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COMPLETED
NCT04674800
PHASE3

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

Sponsor: Mylan Pharmaceuticals Inc

View on ClinicalTrials.gov

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 (NCT03610646) study.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2020-11-23

Completion Date

2022-04-20

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

MYL-1701P, a proposed biosimilar to Eylea

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

Locations (15)

Mylan Investigative site

Hyderabad, Andhra Pradesh, India

Mylan Investigative Site

Visakhapatnam, Andhra Pradesh, India

Mylan Investigative Site

Ahmedabad, Gujarat, India

Mylan Investigative site

Ahmedabad, Gujarat, India

Mylan Investigative site

Bangalore, Karnataka, India

Mylan Investigative Site

Bangalore, Karnataka, India

Mylan Investigative Site

Bengaluru, Karnataka, India

Mylan Investigative Site

Mumbai, Maharashtra, India

Mylan Investigative site

New Delhi, New Delhi, India

Mylan Investigative site

Bhubaneswar, Odisha, India

Mylan Investigative Site

Chandigarh, Punjab, India

Mylan Investigative site

Jaipur, Rajasthan, India

Mylan Investigative site

Madurai, Tamil Nadu, India

Mylan Investigative site

Tirunelveli, Tamil Nadu, India

Mylan Investigative Site

Noida, Uttar Pradesh, India