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

Saglik Bilimleri Universitesi54 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Interventions

Aflibercept biosimilar (MY-1701P)DRUG

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, şişli, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection

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.

Time frame: Baseline to Month 6

Secondary Outcomes

Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment

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.

Time frame: Baseline to Month 6

Central Contacts

Sinan Kalpakoğlu, M.D.

CONTACT

+905380518244 sinankalpakoglu17@gmail.com

Data from ClinicalTrials.gov

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