Clinical trial • Phase III • Ophthalmology
vorolanib for Wet age-related macular degeneration
Phase III trial of vorolanib for Wet age-related macular degeneration.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Wet age-related macular degeneration
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 31-01-2025
- First CTIS Authorization Date
- 14-05-2025
Trial design
Randomised, eylea (aflibercept) 40 mg/ml solution for injection in pre-filled syringe; dose/schedule not specified in the ctis record.-controlled Phase III trial in Germany, Czechia, Hungary and others.
- Randomised
- Yes
- Comparator
- Eylea (aflibercept) 40 mg/mL solution for injection in pre-filled syringe; dose/schedule not specified in the CTIS record.
- Target Sample Size
- 257
- Trial Duration For Participant
- 672
Eligibility
Recruits 257 Vulnerable population selected (isVulnerablePopulationSelected: true). Participants must be able to understand and be willing to sign the informed consent and provide access to personal health information; inclusion age is ≥50 years. No procedures for assent of minors are provided (study enrols adults only)..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Participants must be able to understand and be willing to sign the informed consent and provide access to personal health information; inclusion age is ≥50 years. No procedures for assent of minors are provided (study enrols adults only).
Inclusion criteria
- {"criterion_text":"- Subjects will be considered eligible for participation in the study if inclusion criteria are satisfied: 1. Male or female subjects, ≥50 years of age."}
- {"criterion_text":"- 2. Able to understand, and willingness to sign, the informed consent and to provide access to personal health information."}
- {"criterion_text":"- 3. Willingness and ability to comply with all scheduled visits, restrictions, and assessments."}
- {"criterion_text":"- 4. For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study. For the full list of the inclusion criteria please refer to Protocol section 4.1."}
Exclusion criteria
- {"criterion_text":"- Subjects who meet any of the following exclusion criteria will be excluded from the study: 1. Ocular Exclusion Criteria for the Study Eye Only"}
- {"criterion_text":"- 2. Ocular Exclusion Criteria for Either Eye"}
- {"criterion_text":"- 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.","definition_or_measurement_approach":"Efficacy evaluated by comparison of changes in best corrected visual acuity (BCVA) for EYP-1901 2686 μg intravitreal insert versus aflibercept over 56 weeks (main objective: BCVA changes compared to aflibercept)."}
Secondary endpoints
- {"endpoint_text":"- The secondary endpoints of the study are to find out: 1. Total number of supplemental injections of aflibercept needed over the 56 weeks of treatment","definition_or_measurement_approach":"Count of supplemental aflibercept injections required during the 56-week treatment period."}
- {"endpoint_text":"- 2. Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from Week 12 through Week 56 of treatment","definition_or_measurement_approach":"Change in retinal thickness measured from Week 12 through Week 56 (measurement method not specified in record; likely OCT-based retinal thickness assessments)."}
- {"endpoint_text":"- 3. Number of injections a participant needs up to 96 weeks of treatment","definition_or_measurement_approach":"Count of injections required per participant up to 96 weeks."}
- {"endpoint_text":"- 4. Changes in the retina structure and function over the 96 weeks of treatment","definition_or_measurement_approach":"Assessment of retinal structure and function changes over 96 weeks (specific measures not specified in record)."}
Recruitment
- Registry Or Advocacy Recruitment
- True - Patient Advocacy Groups (PAG) (specific group names not specified in record)
- Digital Remote Recruitment
- True - social media advertising, website/landing pages, online clinical trial listing, email blasts to patients via advocacy/PAG, phone screener.
- Planned Sample Size
- 257
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent must be provided by the participant: 'Able to understand, and willingness to sign, the informed consent'. Consent materials (SIS/ICF and pregnancy-specific ICFs) are provided; versions available for multiple languages/countries (documents include English, Hungarian, Slovak, Czech, Polish and German language versions or country-specific ICFs). No assent process for minors is described (study enrols adults ≥50).
Methods
- Social media ads/packets targeting patients (documents: Social Media Ads, SK Social Media Packet) — country documents available for Germany, Czechia, Hungary, Poland, Slovakia.
- Site awareness posters placed in clinics (Site Awareness Poster documents).
- HCP (healthcare professional) study flyers to referring clinicians (HCP Study Flyer).
- Patient brochures and patient-facing materials (Patient Brochure, Patient-facing NEI VFQ-25 questionnaire).
- Advocacy / Patient Advocacy Group (PAG) email blasts to patients and PAG-to-patient communications (Advocacy PAG to Patient Email Blast, PAG FAQ sheets).
- Dr-to-Dr letters (physician-to-physician recruitment outreach).
- Phone screener to pre-screen interested participants (Phone Screener document).
- Study landing pages / website content and online clinical trial listing (Landing Page, Website Content, Clinical Trial Listing).
- Site-facing recruitment/pre-screening/local ad portal support (third party: Neonstone - 'site facing recruitment/pre-screening/local ad portal').
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 143
Germany
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 373
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Augenheilkunde
- Principal Investigator Name
- Hansjürgen Agostini
- Principal Investigator Email
- augenklinik.direktion@uniklinik-freiburg.de
- Contact Person Name
- Hansjürgen Agostini
- Contact Person Email
- augenklinik.direktion@uniklinik-freiburg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Augenheilkunde/Studienambulanz
- Principal Investigator Name
- Antonia Joussen
- Principal Investigator Email
- antonia.joussen@charite.de
- Contact Person Name
- Antonia Joussen
- Contact Person Email
- antonia.joussen@charite.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Department Name
- Augenklinik
- Principal Investigator Name
- Lars-Olof Hattenbach
- Principal Investigator Email
- hattenbach.studien@klilu.de
- Contact Person Name
- Lars-Olof Hattenbach
- Contact Person Email
- hattenbach.studien@klilu.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Augenheilkunde
- Principal Investigator Name
- Dirk Sandner
- Principal Investigator Email
- Dirk.Sandner@uniklinikum-dresden.de
- Contact Person Name
- Dirk Sandner
- Contact Person Email
- Dirk.Sandner@uniklinikum-dresden.de
- Site Name
- St. Elisabeth Krankenhaus GmbH
- Department Name
- Augenheilkunde
- Principal Investigator Name
- Hüsnü Berk
- Principal Investigator Email
- huesnue.berk@hohenlind.de
- Contact Person Name
- Hüsnü Berk
- Contact Person Email
- huesnue.berk@hohenlind.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-04-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 371
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Medical Private Care s.r.o.
- Principal Investigator Name
- Andrej Farkaš
- Principal Investigator Email
- andrej.farkas@nemocnicesokolov.cz
- Contact Person Name
- Andrej Farkaš
- Contact Person Email
- andrej.farkas@nemocnicesokolov.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Ophthalmology clinic
- Principal Investigator Name
- Miroslav Veith
- Principal Investigator Email
- miroslav.veith@fnkv.cz
- Contact Person Name
- Miroslav Veith
- Contact Person Email
- miroslav.veith@fnkv.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Eye Clinic
- Principal Investigator Name
- Bohdan Kousal
- Principal Investigator Email
- bohdan.kousal@vfn.cz
- Contact Person Name
- Bohdan Kousal
- Contact Person Email
- bohdan.kousal@vfn.cz
- Site Name
- Axon Clinical s.r.o.
- Principal Investigator Name
- Jan Ernest
- Principal Investigator Email
- jan.ernest@axon-clinical.com
- Contact Person Name
- Jan Ernest
- Contact Person Email
- jan.ernest@axon-clinical.com
- Site Name
- Visus spol. s r.o.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Jan Studnička
- Principal Investigator Email
- jan.studnicka@post.cz
- Contact Person Name
- Jan Studnička
- Contact Person Email
- jan.studnicka@post.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Eye Clinic
- Principal Investigator Name
- Jan Němčanský
- Principal Investigator Email
- jan.nemcansky@fno.cz
- Contact Person Name
- Jan Němčanský
- Contact Person Email
- jan.nemcansky@fno.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 23-04-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 372
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Budapest Retina Associates Kft.
- Department Name
- Ophtalmology
- Principal Investigator Name
- András Seres
- Principal Investigator Email
- seres@budapestretina.hu
- Contact Person Name
- András Seres
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
- Department Name
- Ophtalmology
- Principal Investigator Name
- Ágnes Kerényi
- Principal Investigator Email
- agneskerenyi@gmail.com
- Contact Person Name
- Ágnes Kerényi
- Contact Person Email
- agneskerenyi@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Ophtalmology
- Principal Investigator Name
- András Papp
- Principal Investigator Email
- papp.andras1@med.semmelweis-univ.hu
- Contact Person Name
- András Papp
- Contact Person Email
- papp.andras1@med.semmelweis-univ.hu
- Site Name
- University Of Szeged
- Department Name
- Ophtalmology
- Principal Investigator Name
- Edit Tóth-Molnár
- Principal Investigator Email
- toth-molnar.edit@med.u-szeged.hu
- Contact Person Name
- Edit Tóth-Molnár
- Contact Person Email
- toth-molnar.edit@med.u-szeged.hu
- Site Name
- University Of Pecs
- Department Name
- Ophtalmology
- Principal Investigator Name
- Adrienne Csutak
- Principal Investigator Email
- csutak.adrienne@pte.hu
- Contact Person Name
- Adrienne Csutak
- Contact Person Email
- csutak.adrienne@pte.hu
- Site Name
- University Of Debrecen
- Department Name
- Ophtalmology
- Principal Investigator Name
- Attila Vajas
- Principal Investigator Email
- vajasa@gmail.com
- Contact Person Name
- András Papp
- Contact Person Email
- vajasa@gmail.com
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Ophtalmology
- Principal Investigator Name
- Gábor Vogt
- Principal Investigator Email
- gabor.vogt@tosho.hu
- Contact Person Name
- Gábor Vogt
- Contact Person Email
- gabor.vogt@tosho.hu
- Site Name
- Nozologen Kft.
- Department Name
- Ophtalmology
- Principal Investigator Name
- Balázs Varsányi
- Principal Investigator Email
- varsanyi.balazs@ganglion.hu
- Contact Person Name
- Balázs Varsányi
- Contact Person Email
- varsanyi.balazs@ganglion.hu
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- Ophtalmology
- Principal Investigator Name
- Norbert Czumbel
- Principal Investigator Email
- czumbel@gmail.com
- Contact Person Name
- Norbert Czumbel
- Contact Person Email
- czumbel@gmail.com
- Site Name
- Zala Varmegyei Szent Rafael Korhaz
- Department Name
- Ophtalmology
- Principal Investigator Name
- Krisztina Fatalin
- Principal Investigator Email
- fatalinkrisztina@freemail.com
- Contact Person Name
- Krisztina Fatalin
- Contact Person Email
- fatalinkrisztina@freemail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 350
- Number Of Sites
- 7
- Number Of Participants
- 34
Sites
- Site Name
- Centrum Medyczne Uno-Med Sp. z o.o.
- Department Name
- Centrum Medyczne UNO-MED
- Principal Investigator Name
- Piotr Oleksy
- Principal Investigator Email
- piotroleksy@yahoo.pl
- Contact Person Name
- Piotr Oleksy
- Contact Person Email
- piotroleksy@yahoo.pl
- Site Name
- Warszawski Szpital Okulistyczny Sp. z o.o.
- Department Name
- Warszawski Szpital Okulistyczny
- Principal Investigator Name
- Agnieszka Nowosielska
- Principal Investigator Email
- klinika@wszo.pl
- Contact Person Name
- Agnieszka Nowosielska
- Contact Person Email
- klinika@wszo.pl
- Site Name
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
- Department Name
- Mikrochirurgii Oka -LENS Sp. z o.o.
- Principal Investigator Name
- Dominik Zalewski
- Principal Investigator Email
- kobak.lens@gmail.com
- Contact Person Name
- Dominik Zalewski
- Contact Person Email
- kobak.lens@gmail.com
- Site Name
- Mackiewicz Okulistyka Sp. z o.o.
- Department Name
- Gabinet Okulistyczny Jerzy Mackiewicz
- Principal Investigator Name
- Jerzy Mackiewicz
- Principal Investigator Email
- jerzymackiewicz@umlub.pl
- Contact Person Name
- Jerzy Mackiewicz
- Contact Person Email
- jerzymackiewicz@umlub.pl
- Site Name
- Centrum Medyczne Piasta 47 Sp. z o.o.
- Department Name
- Centrum Medyczne Piasta 47
- Principal Investigator Name
- Ewa Fluder
- Principal Investigator Email
- jevick76@gmail.com
- Contact Person Name
- Ewa Fluder
- Contact Person Email
- jevick76@gmail.com
- Site Name
- Oftalmika Sp. z o.o.
- Department Name
- OFTALMIKA Sp. z o.o.
- Principal Investigator Name
- Jakub Kałużny
- Principal Investigator Email
- jjkaluzny@oftalmika.pl
- Contact Person Name
- Jakub Kałużny
- Contact Person Email
- jjkaluzny@oftalmika.pl
- Site Name
- Szpital Sw. Rozy Sp. z o.o.
- Department Name
- N/D
- Principal Investigator Name
- Malgorzata Siewierska
- Principal Investigator Email
- szpital@swroza.pl
- Contact Person Name
- Malgorzata Siewierska
- Contact Person Email
- szpital@swroza.pl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 07-05-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 358
- Number Of Sites
- 8
- Number Of Participants
- 40
Sites
- Site Name
- F D Roosevelt University General Hospital Of Banska Bystrica
- Department Name
- II. ocna Klinika SZU
- Principal Investigator Name
- Ladislav Janco
- Principal Investigator Email
- ljanco@nspbb.sk
- Contact Person Name
- Ladislav Janco
- Contact Person Email
- ljanco@nspbb.sk
- Site Name
- Nemocnica Poprad a.s.
- Department Name
- ocne oddelenie
- Principal Investigator Name
- Livia JAVORSKA
- Principal Investigator Email
- javorskalivia@gmail.com
- Contact Person Name
- Livia JAVORSKA
- Contact Person Email
- javorskalivia@gmail.com
- Site Name
- Nemocnica S Poliklinikou Trebisov a.s.
- Department Name
- Oftalmologicka ambulancia III.
- Principal Investigator Name
- Maria Hurcikova
- Principal Investigator Email
- maria.hurcikova@pentahospitals.sk
- Contact Person Name
- Maria Hurcikova
- Contact Person Email
- maria.hurcikova@pentahospitals.sk
- Site Name
- University Hospital Bratislava
- Department Name
- ocna klinika SZU a UNB
- Principal Investigator Name
- Nora Majtanova
- Principal Investigator Email
- nora.majtanova@gmail.com
- Contact Person Name
- Nora Majtanova
- Contact Person Email
- nora.majtanova@gmail.com
- Site Name
- Euromedix a.s.
- Department Name
- Oftalmologicka ambulancia
- Principal Investigator Name
- Jana Stefanickova
- Principal Investigator Email
- jstefanicka@gmail.com
- Contact Person Name
- Jana Stefanickova
- Contact Person Email
- jstefanicka@gmail.com
- Site Name
- 3 F s.r.o.
- Department Name
- Mikrochirurgia oka
- Principal Investigator Name
- Frantisek Daboczi
- Principal Investigator Email
- 3f@bnc.sk
- Contact Person Name
- Frantisek Daboczi
- Contact Person Email
- 3f@bnc.sk
- Site Name
- Fakultna Nemocnica Nitra
- Department Name
- ocna klinika
- Principal Investigator Name
- Gabriela Pavlovicova
- Principal Investigator Email
- gabrielapavlovicova11@gmail.com
- Contact Person Name
- Gabriela Pavlovicova
- Contact Person Email
- gabrielapavlovicova11@gmail.com
- Site Name
- Robin Look spol. s r.o.
- Principal Investigator Name
- Pavol Kusenda
- Principal Investigator Email
- pavol.kusenda@gmail.com
- Contact Person Name
- Pavol Kusenda
- Contact Person Email
- pavol.kusenda@gmail.com
Sponsor
Primary sponsor
- Full Name
- Eyepoint Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Merit CRO Inc.
- Responsibilities
- codes: 15; value: Imaging Center
- Name
- Ppd Inc.
- Responsibilities
- codes: 4
- Name
- Syneos Health UK Limited
- Responsibilities
- codes: 1,10,11,13,15,2,5,6,7,8,9; value: Secondary Vendors Management
- Name
- Almac Clinical Services LLC
- Responsibilities
- codes: 14
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"codes: 15; value: Equipment rental","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"codes: 1,10,11,13,15,2,5,6,7,8,9; value: Secondary Vendors Management","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Neonstone Limited","duties_or_roles":"codes: 15; value: site facing recruitment/pre-screening/local ad portal","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"codes: 15; value: VFE (BCVA) & Room/Lane Certification","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"codes: 15; value: Imaging Center","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- EYP-1901
- Active Substance
- vorolanib
- Modality
- Small molecule
- Routes Of Administration
- INTRAVITREAL USE
- Route
- INTRAVITREAL USE
- Authorisation Status
- Investigational / no marketing authorisation listed in record
- Starting Dose
- 2686 µg
- Dose Levels
- 2686 µg
- Maximum Dose
- 10744 µg
- Investigational Product Name
- Eylea 40 mg/mL solution for injection in pre-filled syringe.
- Active Substance
- aflibercept
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVITREAL USE
- Route
- INTRAVITREAL USE
- Authorisation Status
- Authorised - marketing authorisation EU/1/12/797/001 (Bayer AG)
- Starting Dose
- 2 mg
- Dose Levels
- 2 mg (maxDailyDoseAmount as provided in record)
- Maximum Dose
- 26 mg
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