Age Related Macular Degeneration, Anti Vascular Endothelial Growth Factor, Exudative Age-Related Macular Degeneration
Conditions
Keywords
age related macular degeneration, anti vascular endothelial growth factor, anti-VEGF, aflibercept, macular neovascularization, aflibercept biosimilar
Brief summary
In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.
Interventions
DRUGAflibercept biosimilar (MY-1701P)
Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.
Sponsors
Saglik Bilimleri Universitesi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed