Clinical trial • Phase III • Ophthalmology

ranibizumab for Neovascular age-related macular degeneration

Phase III trial of ranibizumab for Neovascular age-related macular degeneration. open-label, none/not specified-controlled. 666 participants.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Neovascular age-related macular degeneration
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
15-07-2024
First CTIS Authorization Date
08-08-2024

Trial design

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

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
666

Eligibility

Recruits 666 paediatric patients.

Pregnancy Exclusion
Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 3 months after the final intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
Vulnerable Population
The CTIS record indicates 'isVulnerablePopulationSelected': true and documents include child-specific informed consent materials (e.g. "L1_SIS and ICF_ Data collection child"). Subject information and informed consent forms for adults and child-specific documents are present in multiple languages (see documents list). The record does not explicitly state the exact consent/assent signature process or who provides consent for minors in the JSON metadata.

Inclusion criteria

  • {"criterion_text":"- Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study (monthly intravitreal ranibizumab 0.5 mg or implant arms) OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)\n- Ability and willingness to undertake all scheduled visits and assessments\n- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during the treatment period and for at least 3 months after the last intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab"}

Exclusion criteria

  • {"criterion_text":"- Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 3 months after the final intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab\n- History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications\n- History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications\n- Requirement for continuous use of any medications or treatments indicated in the \"Prohibited Therapy\""}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Incidence and severity of ocular and systemic (non-ocular) adverse events","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2. Incidence, severity, and duration of adverse event of special interest (AESIs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3. Incidence, severity, and duration of ocular AESIs during the post operative period (up to 37 days of initial implantation) and follow up period (>37 days after implantation surgery) for patients who receive the implant in the study","definition_or_measurement_approach":"Measurement window specified: postoperative period up to 37 days after initial implantation and follow-up period >37 days after implantation surgery for implant recipients."}
  • {"endpoint_text":"- 4. Incidence and severity of adverse device effects","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 5. Incidence, causality, severity, and duration of anticipated serious adverse device effects","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. Change in best-corrected visual acuity (BCVA) score from baseline over time, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters","definition_or_measurement_approach":"BCVA measured using ETDRS visual acuity chart at a starting distance of 4 meters."}
  • {"endpoint_text":"- 2. Percentage of patients who lose < 15, < 10, or < 5 letters in BCVA score from baseline over time","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3. Percentage of patients with BCVA score of 38 letters (of 20/200 approximate Snellen equivalent) or worse over time","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 4. Percentage of patients with BCVA score of 69 letters (20/40 approximate Snellen equivalent) or better over time","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 5. Change from baseline in CPT over time","definition_or_measurement_approach":"CPT measured by optical coherence tomography (OCT)."}
  • {"endpoint_text":"- 6. Percentage of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg during each refill-exchange interval","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
666
Recruitment Window Months
88
Consent Approach
Subject information and informed consent forms (SIS and ICF) are provided and available in multiple languages as shown in the documents list (examples include English, French, Dutch, German, Italian, Spanish). Child-specific informed consent/data-collection documents are present (e.g. 'L1_SIS and ICF_ Data collection child'), indicating procedures for minors are documented; the CTIS metadata does not provide the explicit text of who signs consent/assent in the JSON.

Geography

Total Number Of Sites
61
Total Number Of Participants
191

Belgium

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
08-07-2025
Processing Time Days
344
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
UZ Leuven
Department Name
Ophthalmology
Principal Investigator Name
Julie Jacob
Principal Investigator Email
julie.jacob@uzleuven.be
Contact Person Name
Julie Jacob
Contact Person Email
julie.jacob@uzleuven.be

Germany

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
20-06-2025
Processing Time Days
325
Number Of Sites
15
Number Of Participants
51

Sites

Site Name
Universitaet Muenster
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Nicole Eter
Principal Investigator Email
augenklinik@ukmuenster.de
Contact Person Name
Nicole Eter
Contact Person Email
augenklinik@ukmuenster.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Augenheilkunde
Principal Investigator Name
Andreea Gamulescu
Principal Investigator Email
andreea.gamulescu@ukr.de
Contact Person Name
Andreea Gamulescu
Contact Person Email
andreea.gamulescu@ukr.de
Site Name
Augenzentrum Prof. Dr. Koch GmbH
Department Name
Augenzentrum
Principal Investigator Name
Svenja Deuchler
Principal Investigator Email
info@augenzentrumfrankfurt.de
Contact Person Name
Svenja Deuchler
Contact Person Email
info@augenzentrumfrankfurt.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Frank Holz
Principal Investigator Email
augenklinik@ukbonn.de
Contact Person Name
Frank Holz
Contact Person Email
augenklinik@ukbonn.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Augenheilkunde
Principal Investigator Name
Spyridon Dimopoulos
Principal Investigator Email
team@stz-eyetrial.de
Contact Person Name
Spyridon Dimopoulos
Contact Person Email
team@stz-eyetrial.de
Site Name
University Hospital Cologne AöR
Department Name
Augenklinik
Principal Investigator Name
Tim Krohne
Principal Investigator Email
augenklinik-studien@uk-koeln.de
Contact Person Name
Tim Krohne
Site Name
Knappschaftsklinikum Saar GmbH
Department Name
Augenklinik
Principal Investigator Name
Boris Stanzel
Principal Investigator Email
augenklinik@kksaar.de
Contact Person Name
Boris Stanzel
Contact Person Email
augenklinik@kksaar.de
Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
Augenklinik
Principal Investigator Name
Lars-Olof Hattenbach
Principal Investigator Email
info@klilu.de
Contact Person Name
Lars-Olof Hattenbach
Contact Person Email
info@klilu.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Augenheilkunde
Principal Investigator Name
Martin Spitzer
Principal Investigator Email
augenklinik@uke.de
Contact Person Name
Martin Spitzer
Contact Person Email
augenklinik@uke.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Hansjürgen Agostini
Principal Investigator Email
hansjuergen.agostini@uniklinik-freiburg.de
Contact Person Name
Hansjürgen Agostini
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Helmut Sachs
Principal Investigator Email
info@ctk.de
Contact Person Name
Helmut Sachs
Contact Person Email
info@ctk.de
Site Name
Augenzentrum Am St Franziskus-Hospital Muenster
Department Name
Augenabteilung
Principal Investigator Name
Albrecht Peter Lommatzsch
Principal Investigator Email
terminvereinbarung@augen-franziskus.de
Contact Person Name
Albrecht Peter Lommatzsch
Site Name
Ludwig-Maximilians-Universitaet Muenchen
Department Name
Augenklinik
Principal Investigator Name
Siegfried Priglinger
Principal Investigator Email
augenklinik@med.uni-muenchen.de
Contact Person Name
Siegfried Priglinger
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Armin Wolf
Principal Investigator Email
sekretariat.augenklinik@uniklinik-ulm.de
Contact Person Name
Armin Wolf
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Augenklinik
Principal Investigator Name
Victor A. Augustin
Principal Investigator Email
Victor.Augustin@med.uni-heidelberg.de
Contact Person Name
Victor A. Augustin

Austria

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
323
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Medical University Of Graz
Department Name
Department of Ophthalmology
Principal Investigator Name
Anton Haas
Principal Investigator Email
eye-studies@medunigraz.at
Contact Person Name
Anton Haas
Contact Person Email
eye-studies@medunigraz.at
Site Name
Medical University Of Vienna
Department Name
Department of Ophthalmology and Optometry
Principal Investigator Name
Stefan Sacu
Principal Investigator Email
eye-studies@meduniwien.ac.at
Contact Person Name
Stefan Sacu
Contact Person Email
eye-studies@meduniwien.ac.at

France

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
20-06-2025
Processing Time Days
325
Number Of Sites
11
Number Of Participants
40

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Avicenne; Ophtalmologie
Principal Investigator Name
Franck Fajnkuchen
Principal Investigator Email
Franck.fajnkuchen@aphp.fr
Contact Person Name
Franck Fajnkuchen
Contact Person Email
Franck.fajnkuchen@aphp.fr
Site Name
Selarl Retine Tourny
Department Name
Centre Rétine Gallien
Principal Investigator Name
Laurent Vélasque
Principal Investigator Email
l.velasque@hotmail.fr
Contact Person Name
Laurent Vélasque
Contact Person Email
l.velasque@hotmail.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hôpital PURPAN - Ophtalmologie
Principal Investigator Name
Vincent Soler
Principal Investigator Email
soler.v@chu-toulouse.fr
Contact Person Name
Vincent Soler
Contact Person Email
soler.v@chu-toulouse.fr
Site Name
Fondation A De Rothschild
Department Name
Fondation Rothschild; Ophtalmologie
Principal Investigator Name
Yannick Le Mer
Principal Investigator Email
ylemer@for.paris
Contact Person Name
Yannick Le Mer
Contact Person Email
ylemer@for.paris
Site Name
Hospital Hotel Dieu
Department Name
Hôpital Hôtel Dieu; Ophthalmology
Principal Investigator Name
Hélène Masse
Principal Investigator Email
helene.masse@chu-nantes.fr
Contact Person Name
Hélène Masse
Contact Person Email
helene.masse@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hôpital Pasteur ; Ophtalmologie
Principal Investigator Name
Stephanie Baillif
Principal Investigator Email
baillif.s@chu-nice.fr
Contact Person Name
Stephanie Baillif
Contact Person Email
baillif.s@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
CHU Bocage; Ophtalmologie
Principal Investigator Name
Catherine Creuzot Garcher
Principal Investigator Email
catherine.creuzot-recherche@chu-dijon.fr
Contact Person Name
Catherine Creuzot Garcher
Site Name
Hopital De La Croix-Rousse
Department Name
Hopital de la croix rousse; Ophtalmologie
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
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Lariboisiere; Ophtalmologie
Principal Investigator Name
Aude Couturier
Principal Investigator Email
aude.couturier@aphp.fr
Contact Person Name
Aude Couturier
Contact Person Email
aude.couturier@aphp.fr
Site Name
Clinique Mathilde
Department Name
Clinique Mathilde; Ophtalmologie
Principal Investigator Name
Joel Uzzan
Principal Investigator Email
Ophtalmo@uzzan.net
Contact Person Name
Joel Uzzan
Contact Person Email
Ophtalmo@uzzan.net
Site Name
Centre Monticelli Paradis D Ophtalmologie
Department Name
Centre Paradis Monticelli; Ophtalmologie
Principal Investigator Name
François Devin
Principal Investigator Email
fdbm.retine@gmail.com
Contact Person Name
François Devin
Contact Person Email
fdbm.retine@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
421
Number Of Sites
17
Number Of Participants
40

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Ophtalmology
Principal Investigator Name
Alfredo García-Layana
Principal Investigator Email
aglayana@unav.es
Contact Person Name
Alfredo García-Layana
Contact Person Email
aglayana@unav.es
Site Name
Centro Medico Teknon-Grupo Quironsalud
Department Name
Ophtalmology
Principal Investigator Name
Juan Francisco Santamaría Álvarez
Principal Investigator Email
jsantamaria@institutmacula.com
Contact Person Name
Juan Francisco Santamaría Álvarez
Contact Person Email
jsantamaria@institutmacula.com
Site Name
Instituto Oftalmologico Fernandez-Vega S.L.
Department Name
Ophtalmology
Principal Investigator Name
Álvaro Fernandez-Vega Sanz
Principal Investigator Email
investigacion@fernandez-vega.com
Contact Person Name
Álvaro Fernandez-Vega Sanz
Site Name
Hospital Universitario Rio Hortega
Department Name
Ophtalmology
Principal Investigator Name
Jaime Montero Moreno
Principal Investigator Email
jamonterom@saludcastillayleon.es
Contact Person Name
Jaime Montero Moreno
Site Name
Hospital Universitari Vall D Hebron
Department Name
Ophtalmology
Principal Investigator Name
Jose Garcia Arumi
Principal Investigator Email
jgarcia.arumi@gmail.com
Contact Person Name
Jose Garcia Arumi
Contact Person Email
jgarcia.arumi@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Ophtalmology
Principal Investigator Name
Jose María Ruiz Moreno
Principal Investigator Email
JoseMaria.Ruiz@uclm.es
Contact Person Name
Jose María Ruiz Moreno
Contact Person Email
JoseMaria.Ruiz@uclm.es
Site Name
Oftalmologia Vistahermosa S.L.
Department Name
Ophtalmology
Principal Investigator Name
Rosa Dolz Marco
Principal Investigator Email
rdolz@oftalvist.es
Contact Person Name
Rosa Dolz Marco
Contact Person Email
rdolz@oftalvist.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Ophtalmology
Principal Investigator Name
Francisco Espejo Arjona
Principal Investigator Email
dr.franciscoespejo@gmail.com
Contact Person Name
Francisco Espejo Arjona
Contact Person Email
dr.franciscoespejo@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Ophtalmology
Principal Investigator Name
Alfredo García-Layana
Principal Investigator Email
aglayana@unav.es
Contact Person Name
Alfredo García-Layana
Contact Person Email
aglayana@unav.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Ophtalmology
Principal Investigator Name
Patricia Udaondo Mirete
Principal Investigator Email
Patyudaondo@hotmail.com
Contact Person Name
Patricia Udaondo Mirete
Contact Person Email
Patyudaondo@hotmail.com
Site Name
Clinica De Oftalmologia De Cordoba S.L.
Department Name
Ophtalmology
Principal Investigator Name
Juan Manuel Cubero Parra
Principal Investigator Email
jmcubero@hospitalarruzafa.com
Contact Person Name
Juan Manuel Cubero Parra
Contact Person Email
jmcubero@hospitalarruzafa.com
Site Name
Clinica Baviera S.A.
Department Name
Ophtalmology
Principal Investigator Name
Marta S. Figueroa
Principal Investigator Email
Figueroa.Marta@outlook.es
Contact Person Name
Marta S. Figueroa
Contact Person Email
Figueroa.Marta@outlook.es
Site Name
Bellvitge University Hospital
Department Name
Ophtalmology
Principal Investigator Name
Luis Arias Barquet
Principal Investigator Email
luisariasbarquet@gmail.com
Contact Person Name
Luis Arias Barquet
Contact Person Email
luisariasbarquet@gmail.com
Site Name
Centro De Oftalmologia Barraquer S.A.
Department Name
Ophtalmology
Principal Investigator Name
Santiago Abengoechea Hernandez
Principal Investigator Email
victoria.hernandez@barraquer.com
Contact Person Name
Santiago Abengoechea Hernandez
Site Name
Hospital Universitari General De Catalunya
Department Name
Ophtalmology
Principal Investigator Name
Laura Sararols Ramsay
Principal Investigator Email
lsararols@omiq.es
Contact Person Name
Laura Sararols Ramsay
Contact Person Email
lsararols@omiq.es
Site Name
Hospital Clinic De Barcelona
Department Name
Ophtalmology
Principal Investigator Name
Alfredo Adan Civera
Principal Investigator Email
amadan@clinic.cat
Contact Person Name
Alfredo Adan Civera
Contact Person Email
amadan@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Ophtalmology
Principal Investigator Name
Lorenzo López Guajardo
Principal Investigator Email
lorenzo.lopez@salud.madrid.org
Contact Person Name
Lorenzo López Guajardo
Contact Person Email
lorenzo.lopez@salud.madrid.org

Italy

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
571
Number Of Sites
15
Number Of Participants
44

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oftalmologia
Principal Investigator Name
Angelo Maria Minnella
Principal Investigator Email
angelomaria.minnella@unicatt.it
Contact Person Name
Angelo Maria Minnella
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oculistica
Principal Investigator Name
Francesco Bandello
Principal Investigator Email
bandello.francesco@hsr.it
Contact Person Name
Francesco Bandello
Contact Person Email
bandello.francesco@hsr.it
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
Clinica Oftalmologica
Principal Investigator Name
Leonardo Mastropasqua
Principal Investigator Email
leonardo.mastropasqua@unich.it
Contact Person Name
Leonardo Mastropasqua
Contact Person Email
leonardo.mastropasqua@unich.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Oculistica
Principal Investigator Name
Lupidi Marco
Principal Investigator Email
marco.lupidi@ospedaliriuniti.marche.it
Contact Person Name
Lupidi Marco
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Clinica Oculistica Udine
Principal Investigator Name
Lanzetta Paolo
Principal Investigator Email
paolo.lanzetta@uniud.it
Contact Person Name
Lanzetta Paolo
Contact Person Email
paolo.lanzetta@uniud.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Clinica Oculistica
Principal Investigator Name
Carlo Cagini
Principal Investigator Email
carlo.cagini@unipg.it
Contact Person Name
Carlo Cagini
Contact Person Email
carlo.cagini@unipg.it
Site Name
Careggi University Hospital
Department Name
Oculistica
Principal Investigator Name
Fabrizio Giansanti
Principal Investigator Email
fabrizio.giansanti@unifi.it
Contact Person Name
Fabrizio Giansanti
Contact Person Email
fabrizio.giansanti@unifi.it
Site Name
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
UR Retina Medica
Principal Investigator Name
Mariacristina Parravano
Contact Person Name
Mariacristina Parravano
Site Name
Azienda Ospedaliero - Universitaria Consorziale Policlinico
Department Name
Oculistica
Principal Investigator Name
Francesco Boscia
Principal Investigator Email
francescoboscia@hotmail.com
Contact Person Name
Francesco Boscia
Contact Person Email
francescoboscia@hotmail.com
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Oculistica
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
Cliniche Gavazzeni S.p.A.
Department Name
Centro Oculistico
Principal Investigator Name
Mario Romano
Principal Investigator Email
Mario.romano.md@gmail.com
Contact Person Name
Mario Romano
Contact Person Email
Mario.romano.md@gmail.com
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC (UCO) Clinica oculistica
Principal Investigator Name
Daniele Tognetto
Principal Investigator Email
tognetto@units.it
Contact Person Name
Daniele Tognetto
Contact Person Email
tognetto@units.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Oculistica
Principal Investigator Name
Francesco Viola
Principal Investigator Email
francesco.viola@policlinico.mi.it
Contact Person Name
Francesco Viola
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oculistica
Principal Investigator Name
Reibaldi Michele
Principal Investigator Email
michele.reibaldi@unito.it
Contact Person Name
Reibaldi Michele
Contact Person Email
michele.reibaldi@unito.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Oculistica
Principal Investigator Name
Giovanni Staurenghi
Principal Investigator Email
giovanni.sturenghi@unimi.it
Contact Person Name
Giovanni Staurenghi
Contact Person Email
giovanni.sturenghi@unimi.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
Monitoring
Name
Icon Clinical Research Limited
Responsibilities
Safety reporting
Name
Pharmaceutical Product Development LLC
Responsibilities
PK samples

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC provider","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Payment System","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Chillibean Limited","duties_or_roles":"Surgical Video Scrubbing and Repository","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Safety reporting","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cenetron Diagnostics Ltd.","duties_or_roles":"Ancillary Surgical Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Steinbeis-Forschungszentrum Grade Reading Center","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
RO4893594
Active Substance
ranibizumab
Modality
Monoclonal antibody
Routes Of Administration
IMPLANTATION
Route
Implantation
Authorisation Status
prodAuthStatus: 1
Maximum Dose
12 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
prodAuthStatus: 2; marketing authorisation EU/1/06/374/003
Maximum Dose
12 mg
Combination Treatment
Yes

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