NCT04674800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

November 30, 2020

Last Update Submit

August 25, 2022

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular EdemaBCVAETDRS Letters

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment emergent adverse events (TEAEs).

    Number of participants with TEAEs

    Week 20

Secondary Outcomes (2)

  • Change from baseline in BCVA

    Weeks 8, 16 and 20

  • Change from baseline in CRT

    Weeks 8, 16 and 20

Study Arms (1)

Single, test arm

EXPERIMENTAL

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

Biological: MYL-1701P, a proposed biosimilar to Eylea

Interventions

MYL-1701P, a proposed biosimilar to EyleaBIOLOGICAL

Open label and single arm

Single, test arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Mylan Investigative site

Hyderabad, Andhra Pradesh, 500034, India

Location

Mylan Investigative Site

Visakhapatnam, Andhra Pradesh, 530 040, India

Location

Mylan Investigative Site

Ahmedabad, Gujarat, 380015, India

Location

Mylan Investigative site

Ahmedabad, Gujarat, 380016, India

Location

Mylan Investigative site

Bangalore, Karnataka, 560 010, India

Location

Mylan Investigative Site

Bangalore, Karnataka, 560094, India

Location

Mylan Investigative Site

Bengaluru, Karnataka, 560037, India

Location

Mylan Investigative Site

Mumbai, Maharashtra, 400050, India

Location

Mylan Investigative site

Bhubaneswar, Odisha, 751024, India

Location

Mylan Investigative Site

Chandigarh, Punjab, 160012, India

Location

Mylan Investigative site

Jaipur, Rajasthan, 302015, India

Location

Mylan Investigative site

Madurai, Tamil Nadu, 625 020, India

Location

Mylan Investigative site

Tirunelveli, Tamil Nadu, 627002, India

Location

Mylan Investigative Site

Noida, Uttar Pradesh, 201301, India

Location

Mylan Investigative site

New Delhi, 110029, India

Location

Study Officials

  • Prasanna Ganapathi, MD

    Mylan Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 19, 2020

Study Start

November 23, 2020

Primary Completion

April 20, 2022

Study Completion

April 20, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(15)