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

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ClinicalTrials.gov Identifier: NCT03610646
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Momenta Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mylan Inc.

Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE August 23, 2018
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
The mean change from baseline in BCVA at week 8 [ Time Frame: From baseline to week 8 ]
The mean change from baseline in BCVA as assessed by ETDRS letters at week 8
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03610646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • The mean change from baseline in CRT [ Time Frame: From baseline to week 52 ]
    The mean change from baseline in CRT as determined by SD-OCT over time
  • The mean change in BCVA [ Time Frame: From baseline to week 52 ]
    The mean change in BCVA over time
  • Proportion of subjects who gained ≥15 letters from Baseline in BCVA [ Time Frame: From baseline to week 52 ]
    Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
  • Number of administrations of study drug required [ Time Frame: From baseline to week 52 ]
    Number of administrations of study drug required
  • Incidence of treatment emergent adverse events (Safety and tolerability) [ Time Frame: From baseline to week 52 ]
    Incidence of treatment emergent adverse events
  • Proportion of subjects testing positive for Anti-Drug Antibodies (ADA) (Immunogenicity) [ Time Frame: From baseline to week 52 ]
    Proportion of subjects testing positive for Anti-Drug Antibodies
  • Concentration of aflibercept in blood (Pharmacokinetics) [ Time Frame: From baseline to week 52 ]
    Concentration of aflibercept in blood (Pharmacokinetics)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • The mean change from baseline in CRT [ Time Frame: From baseline to week 52 ]
    The mean change from baseline in CRT as determined by SD-OCT over time
  • The mean change in BCVA [ Time Frame: From baseline to week 52 ]
    The mean change in BCVA over time
  • Proportion of subjects who gained ≥15 letters from Baseline in BCVA [ Time Frame: From baseline to week 52 ]
    Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
  • Number of administrations of study drug required [ Time Frame: From baseline to week 52 ]
    Number of administrations of study drug required
  • Incidence of treatment emergent adverse events (Safety and tolerability) [ Time Frame: From baseline to week 52 ]
    Incidence of treatment emergent adverse events
  • Proportion of subjects testing positive for Anti-Drug Antibodies (ADA) (Immunogenicity) [ Time Frame: From baseline to week 52 ]
    Proportion of subjects testing positive for Anti-Drug Antibodies
  • Pharmacokinetics [ Time Frame: From baseline to week 52 ]
    Concentration of aflibercept (free drug) in PK subpopulation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema
Official Title  ICMJE 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
Brief Summary

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement will be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.

The primary endpoint will be mean change from baseline in BCVA as assessed by ETDRS letters. Pharmacokinetics (PK) and immunogenicity will 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 will be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects will receive the assigned treatment until Week 48.

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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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 IRT system. An un-masked team will identified at site, to be responsible for preparation and administration of the study drug.
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • 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.

  • Drug: 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.

Study Arms  ICMJE
  • Experimental: MYL-1701P
    MYL-1701P
    Intervention: Drug: MYL-1701P
  • Active Comparator: Eylea
    Eylea
    Intervention: Drug: Eylea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2018)
324
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 21, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Prasanna C Ganapathi, MD +91-80 667 28859 ext 28952 PrasannaC.Ganapathi@mylan.in
Contact: Rajesh S Nachankar, Ph. D. +91-80 667 28859 ext 28951 rajesh.nachankar@mylan.in
Listed Location Countries  ICMJE Czechia,   Germany,   Hungary,   Japan,   Latvia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03610646
Other Study ID Numbers  ICMJE MYL-1701P-3001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mylan Inc.
Study Sponsor  ICMJE Mylan Inc.
Collaborators  ICMJE Momenta Pharmaceuticals, Inc.
Investigators  ICMJE Not Provided
PRS Account Mylan Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP