Age Related Macular DegenerationNCT07235527
Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration
An observational study of Age Related Macular Degeneration and Exudative Age-Related Macular Degeneration, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Age Related Macular Degeneration, Exudative Age-Related Macular Degeneration, Anti Vascular Endothelial Growth Factor
- What is being tested?
- Aflibercept biosimilar (MY-1701P)
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, şişli, 34384
About this study
Official title: Real-World Outcomes of Aflibercept Biosimilar MY-1701P Treatment in Exudative Age-Related Macular Degeneration
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
- Being tested
- Aflibercept biosimilar (MY-1701P)
- Keywords
- age related macular degeneration, anti vascular endothelial growth factor, anti-VEGF, aflibercept, macular neovascularization, aflibercept biosimilar
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept biosimilar (MY-1701P)Drug
Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| patients treated with Yesafili | aflibercept biosimilar used Receives: Drug: Aflibercept biosimilar (MY-1701P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025
- Primary completion20 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan KALPAKOĞLU, MD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235527
- Sponsor's protocol ID
- skalpakoglu
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcomes of Aflibercept Biosimilar MY-1701P Treatment in Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07235527
- Acronym / sponsor ID
- skalpakoglu
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with Yesafili | – | Drug: Aflibercept biosimilar (MY-1701P)aflibercept biosimilar used |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept biosimilar (MY-1701P)Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care. | Drug | patients treated with Yesafili |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection
Time frame: 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.
1 secondary outcome
Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment
Time frame: Baseline to Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Exudative Age-Related Macular Degeneration, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.