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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 : September 25, 2018
Sponsor:
Collaborator:
Momenta Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mylan Inc.

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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: MYL-1701P Drug: Eylea Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
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
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
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: MYL-1701P
MYL-1701P
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.


Active Comparator: Eylea
Eylea
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. The mean change in BCVA [ Time Frame: From baseline to week 52 ]
    The mean change in BCVA over time

  3. 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

  4. Number of administrations of study drug required [ Time Frame: From baseline to week 52 ]
    Number of administrations of study drug required

  5. Incidence of treatment emergent adverse events (Safety and tolerability) [ Time Frame: From baseline to week 52 ]
    Incidence of treatment emergent adverse events

  6. 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

  7. Concentration of aflibercept in blood (Pharmacokinetics) [ Time Frame: From baseline to week 52 ]
    Concentration of aflibercept in blood (Pharmacokinetics)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610646


Contacts
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

  Show 23 Study Locations
Sponsors and Collaborators
Mylan Inc.
Momenta Pharmaceuticals, Inc.

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT03610646     History of Changes
Other Study ID Numbers: MYL-1701P-3001
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mylan Inc.:
Diabetic Macular Edema,
BCVA,
ETDRS Letters.

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases