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

NCT07235527 | Recruiting FDA Drug

• 1 other identifier: skalpakoglu
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.

Conditions

Age Related Macular Degeneration; Exudative Age-Related Macular Degeneration; Anti Vascular Endothelial Growth Factor

Keywords

age related macular degeneration; anti vascular endothelial growth factor; anti-VEGF; aflibercept; macular neovascularization; aflibercept biosimilar

Outcome Measures

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.

  Baseline to Month 6

Secondary Outcomes (1)

• Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment

  Baseline to Month 6

Study Arms (1)

patients treated with Yesafili

aflibercept biosimilar used

Drug: Aflibercept biosimilar (MY-1701P)

Interventions

Aflibercept biosimilar (MY-1701P) DRUG

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

patients treated with Yesafili

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, şişli, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Sinan Kalpakoğlu, M.D.

CONTACT

+905380518244; sinankalpakoglu17@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Consultant, Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

TU (1)