Clinical trial • Phase II • Ophthalmology

XELAFASLATIDE for Atrophic age-related macular degeneration (geographic atrophy)

Phase II trial of XELAFASLATIDE for Atrophic age-related macular degeneration (geographic atrophy).

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Atrophic age-related macular degeneration (geographic atrophy)
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme|Other

Key dates

Initial CTIS Submission Date
14-04-2025
First CTIS Authorization Date
05-08-2025

Trial design

Randomised, sham injection (placebo) — sham intravitreal injection; dose/schedule not specified-controlled Phase II trial across 64 sites in Spain, Portugal, Germany and others.

Randomised
Yes
Comparator
Sham injection (placebo) — sham intravitreal injection; dose/schedule not specified
Target Sample Size
142
Trial Duration For Participant
60

Eligibility

Recruits 142 Vulnerable populations selected (isVulnerablePopulationSelected: true). No further explicit details on consent or assent handling are provided in the available metadata/documents..

Pregnancy Exclusion
Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period.
Vulnerable Population
Vulnerable populations selected (isVulnerablePopulationSelected: true). No further explicit details on consent or assent handling are provided in the available metadata/documents.

Inclusion criteria

  • {"criterion_text":"- 55 years of age or older at Screening."}
  • {"criterion_text":"- If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar [see Protocol for formulation]) nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or similar, patient must be willing to continue not to use therapy for the duration of the study. Patient must agree to choose either approach."}
  • {"criterion_text":"- Non-foveal GA associated with AMD without eMNV in the study eye per Investigator’s evaluation and as confirmed by the central RC."}
  • {"criterion_text":"- BCVA of 24 letters or more using ETDRS charts in the study eye at Screening."}
  • {"criterion_text":"- BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening."}

Exclusion criteria

  • {"criterion_text":"- Any ocular or systemic condition that, in the opinion of the Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study."}
  • {"criterion_text":"- Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period."}
  • {"criterion_text":"- Previous IVT pharmaceutical treatment in the study eye with any agent except regionally approved complement inhibitors and treatment with regionally approved complement inhibitors within 12 weeks prior to Screening."}
  • {"criterion_text":"- Any current evidence or history in the study eye of exudative (“wet”) AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator’s evaluation and confirmed by the central RC."}
  • {"criterion_text":"- Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 13 and 14 pertaining to retinal and glaucoma surgery, respectively."}
  • {"criterion_text":"- Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than regionally approved complement inhibitors during the study period."}
  • {"criterion_text":"- Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye."}
  • {"criterion_text":"- GA in either eye due to causes other than AMD."}
  • {"criterion_text":"- Any ophthalmic condition in either eye that is likely to require surgery during the study period."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- GA lesion area assessment","definition_or_measurement_approach":"No explicit endpoint definition provided in the endpoint listing. Imaging modalities listed in sponsor/third-party duties (FAF, FP, FA, OCT, OCTA and AI imaging) are available and likely used for lesion area assessment."}

Recruitment

Registry Or Advocacy Recruitment
True; Fundacion De Oftalmologia Medica De La Comunitat Valenciana; Konvent Der Barmherzigen Brueder
Digital Remote Recruitment
True; PatientGO app materials, advocacy PAG enewsletters, online clinical trial listing and digital patient brochures
Planned Sample Size
142
Recruitment Window Months
31
Consent Approach
Written informed consent obtained from participating subjects. Study ICF (L1_SIS and ICF) documents and related subject information are provided in multiple language versions (examples in the dossier: English, Spanish, Italian, Polish, Portuguese, Greek, Hungarian, Czech). Pregnancy-specific ICFs and 'Pregnant Partner' ICFs are included where relevant. No assent process described (participants are adults).

Methods

  • Posters with flyer (document titles: poster with flyer / poster_with_flyer)
  • Dr-to-patient letters (dr_to_pt_letter)
  • Dr-to-dr letters (dr to dr letter)
  • Patient brochures (patient brochure / Patient_Brochure)
  • Clinical trial listing / clinical trial listing documents
  • Advocacy / PAG enewsletter content (advocacy PAG enewsletter content)
  • Lunch and Learn slides
  • Visit reminder cards
  • PatientGO app materials (PatientGO App, EULA, Privacy Policy)

Geography

Total Number Of Sites
64
Total Number Of Participants
182

Spain

Earliest CTIS Part Ii Submission Date
03-07-2025
Latest Decision Or Authorization Date
08-08-2025
Processing Time Days
36
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Fundacion De Oftalmologia Medica De La Comunitat Valenciana
Department Name
Ophthalmology
Principal Investigator Name
Maria Carmen Desco Esteban
Principal Investigator Email
carmen.desco@uv.es
Contact Person Name
Maria Carmen Desco Esteban
Contact Person Email
carmen.desco@uv.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Ophthalmology
Principal Investigator Name
Estanislao Gutiérrez Sánchez
Principal Investigator Email
esgusan@hotmail.com
Contact Person Name
Estanislao Gutiérrez Sánchez
Contact Person Email
esgusan@hotmail.com
Site Name
Clinica De Oftalmologia De Cordoba S.L.
Department Name
Ophthalmology
Principal Investigator Name
Juan Manuel Cubero Parra
Principal Investigator Email
jmcp@hospitalarruzafa.com
Contact Person Name
Juan Manuel Cubero Parra
Contact Person Email
jmcp@hospitalarruzafa.com
Site Name
Centro De Oftalmologia Barraquer S.A.
Department Name
Ophthalmology
Principal Investigator Name
Santiago Abengoechea Hernandez
Principal Investigator Email
sah@barraquer.com
Contact Person Name
Santiago Abengoechea Hernandez
Contact Person Email
sah@barraquer.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Ophthalmology
Principal Investigator Name
José María Ruiz Moreno
Principal Investigator Email
josemaria.ruiz@uclm.es
Contact Person Name
José María Ruiz Moreno
Contact Person Email
josemaria.ruiz@uclm.es
Site Name
Hospital Universitario Miguel Servet
Department Name
Ophthalmology
Principal Investigator Name
Luis Emilio Pablo Júlvez
Principal Investigator Email
lpablo@unizar.es
Contact Person Name
Luis Emilio Pablo Júlvez
Contact Person Email
lpablo@unizar.es
Site Name
Bilboftal S.L.
Department Name
Ophthalmology
Principal Investigator Name
José Javier Araiz Iribarren
Principal Investigator Email
araiz@icqo.org
Contact Person Name
José Javier Araiz Iribarren
Contact Person Email
araiz@icqo.org
Site Name
Institut Catala De Retina S.L.
Department Name
Ophthalmology
Principal Investigator Name
Ignasi Jürgens Mestre
Principal Investigator Email
ignasi.jurgens@icrcat.com
Contact Person Name
Ignasi Jürgens Mestre
Contact Person Email
ignasi.jurgens@icrcat.com
Site Name
Clinica De Oftalmologia De Cordoba S.L. (duplicate entry not expected?)
Department Name
Ophthalmology
Principal Investigator Name
Juan Manuel Cubero Parra
Principal Investigator Email
jmcp@hospitalarruzafa.com
Contact Person Name
Juan Manuel Cubero Parra
Contact Person Email
jmcp@hospitalarruzafa.com

Portugal

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
06-08-2025
Processing Time Days
61
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Ophthalmology
Principal Investigator Name
Cláudia Farinha
Principal Investigator Email
claudia.farinha@hotmail.com
Contact Person Name
Cláudia Farinha
Contact Person Email
claudia.farinha@hotmail.com
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Ophthalmology
Principal Investigator Name
Catarina Ferreira
Principal Investigator Email
catarina.ferreira@ulsge.min-saude.pt
Contact Person Name
Catarina Ferreira
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Ophthalmology
Principal Investigator Name
Miguel Lume
Contact Person Name
Miguel Lume
Site Name
Association For Innovation And Biomedical Research On Light And Image
Department Name
Ophthalmology
Principal Investigator Name
Inês Marques
Principal Investigator Email
ipmarques@aibili.pt
Contact Person Name
Inês Marques
Contact Person Email
ipmarques@aibili.pt

Germany

Earliest CTIS Part Ii Submission Date
09-07-2025
Latest Decision Or Authorization Date
05-08-2025
Processing Time Days
27
Number Of Sites
11
Number Of Participants
19

Sites

Site Name
Universitaetsklinikum Bonn AöR
Department Name
Dep. Of Ophtolmology
Principal Investigator Name
Kristina Pfau
Principal Investigator Email
Kristina.Pfau@ukbonn.de
Contact Person Name
Kristina Pfau
Contact Person Email
Kristina.Pfau@ukbonn.de
Site Name
Augenzentrum Prof. Dr. Koch GmbH
Principal Investigator Name
Frank Koch
Principal Investigator Email
f.koch@azffm.de
Contact Person Name
Frank Koch
Contact Person Email
f.koch@azffm.de
Site Name
Augen-Zentrum-Nordwest
Principal Investigator Name
Greta Stefanie Schmickler
Principal Investigator Email
st.schmickler@augen-zentrum-nordwest.de
Contact Person Name
Greta Stefanie Schmickler
Site Name
Universitaetsklinikum Aachen AöR
Principal Investigator Name
Sabine Baumgarten
Principal Investigator Email
sabaumgarten@ukaachen.de
Contact Person Name
Sabine Baumgarten
Contact Person Email
sabaumgarten@ukaachen.de
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Walter Sekundo
Principal Investigator Email
walter.sekundo@staff.uni-marburg.de
Contact Person Name
Walter Sekundo
Site Name
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)
Principal Investigator Name
Hakan Kaymak
Principal Investigator Email
studien.h.kaymak@augenchirurgie.clinic
Contact Person Name
Hakan Kaymak
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Augen- und Poliklinik / Raum 0171
Principal Investigator Name
Andreas Berlin
Principal Investigator Email
berlin_a@ukw.de
Contact Person Name
Andreas Berlin
Contact Person Email
berlin_a@ukw.de
Site Name
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.) (Duesseldorf - Oberkassel)
Principal Investigator Name
Hakan Kaymak
Principal Investigator Email
studien.h.kaymak@augenchirurgie.clinic
Contact Person Name
Hakan Kaymak
Site Name
Dr. med. Stefan Scholl und Prof. Dr. med. Albert J. Augustin Augenarztpraxis
Principal Investigator Name
Albert Augustin
Principal Investigator Email
albertjaugustin@gmail.com
Contact Person Name
Albert Augustin
Contact Person Email
albertjaugustin@gmail.com
Site Name
Universitaetsklinikum Bonn AöR (duplicate entry not expected?)
Department Name
Dep. Of Ophtolmology
Principal Investigator Name
Kristina Pfau
Principal Investigator Email
Kristina.Pfau@ukbonn.de
Contact Person Name
Kristina Pfau
Contact Person Email
Kristina.Pfau@ukbonn.de
Site Name
Augenzentrum Prof. Dr. Koch GmbH (duplicate entry)
Principal Investigator Name
Frank Koch
Principal Investigator Email
f.koch@azffm.de
Contact Person Name
Frank Koch
Contact Person Email
f.koch@azffm.de

Greece

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
13
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
General Hospital Of Athens G Gennimatas
Department Name
1st University Eye Clinic
Principal Investigator Name
Ilias Georgalas
Principal Investigator Email
igeorgalas@yahoo.gr
Contact Person Name
Ilias Georgalas
Contact Person Email
igeorgalas@yahoo.gr
Site Name
General University Hospital Of Patras
Department Name
Ophthalmology Clinic
Principal Investigator Name
Konstantinos Georgakopoulos
Principal Investigator Email
cgeorg@med.upatras.gr
Contact Person Name
Konstantinos Georgakopoulos
Contact Person Email
cgeorg@med.upatras.gr
Site Name
University General Hospital Of Ioannina
Department Name
Ophthalmologic Clinic
Principal Investigator Name
Asproudis Ioannis
Principal Investigator Email
asproudisi@yahoo.gr
Contact Person Name
Asproudis Ioannis
Contact Person Email
asproudisi@yahoo.gr
Site Name
University General Hospital Of Heraklion
Department Name
Ophthalmology Clinic
Principal Investigator Name
Tsilimbaris Miltiadis
Principal Investigator Email
tsilimb@med.uoc.gr
Contact Person Name
Tsilimbaris Miltiadis
Contact Person Email
tsilimb@med.uoc.gr
Site Name
University General Hospital Attikon
Department Name
2nd Department of Opthalmology,"University of Athens"
Principal Investigator Name
Irini Chatziralli
Principal Investigator Email
eirchat@yahoo.gr
Contact Person Name
Irini Chatziralli
Contact Person Email
eirchat@yahoo.gr

Poland

Earliest CTIS Part Ii Submission Date
01-07-2025
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
41
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Optimum Profesorskie Centrum Okulistyki Sp. z o.o.
Principal Investigator Name
Dorota Raczynska
Principal Investigator Email
draczynska@op.pl
Contact Person Name
Dorota Raczynska
Contact Person Email
draczynska@op.pl
Site Name
Klinika Okulistyczna Jasne Blonia Sp. z o.o.
Principal Investigator Name
Zofia Nawrocka
Principal Investigator Email
jasneblonia@interia.pl
Contact Person Name
Zofia Nawrocka
Contact Person Email
jasneblonia@interia.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Principal Investigator Name
Bożena Romanowska-Dixon
Principal Investigator Email
bromanowska@su.krakow.pl
Contact Person Name
Bożena Romanowska-Dixon
Contact Person Email
bromanowska@su.krakow.pl
Site Name
Szpital Sw. Rozy Sp. z o.o. S.K.
Principal Investigator Name
Małgorzata Siewierska
Principal Investigator Email
szpital@swroza.pl
Contact Person Name
Małgorzata Siewierska
Contact Person Email
szpital@swroza.pl
Site Name
Oculomedica Sp. z o.o.
Principal Investigator Name
Bartosz Sikorski
Principal Investigator Email
sikorski@doctors.org.uk
Contact Person Name
Bartosz Sikorski
Contact Person Email
sikorski@doctors.org.uk
Site Name
Centrum Diagnostyki I 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
Bonifraterskie Centrum Medyczne Sp. z o.o.
Department Name
Poradnia Okulistyczna
Principal Investigator Name
Dominik Odrobina
Principal Investigator Email
lodz@bcmbonifratrzy.pl
Contact Person Name
Dominik Odrobina
Contact Person Email
lodz@bcmbonifratrzy.pl
Site Name
Centrum Medyczne Dietla 19 Sp. z o.o.
Principal Investigator Name
Piotr Oleksy
Principal Investigator Email
piotroleksy@yahoo.pl
Contact Person Name
Piotr Oleksy
Contact Person Email
piotroleksy@yahoo.pl
Site Name
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. (duplicate)
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
Optimum Profesorskie Centrum Okulistyki Sp. z o.o. (duplicate)
Principal Investigator Name
Dorota Raczynska
Principal Investigator Email
draczynska@op.pl
Contact Person Name
Dorota Raczynska
Contact Person Email
draczynska@op.pl

Austria

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
49
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Konvent Der Barmherzigen Brueder
Department Name
Abteilung für Augenheilkunde
Principal Investigator Name
Peter Reinelt
Principal Investigator Email
p.reinelt@bblinz.at
Contact Person Name
Peter Reinelt
Contact Person Email
p.reinelt@bblinz.at
Site Name
Institut Fuer Forschung Und Innovation In Der Augenchirurgie
Principal Investigator Name
Oliver Findl
Principal Investigator Email
oliver@findl.at
Contact Person Name
Oliver Findl
Contact Person Email
oliver@findl.at
Site Name
Medical University Of Vienna
Department Name
Department of Ophthalmology and Optometry
Principal Investigator Name
Stefan Sacu
Principal Investigator Email
stefan.sacu@meduniwien.ac.at
Contact Person Name
Stefan Sacu
Contact Person Email
stefan.sacu@meduniwien.ac.at

Italy

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
06-08-2025
Processing Time Days
61
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento di Medicina Sperimentale e Clinica, Clinica Oculistica
Principal Investigator Name
Marco Lupidi
Principal Investigator Email
marco.lupidi@ospedaliriuniti.marche.it
Contact Person Name
Marco Lupidi
Site Name
ASST Fatebenefratelli Sacco
Department Name
Dipartimento di Scienze Cliniche e Biomediche
Principal Investigator Name
Giovanni Staurenghi
Principal Investigator Email
giovanni.staurenghi@unimi.it
Contact Person Name
Giovanni Staurenghi
Contact Person Email
giovanni.staurenghi@unimi.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
U.O. Oftalmologia
Principal Investigator Name
Antonio Pasquale Ciardella
Principal Investigator Email
antonio.ciardella@aosp.bo.it
Contact Person Name
Antonio Pasquale Ciardella
Contact Person Email
antonio.ciardella@aosp.bo.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Experimental Medicine
Principal Investigator Name
Federico Ricci
Principal Investigator Email
federico.ricci@uniroma2.it
Contact Person Name
Federico Ricci
Contact Person Email
federico.ricci@uniroma2.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oculistica
Principal Investigator Name
Stanislao Rizzo
Principal Investigator Email
stanislao.rizzo@policlinicogemelli.it201
Contact Person Name
Stanislao Rizzo
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Ophthalmology
Principal Investigator Name
Grazia Pertile
Principal Investigator Email
grazia.pertile@sacrocuore.it
Contact Person Name
Grazia Pertile
Contact Person Email
grazia.pertile@sacrocuore.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Deptartment Surgical Sciences
Principal Investigator Name
Chiara Maria Eandi
Principal Investigator Email
chiara.eandi@unito.it
Contact Person Name
Chiara Maria Eandi
Contact Person Email
chiara.eandi@unito.it

Hungary

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
07-08-2025
Processing Time Days
56
Number Of Sites
10
Number Of Participants
36

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
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
Semmelweis University
Department Name
Ophtalmology
Principal Investigator Name
András Papp
Principal Investigator Email
papp.andras1@med.semmelweis-univ.hu
Contact Person Name
András Papp
Site Name
University Of Debrecen
Department Name
Ophtalmology
Principal Investigator Name
Attila Vajas
Principal Investigator Email
vajasa@gmail.com
Contact Person Name
Attila Vajas
Contact Person Email
vajasa@gmail.com
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
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
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
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
Site Name
Semmelweis University (duplicate entry)
Department Name
Ophtalmology
Principal Investigator Name
András Papp
Principal Investigator Email
papp.andras1@med.semmelweis-univ.hu
Contact Person Name
András Papp
Site Name
Central Hospital Of Northern Pest Military Hospital (duplicate)
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

Czechia

Earliest CTIS Part Ii Submission Date
30-04-2025
Latest Decision Or Authorization Date
06-08-2025
Processing Time Days
98
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Visus spol. s r.o.
Principal Investigator Name
Jan Studnicka
Principal Investigator Email
jan.studnicka@post.cz
Contact Person Name
Jan Studnicka
Contact Person Email
jan.studnicka@post.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Oftalmologicka klinika
Principal Investigator Name
Jan Hamouz
Principal Investigator Email
jan.hamouz@fnkv.cz
Contact Person Name
Jan Hamouz
Contact Person Email
jan.hamouz@fnkv.cz
Site Name
Medical Private Care s.r.o.
Principal Investigator Name
Andrej Farkas
Principal Investigator Email
andrej.farkas@nemocnicesokolov.cz
Contact Person Name
Andrej Farkas
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
Vseobecna Fakultni Nemocnice V Praze
Department Name
Ocni klinika
Principal Investigator Name
Bohdan Kousal
Principal Investigator Email
bohdan.kousal@vfn.cz
Contact Person Name
Bohdan Kousal
Contact Person Email
bohdan.kousal@vfn.cz

Sponsor

Primary sponsor

Full Name
ONL Therapeutics Inc.
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: 1,10,11,12,13,14,2,3,5,6,7,8
Name
Syneos Health Hellas Single Member S.A.
Responsibilities
sponsorDuties codes: 1,12,2,5

Third parties

  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Doheny Eye Institute","duties_or_roles":"Imaging: FAF, FP, FA, OCT, OCTA","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"AI Imaging","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,14,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12,2,5","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ONL1204 Ophthalmic Solution
Active Substance
XELAFASLATIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVITREAL USE
Route
Intravitreal
Maximum Dose
1200 µg (total)
Investigational Product Name
Sham injection
Modality
Other

Related trials

Other published trials that may interest you.