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

July 8, 2026 updated by: Mylan Pharmaceuticals Inc

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.

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 (NCT03610646) study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (NCT03610646) 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 (NCT03610646) 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 Best Corrected Visual Acuity (BCVA), Spectral domain- Optical Coherence Tomography (SD-OCT), complete ophthalmological examinations during the study.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Mylan Investigative Site
      • Visakhapatnam, Andhra Pradesh, India, 530 040
        • Mylan Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Mylan Investigative Site
      • Ahmedabad, Gujarat, India, 380016
        • Mylan Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 010
        • Mylan Investigative Site
      • Bangalore, Karnataka, India, 560094
        • Mylan Investigative Site
      • Bengaluru, Karnataka, India, 560037
        • Mylan Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400050
        • Mylan Investigative Site
    • New Delhi
      • New Delhi, New Delhi, India, 110029
        • Mylan Investigative Site
    • Odisha
      • Bhubaneswar, Odisha, India, 751024
        • Mylan Investigative Site
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Mylan Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302015
        • Mylan Investigative Site
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 020
        • Mylan Investigative Site
      • Tirunelveli, Tamil Nadu, India, 627002
        • Mylan Investigative Site
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201301
        • Mylan Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single, test arm
Open label, single arm study
Biological: MYL-1701P, a proposed biosimilar to Eylea
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs).
Time Frame: Week 20
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA at Week 8
Time Frame: Week 8
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Week 8
Change From Baseline in CRT at Week 8
Time Frame: Weeks 8
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Weeks 8
Change From Baseline in BCVA at Week 16
Time Frame: Week 16
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Week 16
Change From Baseline in BCVA at Week 20
Time Frame: Week 20
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Week 20
Change From Baseline in CRT at Week 16
Time Frame: Week 16
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Week 16
Change From Baseline in CRT at Week 20
Time Frame: Week 20
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Pharmaceuticals Inc

Collaborators

Momenta Pharmaceuticals, Inc.

Investigators

  • Study Director: Prasanna Ganapathi, MD, Mylan Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2020

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFIL-IJZ-3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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