Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
998
Countries
16
Sites
61
Neovascular Age-related Macular Degeneration (wet AMD)
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD
Key facts
- Sponsor
- Opthea Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 27 Aug 2021 → 31 Mar 2025
- Decision date (initial)
- 2024-09-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Opthea Limited
External identifiers
- EU CT number
- 2024-512880-30-00
- EudraCT number
- 2020-004694-46
- ClinicalTrials.gov
- NCT04757636
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety, Efficacy
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD
Secondary objectives 1
- The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept from Baseline to (and at) Week 52 as determined by: Efficacy: • Changes in ETDRS BCVA letter score
Conditions and MedDRA coding
Neovascular Age-related Macular Degeneration (wet AMD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10071129 | Neovascular age-related macular degeneration | 100000004853 |
| 20.1 | LLT | 10067791 | Wet macular degeneration | 10015919 |
| 20.0 | SOC | 10015919 | Eye disorders | 9 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 1. Male or female participants at least 50 years of age.
- 2. Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
- 3. An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
Exclusion criteria 2
- Study Eye • Any previous treatment for neovascular AMD.
- Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean change from Baseline to Week 52 in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters.
Secondary endpoints 2
- Efficacy: - Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52 - Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52
- - Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52 - Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD5870808 · Product
- Active substance
- Vascular Endothelial Growth Factor Receptor 3 Extracellular Domains 1-3 Fused to a IGG1 Fc Fragment
- Substance synonyms
- VEGFR-3 EXTRACELLULAR DOMAINS 1-3 FUSED TO A IGG1 FC FRAGMENT, OPT-302
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 48 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- OPTHEA LTD
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 4
Eylea 40 mg/mL solution for injection in pre-filled syringe
PRD701247 · Product
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 48 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/001
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eylea 40 mg/mL solution for injection in pre-filled syringe
PRD3456172 · Product
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 48 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/001
- MA holder
- BAYER AG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eylea 40 mg/mL solution for injection in pre-filled syringe
PRD3117102 · Product
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 48 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/001
- MA holder
- BAYER AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eylea 40 mg/mL solution for injection in pre-filled syringe
PRD3117105 · Product
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 48 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/001
- MA holder
- BAYER AG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sham injection, intravitreal use, mimic OPT-302 injection
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Opthea Limited
- Sponsor organisation
- Opthea Limited
- Address
- 650 Chapel Street
- City
- South Yarra
- Postcode
- 3141
- Country
- Australia
Scientific contact point
- Organisation
- Opthea Limited
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Opthea Limited
- Contact name
- Clinical Trial Information
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Code 12, Code 2, Code 5, Code 8 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring, Code 10, Code 11, Code 12, Other, Code 2, Data management, E-data capture, Code 8, Code 9 |
Locations
16 EU/EEA countries · 61 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 1 |
| Bulgaria | Ended | 4 | 1 |
| Croatia | Ended | 27 | 3 |
| Czechia | Ended | 125 | 6 |
| Estonia | Ended | 16 | 3 |
| France | Ended | 6 | 2 |
| Germany | Ended | 2 | 2 |
| Greece | Ended | 25 | 3 |
| Hungary | Ended | 76 | 7 |
| Italy | Ended | 23 | 7 |
| Latvia | Ended | 26 | 2 |
| Lithuania | Ended | 17 | 3 |
| Netherlands | Ended | 5 | 2 |
| Poland | Ended | 83 | 6 |
| Slovakia | Ended | 20 | 4 |
| Spain | Ended | 16 | 9 |
| Rest of world
Canada, Philippines, Australia, United Kingdom, Argentina, Israel, Korea, Republic of, Colombia, United States, Puerto Rico, India, Brazil, Taiwan
|
— | 523 | — |
Investigational sites
Medical University Of Graz
Department of Ophthalmology, Neue Stiftingtalstrasse 6, 8010, Graz
MBAL Trakia EOOD
Eye diseases department, Bulevard Sveti Patriarh Evtimiy 84, 6000, Stara Zagora
Oftalmoloska Poliklinika Dr. Balog d.o.o.
Ophthalmology Polyclinic dr. Balog, Ivana Gundulica 36b, 31000, Osijek
KBC Split
Clinic for eye diseases, Spinciceva 1, 21000, Split
Klinicki Bolnicki Centar Osijek
DEPARTMENT OF POSTERIOR SEGMENT OF THE EYE, NEURO-OPHTHALMOLOGY, CHILDREN'S OPHTHALMOLOGY AND STRABO, Ulica Josipa Huttlera 4, 31000, Osijek
Fakultni Nemocnice Kralovske Vinohrady
Ocni oddeleni, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Hradec Kralove
Ocni klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Vseobecna Fakultni Nemocnice V Praze
Ocni klinika, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Thomayerova nemocnice
Ocni oddeleni, Videnska 750/800, Krc, Prague 4
Axon Clinical s.r.o.
Ocni klinika, Ostrovskeho 253/3, Smichov, Prague 5
Fakultni Nemocnice Brno
Ocni klinika, Jihlavska 340/20, Bohunice, Brno
Silmaarst Krista Turman OÜ
N/A, Jarve Tn 2, Kristiine Linnaosa, Tallinn
East Tallinn Central Hospital
N/A, Ravi Tn 18, Kesklinna Linnaosa, Tallinn
Silmalaser OÜ
N/A, Katusepapi Tn 6, Lasnamae Linnaosa, Tallinn
Assistance Publique Hopitaux De Paris
Hopital Lariboisiere - Ophtalmologie, 2 Rue Ambroise Pare, 75010, Paris
Centre Hospitalier Universitaire De Dijon
Service d’Ophtalmologie, 14 Rue Paul Gaffarel, 21000, Dijon
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinisches Studienzentrum der Augenklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Tuebingen AöR
Augenklinik, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
University General Hospital Attikon
B’ University Ophthalmology Clinic, Rimini Street 1, 124 62, Athens
University General Hospital Of Heraklion
Ophthalmology Clinic, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Larissa
Ophthalmology Clinic, P. O. Box 1425, 411 10, Larissa
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Department of Ophthalmology, Maglodi Ut 89-91, Kerulet, Budapest
Central Hospital Of Northern Pest Military Hospital
Department of Ophthalmology, Podmaniczky Utca 109, 1062, Budapest VI
University Of Debrecen
Ophthalmology Clinic, Nagyerdei Korut 98, 4032, Debrecen
Nozologen Kft.
Ophthalmology Center, Varady Antal Utca 10 Fszt. 5, 7621, Pecs
University Of Pecs
Department of Ophthalmology, Rakoczi Ut 2, 7623, Pecs
Zala Varmegyei Szent Rafael Korhaz
Department of Ophthalmology, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Semmelweis University
Ophthalmology Clinic, Rokk Szilard Utca 13, 1085, Budapest VIII
ASST Fatebenefratelli Sacco
Oculistica, Via Giovanni Battista Grassi 74, 20157, Milan
Hospital Santa Maria Della Misericordia
Oculistica, Piazzale Giorgio Menghini 1, 06129, Perugia
Ospedale San Raffaele S.r.l.
U.O.di Oculistica, Via Olgettina 60, 20132, Milan
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
UOC Oculistica, Via Livenza 3, 00198, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Oculistic, Via Francesco Sforza 35, 20122, Milan
Humanitas Mirasole S.p.A.
U.O. Oculistica, Via Alessandro Manzoni 56, 20089, Rozzano
Careggi University Hospital
Oculistica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Rigas Austrumu kliniska universitates slimnica SIA
Clinical Centre "Bikernieki", Hipokrata Iela 2, 1038, Riga
Pauls Stradins Clinical University Hospital
N/A, Pilsonu Iela 13, 1002, Riga
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
N/A, Eiveniu G. 2, Kauno M. Sav., Kaunas
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
N/A, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Klaipedos universiteto ligonine VšĮ
N/A, Liepojos G. 41, Klaipedos M. Sav., Klaipeda
The Rotterdam Eye Hospital
Ophthalmology, Schiedamse Vest 180, 3011 BH, Rotterdam
Stichting Elisabeth-Tweesteden Ziekenhuis
Ophthalmology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Oftalmika Sp. z o.o.
Klinika Okulistyczna OFTALMIKA Sp. z o.o., Ul. Modrzewiowa 15, 85-631, Bydgoszcz
Mackiewicz Okulistyka Sp. z o.o.
NA, Ul. Polnocna 5/u9, 20-064, Lublin
Santa Sp. z o.o.
ETG Lodz, Pilota Stanislawa Wigury 19, 90-302, Lodz
Poznanskie Centrum Wzroku Sp. z o.o.
NA, Ul. Koscielna 26/1, 60-538, Poznan
Oculomedica Sp. z o.o.
Specjalistyczny Osrodek Okulistyczny Oculomedica, Gorzyskowo 14, 85-157, Bydgoszcz
Szpital Swietego Lukasza S.A.
Poradnia Okulistyczna, Ul. Bystrzanska 94b, 43-309, Bielsko-Biala
Fakultna Nemocnica S Poliklinikou Zilina
Oftalmologicka ambulancia, Vojtecha Spanyola 43, 010 01, Zilina
Fakultna Nemocnica Trencín
Ocna klinika, Legionarska 28, 911 01, Trencin
Nemocnica S Poliklinikou Trebisov a.s.
Oftalmologicka ambulancia, Slov. Nar. Povstania 76, 075 01, Trebisov
University Hospital Bratislava
Klinika oftalmologie LFUK a UNB, Ruzinovska 6, Ruzinov, Bratislava
Hospital Universitario Puerta De Hierro De Majadahonda
Ophthalmology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Instituto Oftalmologico Fernandez-Vega S.L.
Ophthalmology, Principado De Asturias, Avenida Doctores Fernandez Vega 34, Oviedo
Hospital Germans Trias I Pujol
Ophthalmology, Carretera Canyet 1a Planta, 08916, Badalona
Institut Catala De Retina S.L.
Ophthalmology, Calle De La Pau Alcover 67, 08017, Barcelona
Hospital Clinico Universitario Lozano Blesa
Ophthalmology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
Ophthalmology, Avenida Cataluna 21, 46020, Valencia
Bellvitge University Hospital
Ophthalmology, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Universitario Miguel Servet
Ophthalmology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Ophthalmology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2022-03-18 | 2022-05-17 | 2024-02-13 | ||
| Bulgaria | 2022-07-14 | 2022-09-21 | 2024-02-13 | ||
| Croatia | 2022-04-19 | 2022-05-16 | 2024-02-13 | ||
| Czechia | 2021-09-21 | 2021-10-04 | 2024-02-13 | ||
| Estonia | 2021-08-27 | 2021-12-13 | 2024-02-13 | ||
| France | 2021-12-02 | 2021-12-14 | 2024-02-13 | ||
| Germany | 2022-04-06 | 2022-06-13 | 2024-02-13 | ||
| Greece | 2021-12-21 | 2021-12-22 | 2024-02-13 | ||
| Hungary | 2021-10-13 | 2021-10-29 | 2024-02-13 | ||
| Italy | 2021-11-19 | 2022-01-25 | 2024-02-13 | ||
| Latvia | 2021-11-01 | 2021-11-03 | 2024-02-13 | ||
| Lithuania | 2021-12-07 | 2021-12-13 | 2024-02-13 | ||
| Netherlands | 2022-01-12 | 2022-01-18 | 2024-02-13 | ||
| Poland | 2022-02-03 | 2022-02-09 | 2024-02-13 | ||
| Slovakia | 2021-11-26 | 2022-02-21 | 2024-02-13 | ||
| Spain | 2022-01-13 | 2022-03-29 | 2024-02-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| COAST_OPT-302-1005_Summary SUM-88787
|
2025-07-01T17:39:42 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| COAST_OPT-302-1005_Layperson_Summary | 2025-07-01T17:41:13 | Submitted | Laypersons Summary of Results |
Documents 59 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | COAST_OPT-302-1005_Layperson_Summary | N/A |
| Protocol (for publication) | D1_Protocol_ENG_2024-512880-30-00_redacted | 2.0 AM.1 |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Blank document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document | N/A |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main ICF_HUN_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF GDPR_site 863_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HRV_hr_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Collection storage and use of biological samples_HRV_hr_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_HRV_hr_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CoT for RUS ICF_Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_SK_Redacted | V1.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GreenPhire_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_GRC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_site 863_Redacted | 1.3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_site 864_Redacted | 1.3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_AT_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EST_Redacted | 1.2EST(ET) |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_LAV_Redacted | 1.2a(LV)02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_LIT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_Redacted | 1.2EST(RU) |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_Redacted | 1.2a(RU)02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SK_Redacted | V1.2SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_DE_Redacted | 1.4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Notice for Main_SK_Redacted | V2.0SVK3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Main PIS_HUN_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Adult_IT_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_686_IT_Redacted | 686v1.0A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_688_IT_Redacted | 688v1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_691_IT_Redacted | 691v1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_695_IT_Redacted | 695v1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Blank document | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Eylea | N/A |
| Summary of results (for publication) | COAST_OPT-302-1005_Summary | N/A |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | Czechia | Acceptable with conditions 2024-08-28
|
2024-08-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-20 | Acceptable with conditions 2024-08-28
|
2024-12-20 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-13 | Czechia | Acceptable 2025-04-16
|
2025-04-16 |