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Could a biosimilar eye injection offer a new way to treat diabetic macular edema?

NCT ID NCT04674800

Disease control Sponsor: Mylan Pharmaceuticals Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing MYL-1701P, a proposed biosimilar to the existing eye medication Eylea, in people with diabetic macular edema who have already completed an earlier study with the same drug. The goal is to see if continued treatment with MYL-1701P is safe and effective over a longer period. Participants will receive three injections of the drug, given eight weeks apart, and will be monitored for side effects and changes in vision and retinal thickness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MYL-1701P, a proposed biosimilar to Eylea (aflibercept), given as eye injections
What this could lead to
If successful, this could support MYL-1701P as a safe and effective alternative to Eylea, potentially offering a more affordable treatment option for diabetic macular edema.
What could go wrong
This is an extension study with a small number of participants, so results may not be conclusive. As with any eye injection, there are risks of eye infection, inflammation, or increased eye pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

52 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Mylan Investigative Site

    Visakhapatnam, Andhra Pradesh, 530 040, India

  • Mylan Investigative Site

    Ahmedabad, Gujarat, 380015, India

  • Mylan Investigative Site

    Bangalore, Karnataka, 560094, India

  • Mylan Investigative Site

    Bengaluru, Karnataka, 560037, India

  • Mylan Investigative Site

    Mumbai, Maharashtra, 400050, India

  • Mylan Investigative Site

    Chandigarh, Punjab, 160012, India

  • Mylan Investigative Site

    Noida, Uttar Pradesh, 201301, India

  • Mylan Investigative site

    Hyderabad, Andhra Pradesh, 500034, India

  • Mylan Investigative site

    Ahmedabad, Gujarat, 380016, India

  • Mylan Investigative site

    Bangalore, Karnataka, 560 010, India

  • Mylan Investigative site

    New Delhi, New Delhi, 110029, India

  • Mylan Investigative site

    Bhubaneswar, Odisha, 751024, India

  • Mylan Investigative site

    Jaipur, Rajasthan, 302015, India

  • Mylan Investigative site

    Madurai, Tamil Nadu, 625 020, India

  • Mylan Investigative site

    Tirunelveli, Tamil Nadu, 627002, India

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