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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-90
SponsorSaglik Bilimleri Universitesi

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Aflibercept biosimilar (MY-1701P)

    Drug

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

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: patients treated with Yesafili1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

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