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Extension Study of MYL-1701P-3001 for Safety and Efficacy

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
MYL-1701P, a proposed biosimilar to Eylea
Sponsored by
Mylan Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, BCVA, ETDRS Letters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject participated in the MYL-1701P-3001 study
  2. Subject requires treatment with intravitreal anti-VEGF therapy
  3. Subject is able to understand and voluntarily provide written informed consent to participate in the study.
  4. If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
  5. Subject is willing to comply with the study duration, study visits and study related procedures.

  6. 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
    • Of non-childbearing potential
  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

Exclusion Criteria:

  1. Subjects with known hypersensitivity to aflibercept or any of the excipients

  2. Subjects will be excluded if any of the following conditions are met in the study eye:

    • Subjects with active ocular inflammation.
    • Subjects with uncontrolled glaucoma
    • Surgery for glaucoma in the past or likely to be needed in the future.
  3. Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
  4. Subjects who plan to participate in another clinical study while enrolled in this study.
  5. Subjects receiving treatment for a serious systemic infection.
  6. Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg.
  7. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment.
  8. Subjects with renal failure requiring dialysis or renal transplant.
  9. Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.

Sites / Locations

  • Mylan Investigative site
  • Mylan Investigative Site
  • Mylan Investigative Site
  • Mylan Investigative site
  • Mylan Investigative site
  • Mylan Investigative Site
  • Mylan Investigative Site
  • Mylan Investigative Site
  • Mylan Investigative site
  • Mylan Investigative Site
  • Mylan Investigative site
  • Mylan Investigative site
  • Mylan Investigative site
  • Mylan Investigative Site
  • Mylan Investigative site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single, test arm

Arm Description

MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval

Outcomes

Primary Outcome Measures

Incidence of Treatment emergent adverse events (TEAEs).
Number of participants with TEAEs

Secondary Outcome Measures

Change from baseline in BCVA
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Change from baseline in CRT
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)

Full Information

First Posted
November 30, 2020
Last Updated
August 25, 2022
Sponsor
Mylan Pharmaceuticals Inc
Collaborators
Momenta Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04674800
Brief Title
Extension Study of MYL-1701P-3001 for Safety and Efficacy
Official Title
A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Pharmaceuticals Inc
Collaborators
Momenta Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.
Detailed Description
Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema. EYLEA® (aflibercept) injection, an anti-Vascular Endothelial Growth Factor (VEGF) agent, has been approved by the FDA and EMA for the treatment of Diabetic Macular Edema (DME). Mylan Inc. and Momenta Pharmaceuticals, Inc. are developing MYL-1701P, a proposed biosimilar to Eylea. MYL-1701P-3001 study was designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of MYL-1701P in the treatment of subjects with Diabetic Macular Edema (DME). Eligible subjects from MYL-1701P-3001 study will be enrolled in the AFIL-IJZ-3002 study. All enrolled subjects will receive three doses of MYL-1701P every eight weeks. Subjects will attend the clinic visits for safety and efficacy assessments including BCVA, SD-OCT, complete ophthalmological examinations during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, BCVA, ETDRS Letters

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single, test arm
Arm Type
Experimental
Arm Description
MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
Intervention Type
Biological
Intervention Name(s)
MYL-1701P, a proposed biosimilar to Eylea
Intervention Description
Open label and single arm
Primary Outcome Measure Information:
Title
Incidence of Treatment emergent adverse events (TEAEs).
Description
Number of participants with TEAEs
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Change from baseline in BCVA
Description
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Time Frame
Weeks 8, 16 and 20
Title
Change from baseline in CRT
Description
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Time Frame
Weeks 8, 16 and 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject participated in the MYL-1701P-3001 study Subject requires treatment with intravitreal anti-VEGF therapy Subject is able to understand and voluntarily provide written informed consent to participate in the study. If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy. Subject is willing to comply with the study duration, study visits and study related procedures. 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 Of non-childbearing potential If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control Exclusion Criteria: Subjects with known hypersensitivity to aflibercept or any of the excipients Subjects will be excluded if any of the following conditions are met in the study eye: Subjects with active ocular inflammation. Subjects with uncontrolled glaucoma Surgery for glaucoma in the past or likely to be needed in the future. Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye. Subjects who plan to participate in another clinical study while enrolled in this study. Subjects receiving treatment for a serious systemic infection. Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment. Subjects with renal failure requiring dialysis or renal transplant. Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasanna Ganapathi, MD
Organizational Affiliation
Mylan Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mylan Investigative site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Mylan Investigative Site
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530 040
Country
India
Facility Name
Mylan Investigative Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Mylan Investigative site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Mylan Investigative site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 010
Country
India
Facility Name
Mylan Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560094
Country
India
Facility Name
Mylan Investigative Site
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560037
Country
India
Facility Name
Mylan Investigative Site
City
Mumbai
State/Province
Maharastra
ZIP/Postal Code
400050
Country
India
Facility Name
Mylan Investigative site
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751024
Country
India
Facility Name
Mylan Investigative Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Mylan Investigative site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302015
Country
India
Facility Name
Mylan Investigative site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
Facility Name
Mylan Investigative site
City
Tirunelveli
State/Province
Tamilnadu
ZIP/Postal Code
627002
Country
India
Facility Name
Mylan Investigative Site
City
Noida
State/Province
Uttar Pradesh
ZIP/Postal Code
201301
Country
India
Facility Name
Mylan Investigative site
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Extension Study of MYL-1701P-3001 for Safety and Efficacy

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