About this trial
In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients aged 45 to 90 years diagnosed with active neovascular (exudative) age-related macular degeneration (nAMD), who are receiving routine ophthalmologic follow-up at a tertiary referral center and have been clinically indicated for intravitreal aflibercept biosimilar (MY-1701P) injection. Participants will be selected based on evidence of disease activity on ophthalmologic examination and optical coherence tomography (OCT) imaging.
Trial design
Cohort
Prospective
Treatments tested in this trial
Aflibercept biosimilar (MY-1701P)
DrugPatients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.
Treatment groups
Trial 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.
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.
Sponsors and contacts
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