Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration

December 5, 2025 updated by: Sinan KALPAKOĞLU, MD, Saglik Bilimleri Universitesi

Real-World Outcomes of Aflibercept Biosimilar MY-1701P Treatment in Exudative Age-Related Macular Degeneration

In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey (Türkiye)
    • şişli
      • Istanbul, şişli, Turkey (Türkiye), 34384
        • Recruiting
        • Prof. Dr. Cemil Taşcıoğlu City Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 45 to 90 years diagnosed with active neovascular (exudative) age-related macular degeneration (nAMD), who are receiving routine ophthalmologic follow-up at a tertiary referral center and have been clinically indicated for intravitreal aflibercept biosimilar (MY-1701P) injection. Participants will be selected based on evidence of disease activity on ophthalmologic examination and optical coherence tomography (OCT) imaging.

Description

Inclusion Criteria:

  • Patients aged between 45 and 90 years with active neovascular age-related macular degeneration (nAMD)
  • who show signs of disease activity on routine ophthalmologic examination and optical coherence tomography (OCT)
  • for whom intravitreal injection has already been clinically indicated

Exclusion Criteria:

  • Patients younger than 45 years or older than 90 years
  • History of stroke, cerebrovascular event, myocardial infarction, or coronary stent placement within the last six months
  • Presence of uveitis
  • Media opacity preventing adequate retinal imaging (e.g., corneal opacity, mature cataract)
  • Coexistence of other retinal vascular diseases (e.g., branch retinal vein occlusion, diabetic macular edema)
  • Presence of hereditary retinal dystrophies
  • Presence of optic atrophy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated with Yesafili
aflibercept biosimilar used
Drug: Aflibercept biosimilar (MY-1701P)
Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection
Time Frame: Baseline to Month 6
Evaluation of anatomical and functional outcomes following intravitreal MY-1701P (aflibercept biosimilar) treatment, including presence or resolution of intraretinal and subretinal fluid, changes in central macular thickness, and improvement in best-corrected visual acuity (BCVA) measured by standardized ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen methods.
Baseline to Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment
Time Frame: Baseline to Month 6
Assessment of the influence of MY-1701P treatment on pigment epithelial detachment (PED) height and area, macular neovascularization size, and changes in treatment intervals over the follow-up period, based on optical coherence tomography (OCT) and fluorescein angiography findings.
Baseline to Month 6

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

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 20, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 20, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • skalpakoglu

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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