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

Diabetic Macular Edema Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610646
• Other study ID #: MYL-1701P-3001
• Status: Completed
• Phase: Phase 3
• Start date: August 23, 2018
• Est. completion date: September 10, 2021

Study information

• Verified date: February 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: September 10, 2021
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• MYL-1701P
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.
• Eylea
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.

Locations

Country	Name	City	State
Czechia	Mylan Investigator Site	Hradec Králové
Czechia	Mylan Investigator Site	Olomouc
Czechia	Mylan Investigator Site	Pardubice
Czechia	Mylan Investigator Site	Praha 10	Vinohrady
Czechia	Mylan Investigator Site	Praha 2
Czechia	Mylan Investigator Site	Praha 5
Czechia	Mylan Investigator Site	Zlín
Germany	Mylan Investigator Site	Göttingen	Lower Saxony
Germany	Mylan Investigator Site	Mainz	Rheinland-Pflaz
Germany	Mylan Investigator Site	Marburg
Hungary	Mylan Investigator Site	Budapest
Hungary	Mylan Investigator Site	Budapest
Hungary	Mylan Investigator Site	Debrecen
Hungary	Mylan Investigator Site	Nyíregyháza
Hungary	Mylan Investigator Site	Pecs
Hungary	Mylan Investigator Site	Szeged
Hungary	Mylan Investigator Site	Zalaegerszeg
India	Mylan Investigator Site	Ahmedabad	Gujarat
India	Mylan Investigator Site	Ahmedabad	Gujarat
India	Mylan Investigator Site	Bangalore	Karnataka
India	Mylan Investigator site	Bangalore	Karnataka
India	Mylan Investigator Site	Bangalore	Karnataka
India	Mylan Investigator Site	Bhubaneswar	Orissa
India	Mylan Investigator Site	Chandigarh	Punjab
India	Mylan Investigator Site	Hyderabad	Telangana
India	Mylan Investigator Site	Jaipur	Rajasthan
India	Mylan Investigator Site	Madurai	Tamilnadu
India	Mylan Investigator Site	Mumbai	Maharashtra
India	Mylan Investigator Site	New Delhi	Delhi
India	Mylan Investigator Site	Noida	Uttar Pradesh
India	Mylan Investigator Site	Tirunelveli	Tamilnadu
India	Mylan Investigator Site	Visakhapatnam	Andhra Pradesh
Japan	Mylan Investigator Site	Fukuoka
Japan	Mylan Investigator Site	Fukushima
Japan	Mylan Investigator Site	Kagoshima
Japan	Mylan Investigator Site	Kofu	Yamanashi
Japan	Mylan Investigator Site	Koriyama	Fukushima
Japan	Mylan Investigator Site	Kumamoto
Japan	Mylan Investigator Site	Mito	Ibaraki
Japan	Mylan Investigator Site	Nagasaki
Japan	Mylan Investigator Site	Nagoya	Aichi
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Mylan Investigator Site	Saitama
Japan	Mylan Investigator Site	Sapporo	Hokkaido
Japan	Mylan Investigator Site	Susono	Shizuoka
Japan	Mylan Investigator Site	Yamato	Kanagawa
Latvia	Mylan Investigator Site	Jelgava
Latvia	Mylan Investigator Site	Riga
Latvia	Mylan Investigator Site	Riga
Poland	Mylan Investigator Site	Katowice	Slaskie
Poland	Mylan Investigator Site	Lódz	Lodzkie
Poland	Mylan Investigator Site	Olsztyn	Warminsko-Mazurskie
Poland	Mylan Investigator Site	Rzeszów
Poland	Mylan Investigator Site	Tarnów	Tarnow
Poland	Mylan Investigator Site	Walbrzych
Russian Federation	Mylan Investigator Site	Kazan	Tatarstan Resp.
Russian Federation	Mylan Investigator Site	Moscow
Russian Federation	Mylan Investigator Site	Novosibirsk
Russian Federation	Mylan Investigator Site	Omsk
Russian Federation	Mylan Investigator Site	Saint Petersburg
United States	Mylan Investigator Site	Abilene	Texas
United States	Mylan Investigator Site	Augusta	Georgia
United States	Mylan Investigator Site	Chevy Chase	Maryland
United States	Mylan Investigator Site	Ladson	South Carolina
United States	Mylan Investigator Site	Morgantown	West Virginia
United States	Mylan Investigator Site	Nashville	Tennessee
United States	Mylan Investigator Site	Paducah	Kentucky
United States	Mylan Investigator Site	Phoenix	Arizona
United States	Mylan Investigator Site	Phoenix	Arizona
United States	Mylan Investigator Site	Sacramento	California
United States	Mylan Investigator Site	Saint Petersburg	Florida
United States	Mylan Investigator Site	Shawnee Mission	Kansas
United States	Mylan Investigator Site	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Pharmaceuticals Inc	Momenta Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Hungary,  India,  Japan,  Latvia,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Mean Change From Baseline in Central Retinal Thickness (CRT)	The mean change from baseline in Central Retinal Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) over time	From baseline to week 52
Secondary	The Mean Change in BCVA	Mean change from baseline in BCVA as assessed by ETDRS letters over time. 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	From baseline to week 52
Secondary	Number of Subjects Who Gained =15 Letters From Baseline in BCVA	Number of subjects who gained =15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time	From baseline to week 52
Secondary	Number of Administrations of Study Drug Required	The mean number of doses administered during the 52 weeks of study	From baseline to week 52
Secondary	Number of Participants With Treatment Emergent Adverse Events	Number of Participants with Treatment Emergent Adverse Events (Safety and tolerability)	From baseline to week 52
Secondary	Number of Subjects With Induced and Boosted Anti-Drug Antibodies	Number of subjects with induced and boosted Anti-Drug Antibodies (ADA) (Immunogenicity)	From baseline to week 52
Secondary	Concentration of Aflibercept in Blood (Pharmacokinetics)	Free Drug Concentration of aflibercept in blood (Pharmacokinetics)	2 Days after Week 16 Injection