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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03610646
Other study ID # MYL-1701P-3001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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