Clinical trial • Phase III • Ophthalmology

RANIBIZUMAB for Neovascular age-related macular degeneration

Phase III trial of RANIBIZUMAB for Neovascular age-related macular degeneration.

Overview

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

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
15-07-2024

Trial design

Randomised, open-label, port delivery system with ranibizumab 100 mg/ml every 36 weeks (q36w) versus port delivery system with ranibizumab 100 mg/ml every 24 weeks (q24w) (refill regimen comparison).-controlled Phase III trial across 63 sites in Belgium, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Port Delivery System with ranibizumab 100 mg/mL every 36 weeks (Q36W) versus Port Delivery System with ranibizumab 100 mg/mL every 24 weeks (Q24W) (refill regimen comparison).
Target Sample Size
259
Trial Duration For Participant
504

Eligibility

Recruits 259 The trial record indicates isVulnerablePopulationSelected: true; specific consent/assent handling details are not specified in the available CTIS data, though dedicated ICF documents (e.g. pregnancy, child born, caregiver information brochures) are listed in the study documents..

Vulnerable Population
The trial record indicates isVulnerablePopulationSelected: true; specific consent/assent handling details are not specified in the available CTIS data, though dedicated ICF documents (e.g. pregnancy, child born, caregiver information brochures) are listed in the study documents.

Inclusion criteria

  • {"criterion_text":"- Ocular inclusion criteria: Initial diagnosis nAMD within 9 months prior to the screening visit\n- Ocular inclusion criteria: Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit\n- Ocular inclusion criteria: Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment\n- Ocular inclusion criteria: BCVA of 34 letters or better, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment visits\n- Ocular inclusion criteria: With any subtype of nAMD lesions -\t nAMD lesions at the time of diagnosis must involve the macula (6-mm diameter centered at the fovea)\n- Ocular inclusion criteria: Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography, fluorescein angiography, fundus autofluorescence image, and OCT images"}

Exclusion criteria

  • {"criterion_text":"- Prior Ocular Treatment: Study Eye History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD\n- Prior Ocular Treatment: Either Eye Prior participation in a clinical trial involving any therapies for nAMD, within 9 months from the time of nAMD diagnosis\n- CNV Lesion Characteristics: Study Eye Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area in size at screening\n- Concurrent Systemic Conditions: Uncontrolled blood pressure\n- Concurrent Systemic Conditions: Use of any systemic anti-VEGF agents\n- Concurrent Systemic Conditions: Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in BCVA score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters","definition_or_measurement_approach":"Assessed using the ETDRS chart starting at a distance of 4 meters; change from baseline 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":"Change from baseline in BCVA score measured over time up to Week 72 using ETDRS"}
  • {"endpoint_text":"- Proportion of patients with BCVA score of 69 letters or better averaged over Weeks 68 and 72","definition_or_measurement_approach":"Proportion achieving BCVA ≥69 letters averaged over Weeks 68 and 72"}
  • {"endpoint_text":"- Proportion of patients with BCVA score of 69 letters or better over time","definition_or_measurement_approach":"Proportion achieving BCVA ≥69 letters measured over time"}
  • {"endpoint_text":"- Proportion of patients with BCVA score of 38 letters or worse averaged over Weeks 68 and 72","definition_or_measurement_approach":"Proportion with BCVA ≤38 letters averaged over Weeks 68 and 72"}
  • {"endpoint_text":"- Proportion of patients with BCVA score of 38 letters or worse over time","definition_or_measurement_approach":"Proportion with BCVA ≤38 letters measured over time"}
  • {"endpoint_text":"- Proportion of patients who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS PPPQ at Weeks 24, 40 and 72","definition_or_measurement_approach":"Patient preference measured by the PDS PPPQ at Weeks 24, 40 and 72"}
  • {"endpoint_text":"- Proportion of patients with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at Weeks 24, 40 and 72","definition_or_measurement_approach":"Patient preference for bilateral disease measured by PPPQ at Weeks 24, 40 and 72"}
  • {"endpoint_text":"- Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) total score in the Q36W arm compared with the Q24W arm","definition_or_measurement_approach":"MacTSQ total score at Week 40 comparing Q36W vs Q24W arms"}
  • {"endpoint_text":"- Proportion of patients who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72","definition_or_measurement_approach":"Proportions of patients with specified BCVA letter changes averaged over Weeks 68 and 72"}
  • {"endpoint_text":"- Proportion of patients who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time","definition_or_measurement_approach":"Proportions of patients with specified BCVA letter changes measured over time"}
  • {"endpoint_text":"- Change from baseline in CPT up to and including Week 72","definition_or_measurement_approach":"Change from baseline in center point thickness (CPT) measured up to Week 72 (OCT)"}
  • {"endpoint_text":"- Change from baseline in CST over time, up to and including Week 72","definition_or_measurement_approach":"Change from baseline in central subfield thickness (CST) over time up to Week 72 (OCT)"}
  • {"endpoint_text":"- Proportion of patients who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure","definition_or_measurement_approach":"Proportion not receiving supplemental intravitreal ranibizumab 0.5 mg prior to each refill-exchange"}
  • {"endpoint_text":"- Incidence and severity of ocular and systemic adverse events in Q36W compared with Q24W","definition_or_measurement_approach":"Incidence and severity of ocular and systemic AEs compared between arms"}
  • {"endpoint_text":"- Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W compared with Q24W","definition_or_measurement_approach":"Incidence, severity and duration of predefined AEs of special interest compared between arms"}
  • {"endpoint_text":"- Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period and follow-up period in all enrolled patients","definition_or_measurement_approach":"Postoperative and follow-up incidence, severity and duration of ocular AEs of special interest"}
  • {"endpoint_text":"- Incidence and severity of adverse device effects in the Q36W and Q24W arms","definition_or_measurement_approach":"Incidence and severity of adverse device effects compared across arms"}
  • {"endpoint_text":"- Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms","definition_or_measurement_approach":"Assessment of anticipated serious adverse device effects including causality, severity and duration"}
  • {"endpoint_text":"- Observed serum concentration of ranibizumab at specified timepoints","definition_or_measurement_approach":"Measured serum concentrations of ranibizumab at predefined timepoints (PK)"}
  • {"endpoint_text":"- Incidence of treatment-emergent ADAs to ranibizumab during the study","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies during the study"}

Recruitment

Digital Remote Recruitment
True, digital methods include a Study Information Animation and Patient Information Video (storyboard and artwork) available in multiple languages (EN/FR/NL) and other digital assets for outreach.
Planned Sample Size
259
Recruitment Window Months
57
Consent Approach
Informed consent documented via dedicated ICF materials; subject information and informed consent forms are available in English, French and Dutch (multiple ICF documents listed, including main ICF, RBR ICF, imaging certification ICF, pregnancy and child-born related ICFs, re-entry/explantation ICFs and caregiver information). The CTIS record lists specific ICF documents for imaging, re-entry, pregnancy and child-born matters and caregiver materials; explicit text describing who provides consent or assent is not available in the CTIS metadata but language- and topic-specific consent documents are provided.

Methods

  • Study poster (K2_Advertising material_Study_Poster) — patient-facing printed/digital poster materials (EN/FR/NL versions present)
  • Study flyer (K2_Advertising material_Study_Flyer) — patient-facing flyer (EN/FR/NL)
  • Patient brochure (K2_Advertising material_Patient_Brochure) — informational brochure for potential participants (EN/FR/NL)
  • Patient invite letter / Patient referral letter — direct mail/clinic referral letters to potential participants (EN/FR/NL)
  • Caregiver information brochure — materials targeted at caregivers
  • Study information animation / Patient information video (Study Information Animation, storyboard and artwork) — digital/animated content for remote information delivery (EN/FR/NL versions present)
  • Informed consent flipchart (K2_Advertising material_Informed_Consent_Flipchart) — on-site consent support tool (EN/FR/NL)
  • Appointment card / Takeaway consent booklet / Referral factcard — printed materials to support recruitment and retention

Geography

Total Number Of Sites
63
Total Number Of Participants
183

Belgium

Earliest CTIS Part Ii Submission Date
23-04-2024
Latest Decision Or Authorization Date
10-02-2025
Processing Time Days
293
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Chu Brugmann
Department Name
Ophthalmology
Contact Person Name
Laurence Postelmans
Site Name
UZ Leuven
Department Name
Ophthalmology
Contact Person Name
Julie Jacob
Contact Person Email
julie.jacob@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Ophthalmology
Contact Person Name
Julie De Zaeytijd
Contact Person Email
poli.oogziekten@uzgent.be

France

Earliest CTIS Part Ii Submission Date
14-07-2023
Latest Decision Or Authorization Date
25-07-2024
Processing Time Days
376
Number Of Sites
10
Number Of Participants
32

Sites

Site Name
Hopital De La Croix-Rousse
Department Name
Hopital de la croix rousse; Ophtalmologie
Contact Person Name
Laurent Kodjikian
Contact Person Email
laurent.kodjikian@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
CHU Bocage; Ophtalmologie
Contact Person Name
Catherine Creuzot Garcher
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hôpital Pasteur ; Ophtalmologie
Contact Person Name
Stephanie Baillif
Contact Person Email
baillif.s@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hôpital Hôtel Dieu; Ophthalmology
Contact Person Name
Hélène Masse
Contact Person Email
helene.masse@chu-nantes.fr
Site Name
Centre Monticelli Paradis D Ophtalmologie
Department Name
Centre Paradis Monticelli; Ophtalmologie
Contact Person Name
François Devin
Contact Person Email
fdbm.retine@gmail.com
Site Name
Selarl Retine Tourny
Department Name
Centre Rétine Gallien
Contact Person Name
Laurent Vélasque
Contact Person Email
l.velasque@hotmail.fr
Site Name
Fondation A De Rothschild
Department Name
Fondation Rothschild; Ophtalmologie
Contact Person Name
Yannick Le Mer
Contact Person Email
ylemer@for.paris
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hôpital PURPAN - Ophtalmologie
Contact Person Name
Vincent Soler
Contact Person Email
soler.v@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Lariboisiere; Ophtalmologie
Contact Person Name
Aude Couturier
Contact Person Email
aude.couturier@aphp.fr
Site Name
Hopital De La Croix-Rousse (additional listed site entries aggregated)

Germany

Earliest CTIS Part Ii Submission Date
14-07-2023
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
612
Number Of Sites
15
Number Of Participants
51

Sites

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

Italy

Earliest CTIS Part Ii Submission Date
14-07-2023
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
617
Number Of Sites
15
Number Of Participants
44

Sites

Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Clinica Oculistica Udine
Contact Person Name
Paolo Lanzetta
Contact Person Email
paolo.lanzetta@uniud.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Oculistica
Contact Person Name
Marco Lupidi
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Oculistica
Contact Person Name
Carlo Cagini
Contact Person Email
carlo.cagini@unipg.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di oculistica
Contact Person Name
Francesco Bandello
Contact Person Email
bandello.francesco@hsr.it
Site Name
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
UR Retina Medica
Contact Person Name
Maria cristina Parravano
Site Name
Careggi University Hospital
Department Name
Oculistica
Contact Person Name
Fabrizio Giansanti
Contact Person Email
fabrizio.giansanti@unifi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oftalmologia
Contact Person Name
Angelo Maria Minnella
Site Name
Ospedale Pediatrico Giovanni XXIII, AOU Consorziale Policlinico di Bari
Department Name
Oculistica
Contact Person Name
Francesco Boscia
Contact Person Email
francescoboscia@hotmail.com
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oculistica
Contact Person Name
Michele Reibaldi
Contact Person Email
michele.reibaldi@unito.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Oculistica
Contact Person Name
Grazia Pertile
Contact Person Email
grazia.pertile@sacrocuore.it
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Centro Oculistico
Contact Person Name
Mario Romano
Contact Person Email
Mario.romano.md@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Oculistica
Contact Person Name
Francesco Viola
Site Name
ASST Fatebenefratelli Sacco
Department Name
Oculistica
Contact Person Name
Giovanni Staurenghi
Contact Person Email
giovanni.sturenghi@unimi.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Clinica Oculistica
Contact Person Name
Daniele Tognetto
Contact Person Email
tognetto@units.it
Site Name
Additional listed Italian sites (aggregated)

Spain

Earliest CTIS Part Ii Submission Date
14-07-2023
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
586
Number Of Sites
18
Number Of Participants
40

Sites

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

Austria

Earliest CTIS Part Ii Submission Date
14-07-2023
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
975
Number Of Sites
2
Number Of Participants
8

Sites

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

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
Global CRO
Name
Icon Clinical Research Limited
Responsibilities
Sponsor third party with duties code 8 (role specified in CTIS record)

Third parties

  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Steinbeis-Forschungszentrum Grade Reading Center","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Site communication and documentation sharing tool","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Global CRO","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":"Cenetron Diagnostics Ltd.","duties_or_roles":"Ancillary Surgical Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Chillibean Limited","duties_or_roles":"Surgical Video Scrubbing and Respository","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO4893594
Active Substance
RANIBIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IMPLANTATION
Route
IMPLANTATION
Authorisation Status
Not authorised (investigational) based on prodAuthStatus:1
Maximum Dose
6 mg (maxTotalDoseAmount: 6 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
6 mg (maxTotalDoseAmount: 6 mg)
Combination Treatment
Yes

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