Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
561
Countries
13
Sites
74
Neovascular age-related macular degeneration
To evaluate anti-VEGF injection burden and long-term efficacy after subretinal surabgene lomparvovec administration, compared to PRN intravitreal ranibizumab given per protocol specified criteria during Year 1, and subsequently compared to a PRN intravitreal ranibizumab schedule that mimics the real-world clinic settin…
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 18 Dec 2025 → ongoing
- Decision date (initial)
- 2025-12-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate anti-VEGF injection burden and long-term efficacy after subretinal surabgene lomparvovec administration, compared to PRN intravitreal ranibizumab given per protocol specified criteria during Year 1, and subsequently compared to a PRN intravitreal ranibizumab schedule that mimics the real-world clinic setting after Year 1.
Conditions and MedDRA coding
Neovascular age-related macular degeneration
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10071129 | Neovascular age-related macular degeneration | 100000004853 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency, Japan Pharmaceutical Manufacturers Association
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 [Week –6]) in the study eye
- Must have a diagnosis of CNV secondary to AMD in the study eye
- Must have received at least 2 intravitreal anti-VEGF injections in the past 6 months in the study eye prior to Screening Visit 1 (Week –6) and have been responsive (determined by investigator)
Exclusion criteria 4
- CNV or macular edema in the study eye that is secondary to any causes other than AMD.
- Study eye with nAMD diagnosed > 4 years from Screening Visit 1
- Any subretinal hemorrhage in the study eye > 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center.
- History of retinal detachment, retinal tear or macular hole in the study eye that, in the opinion of the investigator, may preclude successful subretinal injection of surabgene lomparvovec.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.
Secondary endpoints 4
- Change from Baseline in BCVA at Year 3.
- Annualized intravitreal anti-VEGF injection rate from Week 6 through Year 3.
- Incidence and severity of ocular AEs in the study eye and contralateral eye
- Change from Baseline in area of macular atrophy based on FAF at assessed time points in the study eye
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Surabgene Lomparvovec (ABBV-RGX-314)
PRD10384962 · Product
- Active substance
- Surabgene Lomparvovec
- Substance synonyms
- Adeno-associated viral vector serotype 8 encoding a human antigen-binding fragment against vascular endothelial growth factor, RGX-314, AAV8.CB7.CI.amd42.RBG, ABBV-RGX-314
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBRETINAL USE
- Max daily dose
- 00 µl microlitre(s)
- Max total dose
- 00 µl microlitre(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Surabgene Lomparvovec (ABBV-RGX-314)
PRD10384961 · Product
- Active substance
- Surabgene Lomparvovec
- Substance synonyms
- Adeno-associated viral vector serotype 8 encoding a human antigen-binding fragment against vascular endothelial growth factor, RGX-314, AAV8.CB7.CI.amd42.RBG, ABBV-RGX-314
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBRETINAL USE
- Max daily dose
- 00 µl microlitre(s)
- Max total dose
- 00 µl microlitre(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Lucentis 10 mg/ml solution for injection in pre-filled syringe
PRD2393542 · Product
- Active substance
- Ranibizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01LA04 — -
- Marketing authorisation
- EU/1/06/374/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management, E-data capture |
| Merit CRO Inc. ORG-100042167
|
Madison, United States | Other |
| Azenta US Inc. ORG-100012907
|
South Plainfield, United States | Laboratory analysis |
| Optymedge LLC ORG-100045359
|
Rockville, United States | Other |
| Avantor Inc. ORG-100050885
|
Wayne, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Cary, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Interactive response technologies (IRT) |
| Veranex Inc. ORG-100046478
|
Raleigh, United States | Other |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Other |
Locations
13 EU/EEA countries · 74 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 20 | 5 |
| Belgium | Authorised, recruiting | 8 | 2 |
| Bulgaria | Ongoing, recruiting | 16 | 4 |
| Croatia | Ongoing, recruiting | 12 | 3 |
| Czechia | Authorised, recruiting | 20 | 5 |
| France | Ongoing, recruiting | 40 | 12 |
| Germany | Ongoing, recruiting | 40 | 12 |
| Greece | Ongoing, recruiting | 16 | 4 |
| Hungary | Ongoing, recruiting | 16 | 4 |
| Italy | Ongoing, recruiting | 20 | 6 |
| Portugal | Authorised, recruiting | 12 | 3 |
| Slovakia | Authorised, recruitment pending | 12 | 3 |
| Spain | Ongoing, recruiting | 40 | 11 |
| Rest of world
Israel, Canada, Puerto Rico, Switzerland, United States, United Kingdom
|
— | 289 | — |
Investigational sites
Johannes Kepler University Linz
Department of Ophthalmology and Optometry, Med Campus III, Krankenhausstrasse 9, Linz
Medical University Of Graz
Department of Ophthalmology, Neue Stiftingtalstrasse 6, 8010, Graz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Opthalmology, Muellner Hauptstrasse 48, 5020, Salzburg
NOE Landesgesundheitsagentur
Department of Opthalmology, Liechtensteinstrasse 67, 2130, Mistelbach
Medizinische Universitaet Innsbruck
Department of Ophthalmology and Optometry, Anichstrasse 35, 6020, Innsbruck
Universitair Ziekenhuis Gent
Oogheelkunde, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Oogheelkunde, Herestraat 49, 3000, Leuven
Specialized Hospital For Active Treatment Of Eye Diseases Zora OOD
Department - Eye Diseases, Petar Protich Str 4, 1784, Sofia
Medical Center Vereya EOOD
N/A, Ulitsa Kenali 4, 6008, Stara Zagora
Assoc. Prof. Dr. Desislava Koleva Outpatient clinic for individual practice for specialized medical assistance in eye diseases "St. Luka" EOOD
N/A, Floor 2, Ulitsa Perushtitsa 13b, Plovdiv
Specialized Eye Hospital For Active Treatment Burgas OOD
Department - Eye Diseases, Georgi Minkov Str. 174, Slaveykov Res Complex, Burgas
Specijalna bolnica Svjetlost
Ophthalmology, Ulica Vjekoslava Heinzela 39, 10000, Zagreb
University Hospital Centre Zagreb
Ophthalmology, Ulica Mije Kispatica 12, 10000, Zagreb
University Hospital Sveti Duh
Ophthalmology, Sveti Duh 64, 10000, Zagreb
Vseobecna Fakultni Nemocnice V Praze
Ocni klinika VFN, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Ostrava
Ocni klinika FNO, 17. Listopadu 1790/5, Poruba, Ostrava
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Ocni klinika UVN, U Vojenske Nemocnice 1200, 169 02, Prague 6
Fakultni Nemocnice Kralovske Vinohrady
Oftalmologická klinika, Srobarova 1150/50, Vinohrady, Prague
Axon Clinical s.r.o.
Ocni oddeleni, Ostrovskeho 253/3, Smichov, Prague 5
Centre Monticelli Paradis D Ophtalmologie
Ophthalmology, 433 Rue Paradis, 13008, Marseille
Institut Ophtalmologique De l'Ouest Jules Verne
Clinique Jules Verne, 2 Route De Paris, 44300, Nantes
Centre Hospitalier Intercommunal Creteil
Ophthalmology, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Universitaire De Nantes
Ophthalmology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
Ophthalmology, 28 Rue De Charenton, 75012, Paris
Centre Hospitalier Universitaire De Nice
Ophthalmology, 30 Voie Romaine, 06000, Nice
Pole Vision Val D'Ouest
Ophthalmology, 39 Chemin De La Vernique, 69130, Ecully
Centre Hospitalier Universitaire De Bordeaux
Ophthalmology, Place Amelie Raba Leon, 33000, Bordeaux
Hospital Edouard Herriot
Ophthalmology, 5 Place D Arsonval, 69003, Lyon
Fondation A De Rothschild
Ophthalmology, 25 Rue Manin, 75019, Paris
Clinique Juge
Ophtalmology, 116 Rue Jean Mermoz, 13008, Marseille
Selarl Retine Tourny
Centre Rétine Galien, 68 Rue Du Palais Gallien, 33000, Bordeaux
Medical Center - University Of Freiburg
Klinik fuer Augenheilkunde, Killianstrasse 5, Stuehlinger, Freiburg Im Breisgau
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Augenklinik, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
Charite Universitaetsmedizin Berlin KöR
Klinik fuer Augenheilkunde, Hindenburgdamm 30, Lichterfelde, Berlin
Medizinische Hochschule Hannover
Universitaetsklinik fuer Augenheilkunde, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Tuebingen AöR
Universitaets-Augenklinik, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
Universitaetsmedizin Goettingen
Klinik fuer Augenheilkunde, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Bonn AöR
Klinik fuer Augenheilkunde, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Schleswig-Holstein AöR
Klinik fuer Augenheilkunde, Ratzeburger Allee 160, 23538, Luebeck
University Medical Center Hamburg-Eppendorf
Augenheilkunde, Martinistrasse 52, Eppendorf, Hamburg
LMU Klinikum Muenchen AöR
Augenklinik und Poliklinik, Mathildenstrasse 8, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Ulm AöR
Klinik fuer Augenheilkunde, Prittwitzstrasse 43, Mitte, Ulm
Universitaet Muenster
Klinik fuer Augenheilkunde, Albert-Schweitzer-Campus 1, Sentrup, Muenster
General Hospital Of Athens G Gennimatas
First University Ophthalmology Department, Messogion Avenue 154, 115 27, Athens
General University Hospital Of Larissa
University Eye Clinic, P. O. Box 1425, 411 10, Larissa
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd University Department of Ophthalmology, Rimini 1, 124 61, Chaidari
University General Hospital Of Heraklion
Ophthalmology Department, Stavrakia And Voutes, 715 00, Heraklion
Budapest Retina Associates Kft.
Budapest Retina Associates, Vaci Ut 76, Kerulet, Budapest XIII
Semmelweis University
Szemeszeti Klinika, Szemeszeti Klinikai Kutato Kozpont, Rokk Szilard Utca 13, 1085, Budapest VIII
University Of Debrecen
Szemklinika, Nagyerdei Korut 98, 4032, Debrecen
Nozologen Kft.
Ganglion Orvosi Kozpont, Varady Antal Utca 10 Fszt. 5, 7621, Pecs
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Oculistica, Via Cherasco 15, 10126, Turin
University Hospital Of Ferrara
Dipartimento di Medicina Traslazionale e per la Romagna, Via Aldo Moro 8, 44124, Ferrara
Azienda Ospedaliero Universitaria Delle Marche
Clinica Oculistica, Via Conca 71, 60126, Ancona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oculistica, Largo Francesco Vito 1, 00168, Rome
Azienda USL IRCCS Di Reggio Emilia
Ocular Immunology Unit, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliero Universitaria Careggi
SOD Ottica Fisiopatologica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Unidade Local De Saude De Sao Jose E.P.E.
Opthalmic Service, Rua Jose Antonio Serrano, 1150-199, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
Opthalmic Service, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Coimbra E.P.E.
Opthalmic Service, Praceta Professor Mota Pinto, 3004-561, Coimbra
University Hospital Bratislava
Ophtalmology, Antolska 11, Petrzalka, Bratislava
Fakultna Nemocnica Trencín
Ophtalmology, Legionarska 28, 911 01, Trencin
Fakultna Nemocnica S Poliklinikou Zilina
Ophtalmology, Vojtecha Spanyola 43, 010 01, Zilina
Centro De Oftalmologia Barraquer S.A.
Ophthalmology, Calle Muntaner 314, 08021, Barcelona
Hospital Universitario Donostia
Ophthalmology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitari Vall D Hebron
Ophthalmology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario Lozano Blesa
Ophthalmology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Puerta De Hierro De Majadahonda
Ophthalmology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario Virgen De La Macarena
Ophthalmology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Instituto Oftalmologico Fernandez-Vega S.L.
Ophthalmology, Principado De Asturias, Avenida Doctores Fernandez Vega 34, Oviedo
Hospital Universitario 12 De Octubre
Ophthalmology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Y Politecnico La Fe
Ophthalmology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Instituto Clinic De Oftalmologia
Ophthalmology, Calle De Sabino Arana Nº 1, 08028, Barcelona
Metavision Arruzafa S.L.
Ophthalmology, Avenida De La Arruzafa 9, 14012, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2026-01-30 | 2026-03-18 | |||
| Belgium | 2026-02-27 | ||||
| Bulgaria | 2026-02-04 | 2026-03-30 | |||
| Croatia | 2026-03-06 | 2026-05-26 | |||
| Czechia | 2026-03-30 | ||||
| France | 2025-12-29 | 2026-03-16 | |||
| Germany | 2026-01-20 | 2026-02-17 | |||
| Greece | 2026-02-24 | 2026-03-11 | |||
| Hungary | 2026-02-17 | 2026-03-09 | |||
| Italy | 2026-01-30 | 2026-02-18 | |||
| Portugal | 2026-02-20 | ||||
| Spain | 2025-12-18 | 2026-01-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 83 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m24528-protocol_public_Redacted | 2.2 |
| Protocol (for publication) | D1_m24528-protocol-GR_public_Redacted | 2.2 |
| Recruitment arrangements (for publication) | K1 M24-528 CZ Recruitment and ICF Procedures Public | 1 |
| Recruitment arrangements (for publication) | K1 M24-528 DE Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1 M24-528 ES Recruitment and IC Procedures | 1.0 |
| Recruitment arrangements (for publication) | K1 M24-528 PT Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1 M24-528 Recruitment and ICF Procedures Public | 1 |
| Recruitment arrangements (for publication) | K1 M24-528 Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1 M24-528 SK Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | K1_M24-528 AT Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M24-528 BE Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1_M24-528 FR Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1_M24-528 HR Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M24-528 IT Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_M24-528_BG_Recruitment and ICF Procedures Clean_Public | 1.1 |
| Recruitment arrangements (for publication) | K2 M24-528 DE Ad and Recruitment_Public Redacted | N/A |
| Subject information and informed consent form (for publication) | EU CTR Placeholder ICF Site Contact Details | 1 |
| Subject information and informed consent form (for publication) | L1 M24-528 CZ GDPR ICF Czech Public | 1 |
| Subject information and informed consent form (for publication) | L1 M24-528 CZ Main ICF Czech Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 CZ Optional ICF Czech Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 CZ PPA ICF Czech Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 DE ICF Main_public redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1 M24-528 DE ICF Pregnant Partner_public | 1.3 |
| Subject information and informed consent form (for publication) | L1 M24-528 ES Main ICF_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 ES Optional ICF_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 ES PP ICF_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 GR Informed Consent Main Public | 1 |
| Subject information and informed consent form (for publication) | L1 M24-528 GR Informed Consent Optional Public | 1 |
| Subject information and informed consent form (for publication) | L1 M24-528 GR Informed Consent Pregnant Partner Public | 1 |
| Subject information and informed consent form (for publication) | L1 M24-528 HU Main PIS and ICF Hungarian_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 HU Mandatory Genetic ICF Hungarian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 HU Mandatory Genetic PIS Hungarian_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 HU Pregnant Parter PIS and ICF Hungarian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 PT Main and Optional ICF_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1 M24-528 PT Pregnant ICF_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M24-528 SK ICF Main_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 SK ICF Optional | 1.1 |
| Subject information and informed consent form (for publication) | L1 M24-528 SK ICF Pregnant partner | 1 |
| Subject information and informed consent form (for publication) | L1 M24-528 SK ICF Privacy v1 0 25Jun2025_Public | 1 |
| Subject information and informed consent form (for publication) | L1_24-528_BG_ICF Pregnant Partner Bulgarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_24-528_BG_ICF Pregnant Partner English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 AT ICF Main_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M24-528 AT ICF PregPart_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Main ICF_Dutch_Public Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Main ICF_English_Public Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Main ICF_French_Public Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Optional ICF_Dutch_Public Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Optional ICF_English_Public Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Optional ICF_French_Public Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Pregnant Partner ICF_Dutch_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Pregnant Partner ICF_English_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M24-528 BE Pregnant Partner ICF_French_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M24-528 BG_ICF Main Bulgarian_Public Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 BG_ICF Main English_Public Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 FR ICF Main - Public Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_M24-528 FR ICF Pregnant Partner_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR ICF Greenphire_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR ICF Main_MS | 2.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR ICF Main_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR ICF Optional_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR ICF Pregnant Partner_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR Travel contact card | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 HR Travel reference guide | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528 IT ICF Main_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M24-528 IT ICF Optional_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_M24-528 IT Pregnancy_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M24-528_DE_ICF Optional Research_public | 1.2 |
| Subject information and informed consent form (for publication) | L2 EU CTR Blank document HU Patient Card_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_lucentis-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-BG-BG_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-CZ-CZ_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-DE-AT_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-EL-GR_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-ES-ES_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-HU-HU_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-IT-IT_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-Protocol-Synopsis-Lay Version-BE-Dutch | 3 |
| Synopsis of the protocol (for publication) | D1_m24528-Protocol-Synopsis-Lay Version-BE-French | 3 |
| Synopsis of the protocol (for publication) | D1_m24528-Protocol-Synopsis-Lay Version-BE-German | 3 |
| Synopsis of the protocol (for publication) | D1_m24528-Protocol-Synopsis-Lay Version-English | 3 |
| Synopsis of the protocol (for publication) | D1_m24528-Protocol-Synopsis-Lay Version-French | 3 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-PT-PT_public_Redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_m24528-protocol-synopsis-SK-SK_public_Redacted | 2.2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-17 | Spain | Acceptable 2025-12-01
|
2025-12-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-15 | Acceptable | 2026-01-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-26 | Acceptable | 2026-02-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-30 | Acceptable | 2026-02-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-09 | Spain | Acceptable | 2026-02-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-24 | Acceptable | 2026-03-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-13 | Acceptable | 2026-04-22 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-04-16 | Acceptable | 2026-05-11 |