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

NCT ID: NCT07235527

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-08-20

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients treated with Yesafili

aflibercept biosimilar used

Aflibercept biosimilar (MY-1701P)

Intervention Type DRUG

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

Interventions

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Aflibercept biosimilar (MY-1701P)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Sinan KALPAKOĞLU, MD

Ophthalmology Consultant, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, şişli, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sinan Kalpakoğlu, M.D.

Role: CONTACT

+905380518244

Facility Contacts

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Sinan Kalpakoğlu, m.d.

Role: primary

+905380518244

Other Identifiers

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skalpakoglu

Identifier Type: -

Identifier Source: org_study_id

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