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



Status:Recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:August 23, 2018
End Date:December 21, 2020
Contact:Prasanna C Ganapathi, MD
Email:PrasannaC.Ganapathi@mylan.in
Phone:+91-80 667 28859

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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

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.

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.

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.
We found this trial at
25
sites
Abilene, Texas 79606
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Augusta, Georgia 30909
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Augusta, GA
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Campbell, California 95008
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Chevy Chase, Maryland 20815
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Edison, New Jersey 08820
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Houston, Texas 77030
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Ladson, South Carolina 29456
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Las Vegas, Nevada 89128
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Las Vegas, NV
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Lynbrook, New York 11563
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Minneapolis, Minnesota 55404
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Morgantown, West Virginia 26506
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Nashville, Tennessee 37203
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Omaha, Nebraska 68114
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Paducah, Kentucky 42001
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Phoenix, Arizona 85020
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Praha 10, Vinohrady 10034
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Praha 10,
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Richmond, Virginia 23235
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Sacramento, California 95819
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Saint Petersburg, Florida 33711
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Santa Ana, California 92705
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Shawnee Mission, Kansas 66204
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Towson, Maryland 21204
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Warrenton, Virginia 20186
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Waterford, Connecticut 06385
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Winter Haven, Florida 33880
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Winter Haven, FL
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