Clinical trial • Phase III • Ophthalmology

ranibizumab for Neovascular age-related macular degeneration (nAMD)

Phase III trial of ranibizumab for Neovascular age-related macular degeneration (nAMD). open-label, none/not specified-controlled. 86 participants.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Neovascular age-related macular degeneration (nAMD)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-04-2025
First CTIS Authorization Date
22-08-2025

Trial design

open-label, none/not specified-controlled Phase III trial in Austria, Greece, Poland and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
86
Trial Duration For Participant
504

Eligibility

Recruits 86 Vulnerable population flag is selected (isVulnerablePopulationSelected: true). Subject information and consent documentation set includes caregiver and infant/newborn specific documents (e.g. 'Caregiver ICF', 'Infant authorization form', 'L1_SIS and ICF Pregnant Female', 'L1_SIS and ICF Newborn' and multiple caregiver/infant authorization templates). This indicates provisions for consent/authorization by caregivers or legal representatives where applicable and age-specific information/authorization documents are available in the submitted materials..

Vulnerable Population
Vulnerable population flag is selected (isVulnerablePopulationSelected: true). Subject information and consent documentation set includes caregiver and infant/newborn specific documents (e.g. 'Caregiver ICF', 'Infant authorization form', 'L1_SIS and ICF Pregnant Female', 'L1_SIS and ICF Newborn' and multiple caregiver/infant authorization templates). This indicates provisions for consent/authorization by caregivers or legal representatives where applicable and age-specific information/authorization documents are available in the submitted materials.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 50 years at time of signing Informed Consent Form"}
  • {"criterion_text":"- Initial diagnosis of nAMD within 24 months prior to the screening visit (according to recruitment strategy, a minimum of 50% [~125] patients diagnosed within 9 months prior to screening will be enrolled"}
  • {"criterion_text":"- Demonstrated response to prior anti-vascular endothelial growth factor (VEGF) intravitreal (IVT) treatment since diagnosis"}
  • {"criterion_text":"- nAMD disease stability detected per optical coherence tomography (OCT) at time of enrollment, as assessed by the investigator and confirmed by the central reading center (CRC)"}
  • {"criterion_text":"- Best-Corrected Visual Acuity (BCVA) of 34 letters or better (20/200 or better approximate Snellen equivalent),using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters (see the BCVA manual for additional details) at screening and enrollment visits"}
  • {"criterion_text":"- Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD"}

Exclusion criteria

  • {"criterion_text":"- History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)"}
  • {"criterion_text":"- Prior pars plana vitrectomy surgery"}
  • {"criterion_text":"- Prior treatment with Visudyne® (verteporfin for injection), external-beam radiation therapy, or transpupillary thermotherapy"}
  • {"criterion_text":"- The presence of subfoveal fibrosis or subfoveal atrophy in the study eye"}
  • {"criterion_text":"- Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the superotemporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant"}
  • {"criterion_text":"- Previous intraocular device implantation (not including intraocular lens implants)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline best-corrected visual acuity (BCVA) score as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters averaged over Weeks 68 and 72","definition_or_measurement_approach":"Measured using the ETDRS chart at a starting distance of 4 meters; change from baseline BCVA score averaged over Weeks 68 and 72"}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in BCVA score over time (up to and including Week 72)","definition_or_measurement_approach":"BCVA score change from baseline measured over time up to and including Week 72"}
  • {"endpoint_text":"- Proportion of patients who lose ≤ 15, ≤ 10, ≤ 5, or gain ≥ 0 letters in BCVA score from baseline over time up to and including Week 72","definition_or_measurement_approach":"Proportions of patients meeting specified letter-change thresholds in BCVA from baseline through Week 72"}
  • {"endpoint_text":"- Change from baseline in center point thickness (CPT) over time up to and including Week 72","definition_or_measurement_approach":"Change from baseline in OCT-derived center point thickness measured over time up to and including Week 72"}
  • {"endpoint_text":"- Change from baseline in central subfield thickness (CST) over time up to and including Week 72","definition_or_measurement_approach":"Change from baseline in OCT-derived central subfield thickness measured over time up to and including Week 72"}
  • {"endpoint_text":"- Proportion of participants who do not undergo supplemental treatment with IVT ranibizumab 0.5 mg before each refill-exchange procedure and overall up to and including Week 72","definition_or_measurement_approach":"Proportion of participants not receiving supplemental IVT ranibizumab 0.5 mg prior to each refill-exchange and overall through Week 72"}
  • {"endpoint_text":"- Number of supplemental treatments with IVT ranibizumab 0.5 mg patients received in each refill cycle and overall up to and including Week 72","definition_or_measurement_approach":"Count of supplemental IVT ranibizumab 0.5 mg treatments per refill cycle and cumulatively through Week 72"}
  • {"endpoint_text":"- Frequency of study visits in each refill cycle and overall up to and including Week 72","definition_or_measurement_approach":"Frequency (number/timing) of study visits recorded per refill cycle and overall through Week 72"}
  • {"endpoint_text":"- Proportion of patients who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with IVT treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Weeks 24 and 72","definition_or_measurement_approach":"Patient preference as measured by the PDS Patient Preference Questionnaire (PPPQ) at Weeks 24 and 72 comparing PDS-delivered ranibizumab 100 mg/mL versus IVT"}
  • {"endpoint_text":"- Proportion of patients with bilateral disease who report preferring PDS compared with IVT treatment, as measured by the PPPQ at Weeks 24 and 72","definition_or_measurement_approach":"Subgroup (bilateral disease) patient preference measured by PPPQ at Weeks 24 and 72"}
  • {"endpoint_text":"- Incidence and severity of ocular and systemic (non-ocular) adverse events","definition_or_measurement_approach":"Collection and grading of ocular and systemic adverse events; incidence and severity reported"}
  • {"endpoint_text":"- Incidence and severity of adverse events of special interest, including ocular adverse events of special interest","definition_or_measurement_approach":"Incidence and severity reporting for pre-specified adverse events of special interest, including ocular AESIs"}
  • {"endpoint_text":"- Incidence and severity of ocular adverse events of special interest during the postoperative period (≤ 37 days of initial implantation) and follow-up period ( > 37 days after implantation surgery)","definition_or_measurement_approach":"Incidence and severity of specified ocular AESIs stratified by postoperative period (≤37 days) and follow-up period (>37 days)"}
  • {"endpoint_text":"- Incidence and severity of adverse device effects with PDS","definition_or_measurement_approach":"Incidence and severity reporting of adverse device effects related to the Port Delivery System (PDS)"}
  • {"endpoint_text":"- Incidence, and severity of anticipated serious adverse device effects with PDS","definition_or_measurement_approach":"Incidence and severity reporting of anticipated serious adverse device effects associated with PDS"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
86
Recruitment Window Months
37
Consent Approach
Informed consent materials and subject information sheets are provided (multiple L1/L2/L3 ICF and SIS documents). There are dedicated caregiver ICFs, infant/newborn authorization forms and optional consent forms (e.g. optional aqueous humor collection, optional genotyping, imaging certification, RBR) indicating age-specific/role-specific consent/authorization pathways. Materials are available in multiple country/language-specific versions (examples in file names include EL-GR, CZ, PL, FR, IT, ES, DE), and caregiver/infant authorization forms indicate consent/authorization by caregivers or legal representatives where applicable.

Methods

  • Study brochures (country/language-specific versions), digital flyers and printed flyers
  • Patient invite letters (country/language-specific)
  • Posters (digital/printed) for clinic display
  • Patient information videos with QR codes (country-specific video QR codes included in materials)
  • Social media posts (documented 'Social Media Post' recruitment material)
  • Site-level recruitment arrangements documents (K1 recruitment arrangements) and investigator/site contact points

Geography

Total Number Of Sites
47
Total Number Of Participants
164

Austria

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
301
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
University Hospital for Ophthalmology and Optometry
Principal Investigator Name
Matus Rehak
Contact Person Name
Matus Rehak
Site Name
Johannes Kepler University Linz
Department Name
Department of Ophthalmology and Optometry
Principal Investigator Name
Matthias Bolz
Principal Investigator Email
aug.studienzentrum@kepleruniklinikum.at
Contact Person Name
Matthias Bolz
Site Name
NOE Landesgesundheitsagentur
Department Name
Department of Ophthalmology
Principal Investigator Name
Sebastian Waldstein
Principal Investigator Email
augenheilkunde@mistelbach.lknoe.at
Contact Person Name
Sebastian Waldstein

Greece

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
303
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Ophthalmology Clinic
Principal Investigator Name
Miltiadis K. Tsilimbaris
Principal Investigator Email
tsilimb@gmail.com
Contact Person Name
Miltiadis K. Tsilimbaris
Contact Person Email
tsilimb@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Department of Ophthalmology
Principal Investigator Name
Irini Chatziralli
Principal Investigator Email
eirchat@yahoo.gr
Contact Person Name
Irini Chatziralli
Contact Person Email
eirchat@yahoo.gr
Site Name
General Hospital Of Athens G Gennimatas
Department Name
First Ophthalmology Department
Principal Investigator Name
Ilias Georgalas
Principal Investigator Email
igeorgalas@yahoo.com
Contact Person Name
Ilias Georgalas
Contact Person Email
igeorgalas@yahoo.com
Site Name
General University Hospital Of Larissa
Department Name
Ophthalmology Clinic
Principal Investigator Name
Sofia Androudi
Principal Investigator Email
androudi@otenet.gr
Contact Person Name
Sofia Androudi
Contact Person Email
androudi@otenet.gr

Poland

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
243
Number Of Sites
11
Number Of Participants
34

Sites

Site Name
Oftalmika Sp. z o.o.
Department Name
Oftalmika
Principal Investigator Name
Jakub Kałużny
Principal Investigator Email
magda.d.marzec@oftalmika.pl
Contact Person Name
Jakub Kałużny
Contact Person Email
magda.d.marzec@oftalmika.pl
Site Name
Okręgowy Szpital Kolejowy w Katowicach SPZOZ
Department Name
Europejskie Centrum Okulistyki
Principal Investigator Name
Adam Wylęgała
Principal Investigator Email
cmwylegala@gmail.com
Contact Person Name
Adam Wylęgała
Contact Person Email
cmwylegala@gmail.com
Site Name
Pryzmat Sp. z o.o.
Department Name
NZOZ Pryzmat, Pryzmat-Mikrochirurgia Okulistyczna
Principal Investigator Name
Karolina Żaczek-Zakrzewska
Principal Investigator Email
biuro@pryzmat-okulistyka.pl
Contact Person Name
Karolina Żaczek-Zakrzewska
Contact Person Email
biuro@pryzmat-okulistyka.pl
Site Name
Oculomedica Sp. z o.o.
Department Name
Specjalistyczny Ośrodek Okulistyczny Oculomedica
Principal Investigator Name
Bartosz Sikorski
Principal Investigator Email
research@oculomedica.pl
Contact Person Name
Bartosz Sikorski
Contact Person Email
research@oculomedica.pl
Site Name
Gabinet Okulistyczny Prof Edward Wylegala
Department Name
Gabinet Okulistyczny prof. Edward Wylegala
Principal Investigator Name
Adam Wylęgała
Principal Investigator Email
cmwylegala@gmail.com
Contact Person Name
Adam Wylęgała
Contact Person Email
cmwylegala@gmail.com
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
b.kania@su.krakow.pl
Contact Person Name
Bożena Romanowska-Dixon
Contact Person Email
b.kania@su.krakow.pl
Site Name
Szpital Swietego Lukasza S.A.
Department Name
Oddział Okulistyczny
Principal Investigator Name
Bogumił Wowra
Principal Investigator Email
sekretariat@lukasza.pl
Contact Person Name
Bogumił Wowra
Contact Person Email
sekretariat@lukasza.pl
Site Name
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
Department Name
Centrum Diagnostyki i Mikrochirurgii Oka - Lens
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
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddział Chirurgii Siatkówki i Ciała Szklistego
Principal Investigator Name
Jerzy Mackiewicz
Principal Investigator Email
oks@usk1.pl
Contact Person Name
Jerzy Mackiewicz
Contact Person Email
oks@usk1.pl
Site Name
Klinika Okulistyczna Jasne Blonia Sp. z o.o.
Department Name
Klinika Okulistyczna Jasne Błonia
Principal Investigator Name
Zofia Nawrocka
Principal Investigator Email
wasikania@gmail.com
Contact Person Name
Zofia Nawrocka
Contact Person Email
wasikania@gmail.com
Site Name
Mw-Med Sp. z o.o.
Department Name
Mw-MED
Principal Investigator Name
Joanna Miniewicz
Principal Investigator Email
recepcja@mwmed.pl
Contact Person Name
Joanna Miniewicz
Contact Person Email
recepcja@mwmed.pl

Denmark

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
238
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Aarhus Universitet
Department Name
Øjensygdomme
Principal Investigator Name
Line Petersen
Principal Investigator Email
linperse@rm.dk
Contact Person Name
Line Petersen
Contact Person Email
linperse@rm.dk
Site Name
Rigshospitalet
Department Name
Øjensygdomme
Principal Investigator Name
Larsen Michael
Principal Investigator Email
lars.michael.larsen@regionh.dk
Contact Person Name
Larsen Michael
Contact Person Email
lars.michael.larsen@regionh.dk

France

Earliest CTIS Part Ii Submission Date
11-08-2025
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
219
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
Institut Ophtalmologique De l'Ouest Jules Verne
Department Name
Service Ophtalmologie
Principal Investigator Name
Frank Becquet
Principal Investigator Email
frankbecquet@yahoo.fr
Contact Person Name
Frank Becquet
Contact Person Email
frankbecquet@yahoo.fr
Site Name
Clinique Honore Cave
Department Name
Service Ophtalmologie
Principal Investigator Name
Vincent GUALINO
Principal Investigator Email
dr.vgualino@gmail.com
Contact Person Name
Vincent GUALINO
Contact Person Email
dr.vgualino@gmail.com
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service Ophtalmologie
Principal Investigator Name
David GAUCHER
Principal Investigator Email
david.gaucher@chru-strasbourg.fr
Contact Person Name
David GAUCHER
Site Name
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
Department Name
Ophtalmologie
Principal Investigator Name
Sarah AYELLO-SCHEER
Principal Investigator Email
sscheer@15-20.fr
Contact Person Name
Sarah AYELLO-SCHEER
Contact Person Email
sscheer@15-20.fr
Site Name
Hospital Edouard Herriot
Department Name
Service Ophtalmologie
Principal Investigator Name
Corinne DOT
Principal Investigator Email
corinne.dot@chu-lyon.fr
Contact Person Name
Corinne DOT
Contact Person Email
corinne.dot@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service Ophtalmologie
Principal Investigator Name
Nicolas LEVEZIEL
Principal Investigator Email
nicolas.leveziel@chu-poitiers.fr
Contact Person Name
Nicolas LEVEZIEL

Germany

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
230
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Augenklinik und Poliklinik
Principal Investigator Name
Andreas Berlin
Principal Investigator Email
augenklinik@ukw.de
Contact Person Name
Andreas Berlin
Contact Person Email
augenklinik@ukw.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Universitäts-Augenklinik
Principal Investigator Name
Rainer Guthoff
Principal Investigator Email
amublanz.augen@med.uni-duesseldorf.de
Contact Person Name
Rainer Guthoff
Site Name
Universitaetsmedizin Goettingen
Department Name
Augenheilkunde
Principal Investigator Name
Sebastian Bemme
Principal Investigator Email
augenklinik@med.uni-goettingen.de
Contact Person Name
Sebastian Bemme
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Jan Tode
Principal Investigator Email
augenklinik.sekretariat@mh-hannover.de
Contact Person Name
Jan Tode
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Vinodh Kakkassery
Principal Investigator Email
augenklinik@skc.de
Contact Person Name
Vinodh Kakkassery
Contact Person Email
augenklinik@skc.de
Site Name
Rostock University Medical Center
Department Name
Klinik und Poliklinik für Augenheilkunde
Principal Investigator Name
Friederike Schaub
Principal Investigator Email
friederike.schaub@med.uni-rostock.d
Contact Person Name
Friederike Schaub

Italy

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
246
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
University Hospital Of Ferrara
Department Name
Medicina traslazionale
Principal Investigator Name
Marco Mura
Principal Investigator Email
dmtr@unife.it
Contact Person Name
Marco Mura
Contact Person Email
dmtr@unife.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
UOC Oculistica
Principal Investigator Name
Michele Reibaldi
Principal Investigator Email
michele.reibaldi@unito.it
Contact Person Name
Michele Reibaldi
Contact Person Email
michele.reibaldi@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Oftalmologia
Principal Investigator Name
Giovanni Esposito
Principal Investigator Email
giovanni.esposito@asst-santipaolocarlo.it
Contact Person Name
Giovanni Esposito
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Oftalmologia
Principal Investigator Name
Stefano De Cillà
Principal Investigator Email
stefano.decilla@maggioreosp.novara.it
Contact Person Name
Stefano De Cillà
Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
Vitroretinal surgery unit
Principal Investigator Name
Tomaso Caporossi
Principal Investigator Email
tomaso.caporossi@fbf-isola.it
Contact Person Name
Tomaso Caporossi
Contact Person Email
tomaso.caporossi@fbf-isola.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Oftalmologia
Principal Investigator Name
Flavia Chiosi
Principal Investigator Email
flavia.chiosi@ospedaledeicolli.it
Contact Person Name
Flavia Chiosi
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Oculistica
Principal Investigator Name
Vincenza Bonfiglio
Principal Investigator Email
vincenzamariaelena.bonfiglio@unipa.it
Contact Person Name
Vincenza Bonfiglio

Spain

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
232
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Ophthalmology
Principal Investigator Name
Mariano Rodriguez Maqueda
Principal Investigator Email
mrodriguezmaqueda@gmail.com
Contact Person Name
Mariano Rodriguez Maqueda
Contact Person Email
mrodriguezmaqueda@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Ophthalmology
Principal Investigator Name
Raquel Castro Florez
Principal Investigator Email
raquel.castro@quironsalud.es
Contact Person Name
Raquel Castro Florez
Contact Person Email
raquel.castro@quironsalud.es
Site Name
Hospital Universitario La Paz
Department Name
Ophthalmology
Principal Investigator Name
Félix Armadá-Maresca
Principal Investigator Email
felixarmada65@gmail.com
Contact Person Name
Félix Armadá-Maresca
Contact Person Email
felixarmada65@gmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
Ophthalmology
Principal Investigator Name
Enrique Lopez Sanchez
Principal Investigator Email
oftalmolopez@gmail.com
Contact Person Name
Enrique Lopez Sanchez
Contact Person Email
oftalmolopez@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
21-07-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
241
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Oftalmologická klinika
Principal Investigator Name
Miroslav Veith
Principal Investigator Email
mveith@email.cz
Contact Person Name
Miroslav Veith
Contact Person Email
mveith@email.cz
Site Name
Oblastni nemocnice Mlada Boleslav a.s. nemocnice Stredoceskeho kraje
Department Name
Oční oddělení
Principal Investigator Name
Alexandr Stěpanov
Principal Investigator Email
stepanov.doctor@gmail.com
Contact Person Name
Alexandr Stěpanov
Contact Person Email
stepanov.doctor@gmail.com
Site Name
Fakultni Nemocnice Ostrava
Department Name
Oční
Principal Investigator Name
Jan Němčanský
Principal Investigator Email
jan.nemcansky@fno.cz
Contact Person Name
Jan Němčanský
Contact Person Email
jan.nemcansky@fno.cz
Site Name
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Department Name
Oční klinika
Principal Investigator Name
Martin Šín
Principal Investigator Email
sin.martin@uvn.cz
Contact Person Name
Martin Šín
Contact Person Email
sin.martin@uvn.cz

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Sponsor duty code: 6
Name
IQVIA Limited
Responsibilities
Monitoring FSP
Name
Pharmaceutical Product Development LLC
Responsibilities
BioanalyticalQAManagement
Name
PPD Development LP
Responsibilities
Medical Monitoring Provider
Name
Drugdev Inc.
Responsibilities
Investigator Study Portal

Third parties

  • {"country":"Germany","full_name":"Steinbeis-Forschungszentrum Grade Reading Center","duties_or_roles":"Central Imaging Provider: GRADE Reading Center","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"Topcon Europe Medical B.V.","duties_or_roles":"Supplier of Imaging Equipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Sponsor duty code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Avalere Health GmbH","duties_or_roles":"Branding, communications, Investigator Meeting & Steering Committee content","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cenetron Diagnostics Ltd.","duties_or_roles":"Supply of ancillary Supplies (Surgical supplies etc.)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"IMs and Surgical Training Meetings","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Xogene Services LLC","duties_or_roles":"Sponsor duty code: 11","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Investigator Study Portal","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Prism Ideas Limited","duties_or_roles":"Sponsor duty code: 11","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring FSP","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Chillibean Limited","duties_or_roles":"Video Repository","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"BioanalyticalQAManagement","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Medical Monitoring Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Heidelberg Engineering GmbH","duties_or_roles":"Supplier of Imaging Equipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sponsor duty code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO4893594
Active Substance
ranibizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVITREAL USE
Route
INTRAVITREAL USE
Authorisation Status
Investigational (no marketing authorisation listed in record)
Maximum Dose
maxDailyDoseAmount 2 mg; maxTotalDoseAmount 8 mg
Investigational Product Name
Lucentis 10 mg/ml solution for injection in pre-filled syringe
Active Substance
ranibizumab
Modality
Monoclonal antibody
Routes Of Administration
IMPLANTATION
Route
IMPLANTATION
Authorisation Status
Authorised (marketing authorisation EU/1/06/374/003)
Maximum Dose
maxDailyDoseAmount 2 mg; maxTotalDoseAmount 12 mg
Combination Treatment
Yes

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