Clinical trial • Phase II/III • Ophthalmology

EYE103 for Diabetic macular edema

Phase II/III trial of EYE103 for Diabetic macular edema.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Diabetic macular edema
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
18-07-2024
First CTIS Authorization Date
11-11-2024

Trial design

Randomised, intravitreal ranibizumab (lucentis) 0.5 mg (intravitreal); schedule not specified in provided documents-controlled Phase II/III trial in France, Slovakia, Latvia and others.

Randomised
Yes
Comparator
Intravitreal ranibizumab (Lucentis) 0.5 mg (intravitreal); schedule not specified in provided documents
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
375
Trial Duration For Participant
365

Eligibility

Recruits 375 No vulnerable population selected. Participants must be ≥18 years of age and provide written informed consent prior to the first study-related activity. Subject information sheets (SIS) and informed consent forms (ICF), including ICFs for pregnant partners, are provided and uploaded in multiple country-specific translations..

Pregnancy Exclusion
Participants must not: Be pregnant or breastfeeding.
Vulnerable Population
No vulnerable population selected. Participants must be ≥18 years of age and provide written informed consent prior to the first study-related activity. Subject information sheets (SIS) and informed consent forms (ICF), including ICFs for pregnant partners, are provided and uploaded in multiple country-specific translations.

Inclusion criteria

  • {"criterion_text":"- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity\n- Be male or female ≥ 18 years of age\n- If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential (defined as any female who has begun menstruation and who is not permanently sterile, and is not postmenopausal [defined as a female who has not had a menstrual period for at least 12 months without an alternative medical cause]); such participants must agree to use an acceptable method of contraception for 3 months after the last dose of study drug.\n- If male, be surgically sterile for at least 12 weeks, or agree to use an acceptable method of contraception, such as a condom, and a second highly effective method of contraception (see Appendix F) from Screening up to and including 90 days after the last dose of study drug"}

Exclusion criteria

  • {"criterion_text":"- Participants must not: Be pregnant or breastfeeding.\n- Have had vitrectomy in the study eye.\n- Have known or former myopia with a spherical equivalent of >8 diopters.\n- Have had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis at any time during the study.\n- Have active retinal disease other than the condition (DME/diabetic retinopathy) under investigation in the study eye.\n- Have any history or evidence of a concurrent ocular condition present in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study\n- Have active or suspected ocular or periocular infection or inflammation in either eye at Day 1.\n- Currently have evidence of, or a history of any clinically significant autoimmune, cardiovascular, hematologic, hepatic, metabolic, peripheral vascular, renal, or respiratory disease, which, in the opinion of the Investigator, would exclude the participant from this study.\n- Have a known hypersensitivity to any of the components of EYE103 formulation or prior hypersensitivity to monoclonal antibodies (mAbs).\n- Have previously participated in any study of EYE103\n- Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest\n- Have advanced or uncontrolled glaucoma in the study eye.\n- Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day 1.\n- Are currently using of drugs with known retinal toxicity\n- Have history of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) in the study eye within 90 days of Screening.\n- Have any treatment for complications of cataract surgery with steroids or Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 90 days of Screening.\n- Have had Pan-retinal Photocoagulation (PRP) or focal/grid thermal laser photocoagulation in the study eye within 90 days of Screening.\n- Have tractional retinal detachment in the study eye.\n- Have any active malignancy\n- Have any history of organ transplant\n- Any ilicit drug use in the past 1 year\n- Had prior IVT complement inhibitors in either eye at any time\n- Have had glaucoma-filtering surgery (trabeculectomy or tube shunt) in the study eye.\n- Have any history of retinal detachment or treatment or surgery for retinal detachment in the study eye.\n- Have any history of uveitis in either eye.\n- Have significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, OCT, or fundus photography in the opinion of the reading center.\n- Have a cataract in the study eye that in the judgment of the Investigator is expected to require surgical extraction within 4 months of Screening.\n- Have aphakia in the study eye.\n- Have allergy to fluorescein dye."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).","definition_or_measurement_approach":"Mean change in best-corrected visual acuity (BCVA) measured using the standardized ETDRS chart from Day 1 to Year 1 (average of Weeks 48 and 52)."}

Recruitment

Registry Or Advocacy Recruitment
True, Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Planned Sample Size
375
Recruitment Window Months
36
Consent Approach
Written informed consent is required from each participant (participants must be ≥18 years old). Subject information sheets (SIS) and informed consent forms (ICF), including ICFs for pregnant partners, are provided and uploaded as trial documents in multiple country-specific translations.

Geography

Total Number Of Sites
68
Total Number Of Participants
585

France

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
46
Number Of Sites
8
Number Of Participants
50

Sites

Site Name
Fondation A De Rothschild
Department Name
Ophtalmology
Principal Investigator Name
Youssef Abdel Massih
Principal Investigator Email
yabdelmassih@for.paris
Contact Person Name
Youssef Abdel Massih
Contact Person Email
yabdelmassih@for.paris
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Ophtalmology
Principal Investigator Name
Catherine Creuzot-Garcher
Principal Investigator Email
catherine.creuzot-garcher@chu-dijon.fr
Contact Person Name
Catherine Creuzot-Garcher
Site Name
Centre Monticelli Paradis D Ophtalmologie
Department Name
Ophtalmology
Principal Investigator Name
François Devin
Principal Investigator Email
fdbm.retine@gmail.com
Contact Person Name
François Devin
Contact Person Email
fdbm.retine@gmail.com
Site Name
Hospices Civils De Lyon
Department Name
Ophtalmology
Principal Investigator Name
Laurent Kodjikian
Principal Investigator Email
laurent.kodjikian@chu-lyon.fr
Contact Person Name
Laurent Kodjikian
Contact Person Email
laurent.kodjikian@chu-lyon.fr
Site Name
Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic
Department Name
Ophtalmology
Principal Investigator Name
Catherine Français-Maury
Principal Investigator Email
catherinefrancais@gmail.com
Contact Person Name
Catherine Français-Maury
Contact Person Email
catherinefrancais@gmail.com
Site Name
Retina
Department Name
Ophtalmology
Principal Investigator Name
Sam Razavi
Principal Investigator Email
razavisam3@gmail.com
Contact Person Name
Sam Razavi
Contact Person Email
razavisam3@gmail.com
Site Name
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L.
Department Name
Ophtalmology
Principal Investigator Name
Gabriel Quentel
Principal Investigator Email
gabriel.quentel@cil-paris.fr
Contact Person Name
Gabriel Quentel
Contact Person Email
gabriel.quentel@cil-paris.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Ophtalmology
Principal Investigator Name
Eric Souied
Principal Investigator Email
eric.souied@chicreteil.fr
Contact Person Name
Eric Souied
Contact Person Email
eric.souied@chicreteil.fr

Slovakia

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
17
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Vesely Ocna klinika
Department Name
Ophtalmology
Principal Investigator Name
Katarina Struharova
Principal Investigator Email
katarina.struharova@veselyok.com
Contact Person Name
Katarina Struharova
Site Name
Fakultna Nemocnica S Poliklinikou Zilina
Department Name
Ophtalmology
Principal Investigator Name
Blandina Lipkova
Principal Investigator Email
blandina.lipkova@gmail.com
Contact Person Name
Blandina Lipkova
Contact Person Email
blandina.lipkova@gmail.com
Site Name
Nemocnica S Poliklinikou Trebisov a.s.
Department Name
Ophtalmology
Principal Investigator Name
Maria Hurcikova
Principal Investigator Email
maria.hurcikova@pentahospitals.sk
Contact Person Name
Maria Hurcikova
Site Name
Fakultna Nemocnica Trencín
Department Name
Ophtalmology
Principal Investigator Name
Marek Kacerik
Principal Investigator Email
marek.kacerik@tntn.sk
Contact Person Name
Marek Kacerik
Contact Person Email
marek.kacerik@tntn.sk

Latvia

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
15-11-2024
Processing Time Days
31
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Ophtalmology
Principal Investigator Name
Guna Laganovska
Principal Investigator Email
glaganovska@ml.lv
Contact Person Name
Guna Laganovska
Contact Person Email
glaganovska@ml.lv
Site Name
Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki"
Department Name
Ophtalmology
Principal Investigator Name
Kristine Baumane
Principal Investigator Email
baumanek@ml.lv
Contact Person Name
Kristine Baumane
Contact Person Email
baumanek@ml.lv

Italy

Earliest CTIS Part Ii Submission Date
03-10-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
39
Number Of Sites
10
Number Of Participants
70

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
Ophtalmology
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
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
Oftalmologia
Principal Investigator Name
Monica Varano
Principal Investigator Email
monica.varano@fondazionebietti.it
Contact Person Name
Monica Varano
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Ophtalmology
Principal Investigator Name
Federico Ricci
Principal Investigator Email
retina@ptvonline.it
Contact Person Name
Federico Ricci
Contact Person Email
retina@ptvonline.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Ophtalmology
Principal Investigator Name
Paolo Lanzetta
Principal Investigator Email
paolo.lanzetta@uniud.it
Contact Person Name
Paolo Lanzetta
Contact Person Email
paolo.lanzetta@uniud.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Ophtalmology
Principal Investigator Name
Francesco Maria Bandello
Principal Investigator Email
bandello.francesco@hsr.it
Contact Person Name
Francesco Maria Bandello
Contact Person Email
bandello.francesco@hsr.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ophtalmology
Principal Investigator Name
Francesco Viola
Principal Investigator Email
francesco.viola@unimi.it
Contact Person Name
Francesco Viola
Contact Person Email
francesco.viola@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ophtalmology
Principal Investigator Name
Stanislao Rizzo
Principal Investigator Email
stanislao.rizzo@policlinicogemelli.it
Contact Person Name
Stanislao Rizzo
Site Name
Careggi University Hospital
Department Name
Ophtalmology
Principal Investigator Name
Gianni Virgili
Principal Investigator Email
gianni.virgili@unifi.it
Contact Person Name
Gianni Virgili
Contact Person Email
gianni.virgili@unifi.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Ophtalmology
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
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Ophtalmology
Principal Investigator Name
Antonio Ciardella
Principal Investigator Email
antonio.ciardella@aosp.bo.it
Contact Person Name
Antonio Ciardella
Contact Person Email
antonio.ciardella@aosp.bo.it

Spain

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
15-11-2024
Processing Time Days
101
Number Of Sites
9
Number Of Participants
50

Sites

Site Name
Valles Ophthalmology Research S.L.
Department Name
Ophtalmology
Principal Investigator Name
Laura Sarasols Ramsay
Principal Investigator Email
sararols.laura@hotmail.com
Contact Person Name
Laura Sarasols Ramsay
Contact Person Email
sararols.laura@hotmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Ophtalmology
Principal Investigator Name
Francisco Javier Ascaso
Principal Investigator Email
jascaso@gmail.com
Contact Person Name
Francisco Javier Ascaso
Contact Person Email
jascaso@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Ophtalmology
Principal Investigator Name
Marta Garrido Marín
Principal Investigator Email
marta.garridomarin@vallhebron.cat
Contact Person Name
Marta Garrido Marín
Site Name
Centro De Oftalmologia Barraquer S.A.
Department Name
Ophthalmogoly
Principal Investigator Name
Santiago Abengoechea
Principal Investigator Email
victoria.hernandez@barraquer.com
Contact Person Name
Santiago Abengoechea
Site Name
Miranza Galicia S.L.
Department Name
Ophthalmogoly
Principal Investigator Name
Francisco Gomez-Ulla
Principal Investigator Email
clara.crespo@miranza.es
Contact Person Name
Francisco Gomez-Ulla
Contact Person Email
clara.crespo@miranza.es
Site Name
Oftalmologia Vistahermosa S.L.
Department Name
Ophtalmology
Principal Investigator Name
Roberto Gallego-Pinazo
Principal Investigator Email
robertogallegopinazo@gmail.com
Contact Person Name
Roberto Gallego-Pinazo
Contact Person Email
robertogallegopinazo@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Ophtalmology
Principal Investigator Name
Estanislao Gutiérrez
Principal Investigator Email
esgusan@hotmail.com
Contact Person Name
Estanislao Gutiérrez
Contact Person Email
esgusan@hotmail.com
Site Name
Institut Catala De Retina S.L.
Department Name
Ophtalmology
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
Instituto De Microcirugia Ocular Dos S.L.
Department Name
Ophthalmogoly
Principal Investigator Name
Anniken Bures
Principal Investigator Email
ana.nolla@imo.es
Contact Person Name
Anniken Bures
Contact Person Email
ana.nolla@imo.es

Czechia

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
27
Number Of Sites
5
Number Of Participants
120

Sites

Site Name
Oftex s.r.o.
Department Name
Ophtalmology
Principal Investigator Name
Vladimir Korda
Principal Investigator Email
korda@oftex.cz
Contact Person Name
Vladimir Korda
Contact Person Email
korda@oftex.cz
Site Name
Axon Clinical s.r.o.
Department Name
Ophtalmology
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
Oblastni nemocnice Mlada Boleslav a.s. nemocnice Stredoceskeho kraje
Department Name
Ophtalmology
Principal Investigator Name
Alexandr Stepanov
Principal Investigator Email
alexandr.stepanov@onmb.cz
Contact Person Name
Alexandr Stepanov
Contact Person Email
alexandr.stepanov@onmb.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Ophtalmology
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
Visus spol. s r.o.
Department Name
Ophtalmology
Principal Investigator Name
Jan Studnička
Principal Investigator Email
jan.studnicka@post.cz
Contact Person Name
Jan Studnička
Contact Person Email
jan.studnicka@post.cz

Germany

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
11
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Ophtalmology
Principal Investigator Name
Martin Spitzer
Principal Investigator Email
m.spitzer@uke.de
Contact Person Name
Martin Spitzer
Contact Person Email
m.spitzer@uke.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Ophtalmology
Principal Investigator Name
Mathias Maier
Principal Investigator Email
Roman.Miedl@mri.tum.de
Contact Person Name
Mathias Maier
Contact Person Email
Roman.Miedl@mri.tum.de
Site Name
Medizinische Hochschule Hannover
Department Name
Ophtalmology
Principal Investigator Name
Melanie Haar
Principal Investigator Email
haar.melanie@mh-hannover.de
Contact Person Name
Melanie Haar
Contact Person Email
haar.melanie@mh-hannover.de
Site Name
Ludwig-Maximilians-Universitaet Muenchen
Department Name
Ophtalmology
Principal Investigator Name
Tina Herold
Principal Investigator Email
Tina.herold@med.uni-muenchen.de
Contact Person Name
Tina Herold
Site Name
Augenzentrum Am St Franziskus-Hospital Muenster
Department Name
Ophtalmology
Principal Investigator Name
Georg Spital
Principal Investigator Email
georg.spital@augen-franziskus.de
Contact Person Name
Georg Spital
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Ophtalmology
Principal Investigator Name
Thomas Kohnen
Principal Investigator Email
jakob.wend@ukffm.de
Contact Person Name
Thomas Kohnen
Contact Person Email
jakob.wend@ukffm.de

Austria

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
35
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Medical University Of Graz
Department Name
Ophtalmology
Principal Investigator Name
Martin Weger
Principal Investigator Email
martin.weger@medunigraz.at
Contact Person Name
Martin Weger
Contact Person Email
martin.weger@medunigraz.at
Site Name
Medical University Of Vienna
Department Name
Ophtalmology and optometry
Principal Investigator Name
Andreas Pollreisz
Principal Investigator Email
andreas.pollreisz@meduniwien.ac.at
Contact Person Name
Andreas Pollreisz
Site Name
Institut Fuer Forschung Und Innovation In Der Augenchirurgie
Department Name
Macula/retina outpatient
Principal Investigator Name
Stephan Radda
Principal Investigator Email
office@viros.at
Contact Person Name
Stephan Radda
Contact Person Email
office@viros.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Ophtalmology
Principal Investigator Name
Matus Rehak
Principal Investigator Email
matus.rehak@i-med.ac.at
Contact Person Name
Matus Rehak
Contact Person Email
matus.rehak@i-med.ac.at

Portugal

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
98
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda.
Department Name
Ophtalmology
Principal Investigator Name
João Figueira
Principal Investigator Email
joaofigueira@oftalmologia.co.pt
Contact Person Name
João Figueira
Site Name
Association For Innovation And Biomedical Research On Light And Image
Department Name
Ophtalmology
Principal Investigator Name
Inês Dias Marques
Principal Investigator Email
ipmarques@aibili.pt
Contact Person Name
Inês Dias Marques
Contact Person Email
ipmarques@aibili.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Ophtalmology
Principal Investigator Name
Manuel Falcao
Principal Investigator Email
falcao@med.up.pt
Contact Person Name
Manuel Falcao
Contact Person Email
falcao@med.up.pt

Croatia

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
19-11-2024
Processing Time Days
46
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Klinicki Bolnicki Centar Osijek
Department Name
Ophtalmology
Principal Investigator Name
Mario Bradvica
Principal Investigator Email
mario.bradvica@vip.hr
Contact Person Name
Mario Bradvica
Contact Person Email
mario.bradvica@vip.hr

Hungary

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
15-11-2024
Processing Time Days
64
Number Of Sites
8
Number Of Participants
60

Sites

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
Central Hospital Of Northern Pest Military Hospital
Department Name
Ophtalmology
Principal Investigator Name
Gabor Vogt
Principal Investigator Email
gabor.vogt@tosho.hu
Contact Person Name
Gabor Vogt
Contact Person Email
gabor.vogt@tosho.hu
Site Name
University Of Szeged
Department Name
Ophtalmology
Principal Investigator Name
Edit Tóth-Molnár
Principal Investigator Email
tme@tmedit.hu
Contact Person Name
Edit Tóth-Molnár
Contact Person Email
tme@tmedit.hu
Site Name
Nozologen Kft.
Department Name
Ophtalmology
Principal Investigator Name
Balazs Varsanyi
Principal Investigator Email
varsanyi.balazs@gmail.com
Contact Person Name
Balazs Varsanyi
Contact Person Email
varsanyi.balazs@gmail.com
Site Name
Semmelweis University
Department Name
Ophtalmology
Principal Investigator Name
András Papp
Principal Investigator Email
drpapp55@gmail.com
Contact Person Name
András Papp
Contact Person Email
drpapp55@gmail.com
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
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
Zala Varmegyei Szent Rafael Korhaz
Department Name
Ophtalmology
Principal Investigator Name
Katalin Kiss
Principal Investigator Email
rezikiss@t-online.hu
Contact Person Name
Katalin Kiss
Contact Person Email
rezikiss@t-online.hu

Poland

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
19-12-2024
Processing Time Days
65
Number Of Sites
8
Number Of Participants
65

Sites

Site Name
Optimum Profesorskie Centrum Okulistyki Sp. z o.o.
Department Name
Ophtalmology
Principal Investigator Name
Dorota Raczyńska
Principal Investigator Email
draczynska@op.pl
Contact Person Name
Dorota Raczyńska
Contact Person Email
draczynska@op.pl
Site Name
Caminomed Sp. z o.o.
Department Name
Ophtalmology
Principal Investigator Name
Wojciech Jędrzejewski
Principal Investigator Email
caminomed.jedrzejewski@gmail.com
Contact Person Name
Wojciech Jędrzejewski
Site Name
Oculomedica Sp. z o.o.
Department Name
Ophtalmology
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.
Department Name
Ophtalmology
Principal Investigator Name
Dominik Zalewski
Principal Investigator Email
domizal@gmail.com
Contact Person Name
Dominik Zalewski
Contact Person Email
domizal@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Ophtalmology
Principal Investigator Name
Bożena Romanowska-Dixon
Principal Investigator Email
bkania@su.krakow.pl
Contact Person Name
Bożena Romanowska-Dixon
Contact Person Email
bkania@su.krakow.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Ophtalmology
Principal Investigator Name
Joanna Konopińska
Principal Investigator Email
joannakonopinska@o2.pl
Contact Person Name
Joanna Konopińska
Contact Person Email
joannakonopinska@o2.pl
Site Name
Oftalmika Sp. z o.o.
Department Name
Ophtalmology
Principal Investigator Name
Bartłomiej Kałużny
Principal Investigator Email
bartka@by.onet.pl
Contact Person Name
Bartłomiej Kałużny
Contact Person Email
bartka@by.onet.pl
Site Name
Gabinet Okulistyczny Prof Edward Wylegala
Department Name
Ophtalmology
Principal Investigator Name
Adam Wylegala
Principal Investigator Email
adam.wylegala@gmail.com
Contact Person Name
Adam Wylegala
Contact Person Email
adam.wylegala@gmail.com

Sponsor

Primary sponsor

Full Name
Eyebiotech Limited
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
United Kingdom

Contract research organisations

Name
International Drug Development Institute
Responsibilities
sponsorDuties codes: 10
Name
Almac Clinical Services Limited
Responsibilities
sponsorDuties codes: 14
Name
Acm Global Central Laboratory Limited
Responsibilities
sponsorDuties codes: 4
Name
TFS Trial Form Support AB
Responsibilities
sponsorDuties codes: 1,11,12,2,8

Third parties

  • {"country":"Belgium","full_name":"International Drug Development Institute","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Sweden","full_name":"TFS Trial Form Support AB","duties_or_roles":"sponsorDuties codes: 1,11,12,2,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
EYE103
Active Substance
EYE103
Modality
Monoclonal antibody
Routes Of Administration
Intravitreal use
Route
Intravitreal
Authorisation Status
Not authorised
Starting Dose
0.5 mg
Dose Levels
0.5 mg; 0.8 mg
Maximum Dose
0.8 mg
Investigational Product Name
Lucentis 10 mg/ml solution for injection
Active Substance
RANIBIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravitreal use
Route
Intravitreal
Authorisation Status
Authorised
Starting Dose
0.5 mg
Dose Levels
0.5 mg
Maximum Dose
0.5 mg
Investigational Product Name
Fluorescein Alcon® 10 % Injektionslösung
Active Substance
FLUORESCEIN SODIUM
Modality
Small molecule
Routes Of Administration
Solution for injection
Route
Injection (intravenous/ocular use as contrast agent) - route listed as solution for injection
Authorisation Status
Authorised
Maximum Dose
500 mg (as listed in product data)

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