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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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.


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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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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

  Hide Study Locations
Locations
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United States, Arizona
Retinal Consultants Of Arizona, Ltd. Recruiting
Phoenix, Arizona, United States, 85014
Associated Retina Consultants Recruiting
Phoenix, Arizona, United States, 85020
United States, California
Retinal Diagnostic Center Active, not recruiting
Campbell, California, United States, 95008
Retinal Consultants Medical Group, Recruiting
Sacramento, California, United States, 95841
United States, Connecticut
Retina Group of New England Withdrawn
Waterford, Connecticut, United States, 06385
United States, Florida
Retina Vitreous Associates of Florida (RVA), Recruiting
Saint Petersburg, Florida, United States, 33711
Center for Retina and Macular Disease Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Southeast Retina Center, Recruiting
Augusta, Georgia, United States, 30909
United States, Kansas
Retina Associates, Recruiting
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Paducah Retinal Center, Active, not recruiting
Paducah, Kentucky, United States, 42001
United States, Maryland
Retina Group Of Washington, Recruiting
Chevy Chase, Maryland, United States, 20815
Retina Specialists, Withdrawn
Towson, Maryland, United States, 21204
United States, Minnesota
Retina Consultants Of Michigan Withdrawn
Minneapolis, Minnesota, United States, 55435
United States, Nebraska
University Of Nebraska Medical Center, Withdrawn
Omaha, Nebraska, United States, 68198
United States, Nevada
Retina Consultants of Nevada Not yet recruiting
Las Vegas, Nevada, United States, 89144
United States, New Jersey
NJ Retina Not yet recruiting
Edison, New Jersey, United States, 08820
United States, New York
Ophthalmic Consultants Of Long Island Recruiting
Lynbrook, New York, United States, 11563
United States, South Carolina
Charleston Neuroscience Institute Recruiting
Ladson, South Carolina, United States, 29456
United States, Tennessee
Tennessee Retina, Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Retina Research Institute Of Texas Recruiting
Abilene, Texas, United States, 79606
Retina Consultants Houston, Not yet recruiting
Houston, Texas, United States, 77030
United States, Virginia
Retina Institute of Virginia Withdrawn
Richmond, Virginia, United States, 23235
Virginia Retina Center, Not yet recruiting
Warrenton, Virginia, United States, 20186
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Czechia
Fakultni nemocnice Kralovske Vinohrady Recruiting
Praha 10, Vinohrady, Czechia, 10034
Fakultní Nemocnice Hradec Králové, Recruiting
Hradec Králové, Czechia, 50005
Fakultni nemocnice Olomouc Recruiting
Olomouc, Czechia, 77900
Fakultni nemocnice Ostrava Not yet recruiting
Ostrava-Poruba, Czechia, 70852
OFTEX Ocni klinika Recruiting
Pardubice, Czechia, 53002
Ocni klinika, Vseobecna Fakultni nemocnice v Praze a 1 Recruiting
Praha 2, Czechia, 12808
Axon Clinical s.r.o., Recruiting
Praha 5, Czechia, 15000
Gemini Not yet recruiting
Příluky, Czechia, 76001
Krajska Nemocnice T. Bati a.s. (KNTB) Recruiting
Zlín, Czechia, 76275
Germany
Universitaetsmedizin Göttingen Recruiting
Göttingen, Lower Saxony, Germany, 37075
Universitätsklinikum Köln Not yet recruiting
Cologne, North Rhine-Westphal, Germany, 50937
MVZ Augenaerztliches Diagnostik- & Therapiezentrum Siegburg, Not yet recruiting
Siegburg, North Rhine-Westphal, Germany, 53721
Universitaetsmedizin Mainz Recruiting
Mainz, Rheinland-Pflaz, Germany, 55131
Mylan Investigator Site Not yet recruiting
Dresden, Saxony, Germany, 01067
Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 12203
University of Leubeck, Department of Ophthalmology Not yet recruiting
Leubeck, Germany, 23538
Philipps-Universitaet Marburg Recruiting
Marburg, Germany, 35043
Universitaetsklinikum Regensburg, Withdrawn
Regensburg, Germany, 93053
Hungary
Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet Recruiting
Budapest, Hungary, 1076
Bajcsy-Zsilinszky Korhaz es Rendelointezet Recruiting
Budapest, Hungary, 1106
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak Not yet recruiting
Budapest, Hungary, 1125
Budapest Retina Associates Kft. Not yet recruiting
Budapest, Hungary, 1133
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hungary, 4032
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz Recruiting
Nyíregyháza, Hungary, 4400
Ganglion Orvosi Kozpont Recruiting
Pecs, Hungary, 7621
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Recruiting
Szeged, Hungary, 6720
Zala Megyei Szent Rafael Korhaz, Recruiting
Zalaegerszeg, Hungary, 8900
Japan
Aichi Medical University Hospital Not yet recruiting
Nagakute, Aichi, Japan, 4801195
Japan Community Healthcare Organization Chukyo Hospital Not yet recruiting
Nagoya, Aichi, Japan, 4578510
Juntendo University Urayasu Hospital Not yet recruiting
Urayasu, Chiba, Japan, 2790021
Fukuoka University Chikushi Hospital Not yet recruiting
Chikushino, Fukuoka, Japan, 8188502
Murakamikarindoh Hospital Withdrawn
Fukuoka-city, Fukuoka, Japan, 819-8585
Sapporo City General Hospital Not yet recruiting
Sapporo, Hokkaido, Japan, 0608604
Hyogo Prefectural Amagasaki General Medical Center Not yet recruiting
Amagasaki, Hyogo, Japan, 6608550
Kozawa eye hospital and diabetes center Recruiting
Mito, Ibaraki, Japan, 3100845
Otake Eye Clinic Tsukimino Not yet recruiting
Yamato, Kanagawa, Japan, 2420001
Ageo Central General Hospital Withdrawn
Ageo, Saitama, Japan, 3620075
Shiga University of Medical Science Hospital, Not yet recruiting
Otsu, Shiga, Japan, 5202192
Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic Recruiting
Susono, Shizuoka, Japan, 4101102
Fukuoka Wajiro Hospital Recruiting
Fukuoka, Japan, 8110213
Fukushima Medical University Hospital, Recruiting
Fukushima, Japan, 9601295
Ideta eye hospital, Recruiting
Kumamoto, Japan, 8600027
Nagasaki University Hospital, Recruiting
Nagasaki, Japan, 8528501
Kitano Hospital Not yet recruiting
Osaka, Japan, 5308480
Japanese Red Cross Saitama Hospital Recruiting
Saitama, Japan, 3308553
Latvia
Signe Ozolina's Private Practice in Ophthlamology, Recruiting
Jelgava, Latvia, LV-3001
P.Stradins Clinical University Hospital, Recruiting
Riga, Latvia, LV-1002
Riga East University Hospital, Clinical Centre Bikernieki, Recruiting
Riga, Latvia, LV-1006
Sponsors and Collaborators
Mylan Inc.
Momenta Pharmaceuticals, Inc.

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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: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases