Recruiting NCT07235527
Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aflibercept biosimilar (MY-1701P).
- Who it may be relevant to
- Registry conditions: Age Related Macular Degeneration, Exudative Age-Related Macular Degeneration, Anti Vascular Endothelial Growth Factor. Basic parameters: 45 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-World Outcomes of Aflibercept Biosimilar MY-1701P Treatment in Exudative Age-Related Macular Degeneration
Overview
In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.
Interventions
- Drug Aflibercept biosimilar (MY-1701P)
Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.
Primary outcome measures
- Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection [Time frame: Baseline to Month 6]
Secondary outcome measures (1)
- Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment [Time frame: Baseline to Month 6]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Prof. Dr. Cemil Taşcıoğlu City Hospital — Istanbul
Identifiers
NCT: NCT07235527 · skalpakoglu