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NCT Number: NCT07235527

Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of 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.

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Key information

Conditions

Age Related Macular Degeneration Anti Vascular Endothelial Growth Factor Exudative Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, şişli, 34384, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sinan Kalpakoğlu, m.d.

CONTACT

[email protected]

+905380518244

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept biosimilar (MY-1701P)

Drug

Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sinan Kalpakoğlu, M.D.

CONTACT

[email protected]

+905380518244

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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