Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
850
Countries
1
Sites
3
Neovascular age-related macular degeneration (NVAMD)
The primary objective is to demonstrate that EYE201/MK-8748 is non inferior to aflibercept with respect to mean change in BCVA (ETDRS letters) from baseline to Year 1
Key facts
- Sponsor
- Eyebiotech Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2026-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC · Eyebiotech Ltd.
External identifiers
- EU CT number
- 2025-524575-22-00
- WHO UTN
- U1111-1331-1650
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacokinetic, Safety, Efficacy, Therapy
The primary objective is to demonstrate that EYE201/MK-8748 is non inferior to aflibercept with respect to mean change in BCVA (ETDRS letters) from baseline to Year 1
Conditions and MedDRA coding
Neovascular age-related macular degeneration (NVAMD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10064930 | Age-related macular degeneration | 100000004853 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye)
- The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment
- Has a decrease in vision in the study eye that has been determined by the Investigator to be primarily the result of NVAMD
Exclusion criteria 7
- Has uncontrolled blood pressure at screening
- History of any prior macular laser photocoagulation in the study eye
- History of uveitis in either eye
- History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study
- Has uncontrolled glaucoma in the study eye
- Active retinal disease other than the condition under investigation in the study eye
- Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD13329993 · Product
- Active substance
- MK-8748
- Pharmaceutical form
- SOLUTION FOR INTRAVITREAL INJECTION
- Route of administration
- OTHER USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- EYEBIOTECH LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SCP134511961 · ATC
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 92 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — AFLIBERCEPT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eyebiotech Limited
- Sponsor organisation
- Eyebiotech Limited
- Address
- 120 Moorgate
- City
- London
- Postcode
- EC2M 6UR
- Country
- United Kingdom
Scientific contact point
- Organisation
- Eyebiotech Limited
- Contact name
- Loni Da Silva
Public contact point
- Organisation
- Eyebiotech Limited
- Contact name
- Loni Da Silva
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Almac Pharma Services Limited ORG-100033269
|
Craigavon, United Kingdom | Interactive response technologies (IRT) |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| International Drug Development Institute ORG-100028563
|
Ottignies-Louvain-La-Neuve, Belgium | Code 10 |
| Immunologix ORL-000017449
|
Tampa, United States | Laboratory analysis |
| TFS Trial Form Support AB ORG-100008755
|
Lund, Sweden | On site monitoring, Code 2, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Latvia | Authorised, recruitment pending | 20 | 3 |
| Rest of world
Israel, Australia, United States, United Kingdom, Argentina, Switzerland
|
— | 830 | — |
Investigational sites
Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki"
Ophtalmology, Lielvardes Street 68, 1006, Riga
Northern Kurzeme Regional Hospital
Ophthalmology, Inzenieru street 60, 3601, Ventspils
Pauls Stradins Clinical University Hospital
Ophtalmology, Pilsonu Iela 13, 1002, Riga
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-524575-22_IN-RFI010_for pub | 1.2 EU |
| Protocol (for publication) | D4_Copyright statement_EN_IN_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LVA_EN_IN_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LVA_LV_IN-RFI003_for pub | v1-0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LVA_RU_IN-RFI003_for pub | v1-0R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_LVA_LV_IN-RFI003_for pub | v1-0R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_LVA_RU_IN-RFI003_for pub | v1-0R |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_AFLIBERCEPT_IN_for pub | BAYER PLC |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524575-22_DE_DE_IN-RFI001_for pub | 1-0R |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524575-22_ESP_ES_IN-RFI001_for pub | 1-0R |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524575-22_IN-RFI001_for pub | 1-0R |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524575-22_POL_PL_IN-RFI001_for pub | 1-0R |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-05 | Acceptable 2026-06-01
|
2026-06-03 |