Real-world outcomes of Yesafili (aflibercept biosimilar) for wet age-related macular degeneration
Real-World Outcomes of Aflibercept Biosimilar MY-1701P Treatment in Exudative Age-Related Macular Degeneration
This project will try using the aflibercept biosimilar Yesafili (MY-1701P) in people aged 45–90 with active wet age-related macular degeneration and record routine exam and OCT results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 54 (estimated) |
| Ages | 45 Years to 90 Years |
| Sex | All |
| Sponsor | Saglik Bilimleri Universitesi Academic / other |
| Locations | 1 site (Istanbul, şişli) |
| Trial ID | NCT07235527 on ClinicalTrials.gov |
What this trial studies
This is an observational, single-center study in which patients who would receive aflibercept (Eylea) in routine care are treated with the biosimilar Yesafili (MY-1701P) and followed with standard ophthalmic exams and optical coherence tomography. Clinical data captured will include visual acuity, OCT measures of retinal fluid and macular anatomy, injection frequency, and any adverse events. No experimental procedures beyond standard intravitreal injections are planned; treatment decisions follow routine clinical indications. The goal is to describe real-life effectiveness and safety of the biosimilar in a typical clinical practice setting at Prof. Dr. Cemil Taşcıoğlu City Hospital in Istanbul.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45–90 with active neovascular (wet) AMD who show disease activity on exam/OCT and for whom an intravitreal aflibercept injection is clinically indicated.
Not a fit: Patients outside the 45–90 age range or with recent major cardiovascular events, uveitis, media opacity blocking retinal imaging, other retinal vascular diseases, hereditary retinal dystrophies, or optic atrophy are excluded and unlikely to benefit from this observational biosimilar switch.
Why it matters
Potential benefit: If successful, this could show comparable vision outcomes and safety to the branded drug while potentially lowering treatment costs and improving access.
How similar studies have performed: Other aflibercept biosimilars and biosimilar switches have shown comparable anatomical and visual outcomes in several small studies and real-world reports, but larger long-term data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, şişli
- Prof. Dr. Cemil Taşcıoğlu City Hospital — Istanbul, şişli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sinan Kalpakoğlu, M.D.
- Email: sinankalpakoglu17@gmail.com
- Phone: +905380518244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.