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

Sponsor

Mylan Pharmaceuticals Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT03610646

Collaborator

Momenta Pharmaceuticals, Inc. (Industry)

355

Enrollment

Locations

Arms

36.6

Actual Duration (Months)

4.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

355 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 studyParticipants 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 :

Aug 23, 2018

Actual Primary Completion Date :

Nov 10, 2020

Actual Study Completion Date :

Sep 10, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The mean change from baseline in BCVA at week 8 [From baseline to week 8]
The mean change from baseline in BCVA as assessed by ETDRS letters at week 8

Secondary Outcome Measures

The mean change from baseline in CRT [From baseline to week 52]
The mean change from baseline in CRT as determined by SD-OCT over time
The mean change in BCVA [From baseline to week 52]
The mean change in BCVA over time
Proportion of subjects who gained ≥15 letters from Baseline in BCVA [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 [From baseline to week 52]
Number of administrations of study drug required
Incidence of treatment emergent adverse events (Safety and tolerability) [From baseline to week 52]
Incidence of treatment emergent adverse events
Proportion of subjects testing positive for Anti-Drug Antibodies (ADA) (Immunogenicity) [From baseline to week 52]
Proportion of subjects testing positive for Anti-Drug Antibodies
Concentration of aflibercept in blood (Pharmacokinetics) [From baseline to week 52]
Concentration of aflibercept in blood (Pharmacokinetics)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects age ≥ 18 years.
Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
Subject is able to understand and voluntarily provide written informed consent to participate in the study.
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.
If female, subject must be:
Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
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.
Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
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.
Subject is willing to comply with the study duration, study visits and study related procedures.

Exclusion Criteria:

Subjects with known hypersensitivity to aflibercept or any of the excipients
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
Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
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
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mylan Investigator Site	Phoenix	Arizona	United States	85014
2	Mylan Investigator Site	Phoenix	Arizona	United States	85020
3	Mylan Investigator Site	Sacramento	California	United States	95841
4	Mylan Investigator Site	Saint Petersburg	Florida	United States	33711
5	Mylan Investigator Site	Winter Haven	Florida	United States	33880
6	Mylan Investigator Site	Augusta	Georgia	United States	30909
7	Mylan Investigator Site	Shawnee Mission	Kansas	United States	66204
8	Mylan Investigator Site	Paducah	Kentucky	United States	42001
9	Mylan Investigator Site	Chevy Chase	Maryland	United States	20815
10	Mylan Investigator Site	Ladson	South Carolina	United States	29456
11	Mylan Investigator Site	Nashville	Tennessee	United States	37203
12	Mylan Investigator Site	Abilene	Texas	United States	79606
13	Mylan Investigator Site	Morgantown	West Virginia	United States	26506
14	Mylan Investigator Site	Praha 10	Vinohrady	Czechia	10034
15	Mylan Investigator Site	Hradec Králové		Czechia	50005
16	Mylan Investigator Site	Olomouc		Czechia	77900
17	Mylan Investigator Site	Pardubice		Czechia	53002
18	Mylan Investigator Site	Praha 2		Czechia	12808
19	Mylan Investigator Site	Praha 5		Czechia	15000
20	Mylan Investigator Site	Zlín		Czechia	76275
21	Mylan Investigator Site	Göttingen	Lower Saxony	Germany	37075
22	Mylan Investigator Site	Mainz	Rheinland-Pflaz	Germany	55131
23	Mylan Investigator Site	Marburg		Germany	35043
24	Mylan Investigator Site	Budapest		Hungary	1076
25	Mylan Investigator Site	Budapest		Hungary	1106
26	Mylan Investigator Site	Debrecen		Hungary	4032
27	Mylan Investigator Site	Nyíregyháza		Hungary	4400
28	Mylan Investigator Site	Pecs		Hungary	7621
29	Mylan Investigator Site	Szeged		Hungary	6720
30	Mylan Investigator Site	Zalaegerszeg		Hungary	8900
31	Mylan Investigator Site	Visakhapatnam	Andhra Pradesh	India	530040
32	Mylan Investigator Site	New Delhi	Delhi	India	110029
33	Mylan Investigator Site	Ahmedabad	Gujarat	India	380015
34	Mylan Investigator Site	Ahmedabad	Gujarat	India	380016
35	Mylan Investigator Site	Bangalore	Karnataka	India	560010
36	Mylan Investigator site	Bangalore	Karnataka	India	560037
37	Mylan Investigator Site	Bangalore	Karnataka	India	560094
38	Mylan Investigator Site	Mumbai	Maharashtra	India	400050
39	Mylan Investigator Site	Bhubaneswar	Orissa	India	751024
40	Mylan Investigator Site	Chandigarh	Punjab	India	160012
41	Mylan Investigator Site	Jaipur	Rajasthan	India	302015
42	Mylan Investigator Site	Madurai	Tamilnadu	India	625020
43	Mylan Investigator Site	Tirunelveli	Tamilnadu	India	627002
44	Mylan Investigator Site	Hyderabad	Telangana	India	500034
45	Mylan Investigator Site	Noida	Uttar Pradesh	India	201301
46	Mylan Investigator Site	Nagoya	Aichi	Japan	4578510
47	Mylan Investigator Site	Koriyama	Fukushima	Japan	9638052
48	Mylan Investigator Site	Sapporo	Hokkaido	Japan	0608604
49	Mylan Investigator Site	Mito	Ibaraki	Japan	3100845
50	Mylan Investigator Site	Yamato	Kanagawa	Japan	2420001
51	Mylan Investigator Site	Susono	Shizuoka	Japan	4101102
52	Mylan Investigator Site	Kōfu	Yamanashi	Japan	4008506
53	Mylan Investigator Site	Fukuoka		Japan	8110213
54	Mylan Investigator Site	Fukushima		Japan	9601295
55	Mylan Investigator Site	Kagoshima		Japan	8920824
56	Mylan Investigator Site	Kumamoto		Japan	8600027
57	Mylan Investigator Site	Nagasaki		Japan	8528501
58	National Hospital Organization Osaka National Hospital	Osaka		Japan	5400006
59	Mylan Investigator Site	Saitama		Japan	3308553
60	Mylan Investigator Site	Jelgava		Latvia	LV-3001
61	Mylan Investigator Site	Riga		Latvia	LV-1002
62	Mylan Investigator Site	Riga		Latvia	LV-1006
63	Mylan Investigator Site	Łódź	Lodzkie	Poland	91134
64	Mylan Investigator Site	Katowice	Slaskie	Poland	40594
65	Mylan Investigator Site	Tarnów	Tarnow	Poland	33100
66	Mylan Investigator Site	Olsztyn	Warminsko-Mazurskie	Poland	10424
67	Mylan Investigator Site	Rzeszów		Poland	35017
68	Mylan Investigator Site	Wałbrzych		Poland	58309
69	Mylan Investigator Site	Kazan	Tatarstan Resp.	Russian Federation	420012
70	Mylan Investigator Site	Moscow		Russian Federation	119021
71	Mylan Investigator Site	Novosibirsk		Russian Federation	630096
72	Mylan Investigator Site	Omsk		Russian Federation	644042
73	Mylan Investigator Site	Saint Petersburg		Russian Federation	197022

Sponsors and Collaborators

Mylan Pharmaceuticals Inc
Momenta Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mylan Pharmaceuticals Inc

ClinicalTrials.gov Identifier:

NCT03610646

Other Study ID Numbers:

MYL-1701P-3001

First Posted:

Aug 1, 2018

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mylan Pharmaceuticals Inc

Diabetic Macular Edema,

BCVA,

ETDRS Letters.

Additional relevant MeSH terms:

Macular Edema

Edema

Study Results

No Results Posted as of Mar 31, 2022