pharmacokinetic evaluation.

Pharmacokinetics (PK) and Immunogenicity to be assessed in the subjects participating in the study.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects age ≥ 18 years.
2. Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
3. The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
4. Subject is able to understand and voluntarily provide written informed consent to participate in the study.
5. 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.
6. If female, subject must be:

   1. Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
   2. 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.
   3. Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
7. If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose.
8. Subject is willing to comply with the study duration, study visits and study related procedures.

Exclusion Criteria:

1. Subjects with known hypersensitivity to aflibercept or any of the excipients
2. 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
3. Subjects with uncontrolled hypertension defined as systolic blood pressure \>160mm Hg or diastolic blood pressure \> 95 mm of Hg.
4. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
5. 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
6. 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.

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: The Mean Change From Baseline in Central Retinal Thickness (CRT)
timeFrame: From baseline to week 52
measure: The Mean Change in BCVA
timeFrame: From baseline to week 52
measure: Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA
timeFrame: From baseline to week 52
measure: Number of Administrations of Study Drug Required
timeFrame: From baseline to week 52
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From baseline to week 52
measure: Number of Subjects With Induced and Boosted Anti-Drug Antibodies
timeFrame: From baseline to week 52
measure: Concentration of Aflibercept in Blood (Pharmacokinetics)
timeFrame: 2 Days after Week 16 Injection
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mylan Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Mylan Investigator Site
state: Arizona
city: Sacramento
country: United States
facility: Mylan Investigator Site
state: California
city: Saint Petersburg
country: United States
facility: Mylan Investigator Site
state: Florida
city: Winter Haven
country: United States
facility: Mylan Investigator Site
state: Florida
city: Augusta
country: United States
facility: Mylan Investigator Site
state: Georgia
city: Shawnee Mission
country: United States
facility: Mylan Investigator Site
state: Kansas
city: Paducah
country: United States
facility: Mylan Investigator Site
state: Kentucky
city: Chevy Chase
country: United States
facility: Mylan Investigator Site
state: Maryland
city: Ladson
country: United States
facility: Mylan Investigator Site
state: South Carolina
city: Nashville
country: United States
facility: Mylan Investigator Site
state: Tennessee
city: Abilene
country: United States
facility: Mylan Investigator Site
state: Texas
city: Morgantown
country: United States
facility: Mylan Investigator Site
state: West Virginia
city: Praha 10
country: Czechia
facility: Mylan Investigator Site
state: Vinohrady
city: Hradec Králové
country: Czechia
facility: Mylan Investigator Site
city: Olomouc
country: Czechia
facility: Mylan Investigator Site
city: Pardubice
country: Czechia
facility: Mylan Investigator Site
city: Praha 2
country: Czechia
facility: Mylan Investigator Site
city: Praha 5
country: Czechia
facility: Mylan Investigator Site
city: Zlín
country: Czechia
facility: Mylan Investigator Site
city: Göttingen
country: Germany
facility: Mylan Investigator Site
state: Lower Saxony
city: Mainz
country: Germany
facility: Mylan Investigator Site
state: Rheinland-Pflaz
city: Marburg
country: Germany
facility: Mylan Investigator Site
city: Budapest
country: Hungary
facility: Mylan Investigator Site
city: Budapest
country: Hungary
facility: Mylan Investigator Site
city: Debrecen
country: Hungary
facility: Mylan Investigator Site
city: Nyíregyháza
country: Hungary
facility: Mylan Investigator Site
city: Pecs
country: Hungary
facility: Mylan Investigator Site
city: Szeged
country: Hungary
facility: Mylan Investigator Site
city: Zalaegerszeg
country: Hungary
facility: Mylan Investigator Site
city: Visakhapatnam
country: India
facility: Mylan Investigator Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Mylan Investigator Site
state: Delhi
city: Ahmedabad
country: India
facility: Mylan Investigator Site
state: Gujarat
city: Ahmedabad
country: India
facility: Mylan Investigator Site
state: Gujarat
city: Bangalore
country: India
facility: Mylan Investigator Site
state: Karnataka
city: Bangalore
country: India
facility: Mylan Investigator site
state: Karnataka
city: Bangalore
country: India
facility: Mylan Investigator Site
state: Karnataka
city: Mumbai
country: India
facility: Mylan Investigator Site
state: Maharashtra
city: Bhubaneswar
country: India
facility: Mylan Investigator Site
state: Orissa
city: Chandigarh
country: India
facility: Mylan Investigator Site
state: Punjab
city: Jaipur
country: India
facility: Mylan Investigator Site
state: Rajasthan
city: Madurai
country: India
facility: Mylan Investigator Site
state: Tamilnadu
city: Tirunelveli
country: India
facility: Mylan Investigator Site
state: Tamilnadu
city: Hyderabad
country: India
facility: Mylan Investigator Site
state: Telangana
city: Noida
country: India
facility: Mylan Investigator Site
state: Uttar Pradesh
city: Nagoya
country: Japan
facility: Mylan Investigator Site
state: Aichi
city: Koriyama
country: Japan
facility: Mylan Investigator Site
state: Fukushima
city: Sapporo
country: Japan
facility: Mylan Investigator Site
state: Hokkaido
city: Mito
country: Japan
facility: Mylan Investigator Site
state: Ibaraki
city: Yamato
country: Japan
facility: Mylan Investigator Site
state: Kanagawa
city: Susono
country: Japan
facility: Mylan Investigator Site
state: Shizuoka
city: Kōfu
country: Japan
facility: Mylan Investigator Site
state: Yamanashi
city: Fukuoka
country: Japan
facility: Mylan Investigator Site
city: Fukushima
country: Japan
facility: Mylan Investigator Site
city: Kagoshima
country: Japan
facility: Mylan Investigator Site
city: Kumamoto
country: Japan
facility: Mylan Investigator Site
city: Nagasaki
country: Japan
facility: Mylan Investigator Site
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Saitama
country: Japan
facility: Mylan Investigator Site
city: Jelgava
country: Latvia
facility: Mylan Investigator Site
city: Riga
country: Latvia
facility: Mylan Investigator Site
city: Riga
country: Latvia
facility: Mylan Investigator Site
city: Łódź
country: Poland
facility: Mylan Investigator Site
state: Lodzkie
city: Katowice
country: Poland
facility: Mylan Investigator Site
state: Slaskie
city: Tarnów
country: Poland
facility: Mylan Investigator Site
state: Tarnow
city: Olsztyn
country: Poland
facility: Mylan Investigator Site
state: Warminsko-Mazurskie
city: Rzeszów
country: Poland
facility: Mylan Investigator Site
city: Wałbrzych
country: Poland
facility: Mylan Investigator Site
city: Kazan
country: Russian Federation
facility: Mylan Investigator Site
state: Tatarstan Resp.
city: Moscow
country: Russian Federation
facility: Mylan Investigator Site
city: Novosibirsk
country: Russian Federation
facility: Mylan Investigator Site
city: Omsk
country: Russian Federation
facility: Mylan Investigator Site
city: Saint Petersburg
country: Russian Federation
facility: Mylan Investigator Site
Study officials:
References: