Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
986
Countries
10
Sites
39
Neovascular age-related macular degeneration (wet AMD)
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, 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
- 23 Sep 2021 → 31 Mar 2025
- Decision date (initial)
- 2024-09-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Opthea Limited
External identifiers
- EU CT number
- 2024-512879-13-00
- EudraCT number
- 2020-004736-24
- ClinicalTrials.gov
- NCT04757610
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety, Pharmacokinetic
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMD.
Secondary objectives 1
- To determine the effects of the addition of intravitreal 2.0 mg OPT-302 to intravitreal 0.5 mg ranibizumab from Baseline to (and at) Week 52 in terms of: Efficacy: Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letter score
Conditions and MedDRA coding
Neovascular age-related macular degeneration (wet AMD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10067791 | Wet macular degeneration | 10015919 |
| 27.0 | PT | 10071129 | Neovascular age-related macular degeneration | 100000004853 |
| 20.0 | SOC | 10015919 | Eye disorders | 9 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-004736-24 | A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD), Název klinického hodnocení: Multicentrické dvojitě maskované randomizované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost intravitreálně podávaného přípravku OPT-302 v kombinaci s ranibizumabem ve srovnání s ranibizumabem samotným u účastníků s neovaskulární věkem podmíněnou makulární degenerací (nAMD) (ShORe), Název klinického hodnocení: Multicentrické dvojitě maskované randomizované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost intravitreálně podávaného přípravku OPT-302 v kombinaci s ranibizumabem ve srovnání s ranibizumabem samotným u účastníků s neovaskulární věkem podmíněnou makulární degenerací (nAMD) (ShORe), Název klinického hodnocení: Multicentrické dvojitě maskované randomizované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost intravitreálně podávaného přípravku OPT-302 v kombinaci s ranibizumabem ve srovnání s ranibizumabem samotným u účastníků s neovaskulární věkem podmíněnou makulární degenerací (nAMD) (ShORe), Název klinického hodnocení: Multicentrické dvojitě maskované randomizované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost intravitreálně podávaného přípravku OPT-302 v kombinaci s ranibizumabem ve srovnání s ranibizumabem samotným u účastníků s neovaskulární věkem podmíněnou makulární degenerací (nAMD) (ShORe), Název klinického hodnocení: Multicentrické dvojitě maskované randomizované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost intravitreálně podávaného přípravku OPT-302 v kombinaci s ranibizumabem ve srovnání s ranibizumabem samotným u účastníků s neovaskulární věkem podmíněnou makulární degenerací (nAMD) (ShORe), Název klinického hodnocení: Multicentrické dvojitě maskované randomizované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost intravitreálně podávaného přípravku OPT-302 v kombinaci s ranibizumabem ve srovnání s ranibizumabem samotným u účastníků s neovaskulární věkem podmíněnou makulární degenerací (nAMD) (ShORe), III. fázisú vizsgálat az intravitreálisan, ranibizumabbal kombinációban alkalmazott OPT-302 és az önmagában alkalmazott ranibizumab összehasonlítására neovaszkuláris életkorral összefüggő makuladegenerációban (age-related macular degeneration, AMD) szenvedő résztvevők esetében, III. fázisú vizsgálat az intravitreálisan, ranibizumabbal kombinációban alkalmazott OPT-302 és az önmagában alkalmazott ranibizumab összehasonlítására neovaszkuláris életkorral összefüggő makuladegenerációban (age-related macular degeneration, AMD) szenvedő résztvevők esetében, Estudio en fase III, aleatorizado, con doble ciego y multicéntrico para evaluar la eficacia y la seguridad de OPT-302 intravítreo en combinación con ranibizumab, comparado con ranibizumab en monoterapia, en participantes con degeneración macular asociada a la edad (DMAE) neovascular, Estudio en fase III, aleatorizado, con doble ciego y multicéntrico para evaluar la eficacia y la seguridad de OPT-302 intravítreo en combinación con ranibizumab, comparado con ranibizumab en monoterapia, en participantes con degeneración macular asociada a la edad (DMAE) neovascular, Studio di fase 3, multicentrico, in doppio cieco, randomizzato, per valutare l’efficacia e la sicurezza di OPT-302 intravitreale in combinazione con ranibizumab, rispetto a ranibizumab in monoterapia, in pazienti affetti da degenerazione maculare neovascolare legata all’età (DMLE) |
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: 1. • Any previous treatment for neovascular AMD.
- 3. • Clinically significant ocular disorders (other than neovascular AMD), which may, in the investigator's opinion, 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 ETDRS 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
Lucentis 10 mg/ml solution for injection in pre-filled syringe
PRD3945695 · Product
- Active substance
- Ranibizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA04 — -
- Marketing authorisation
- EU/1/06/374/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lucentis 10 mg/ml solution for injection in pre-filled syringe
PRD3945687 · Product
- Active substance
- Ranibizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA04 — -
- Marketing authorisation
- EU/1/06/374/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lucentis 10 mg/ml solution for injection in pre-filled syringe
PRD3945691 · Product
- Active substance
- Ranibizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01LA04 — -
- Marketing authorisation
- EU/1/06/374/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 0.5 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 96 Week(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
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 1
| Organisation | City, country | Duties |
|---|---|---|
| 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
10 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 72 | 4 |
| Denmark | Ended | 3 | 2 |
| France | Ended | 4 | 2 |
| Germany | Ended | 6 | 4 |
| Greece | Ended | 14 | 3 |
| Hungary | Ended | 5 | 2 |
| Italy | Ended | 32 | 7 |
| Latvia | Ended | 4 | 1 |
| Poland | Ended | 37 | 6 |
| Spain | Ended | 121 | 8 |
| Rest of world
Ukraine, Canada, Israel, United Kingdom, Korea, Republic of, Brazil, United States, Australia, Thailand, India, Argentina, Malaysia
|
— | 688 | — |
Investigational sites
Oftex s.r.o.
Ocni klinika, Rokycanova 2798, Zelene Predmesti, Pardubice V
Klinika JL MR s.r.o.
Ocni klinika, V Hurkach 1296/10, Stodulky, Prague
Medical Private Care s.r.o.
Ocni oddeleni, Slovenska 545, 356 01, Sokolov
Fakultni Nemocnice Kralovske Vinohrady
Oftalmologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Rigshospitalet
Department of Ophthalmology, Valdemar Hansens Vej 1-23, 2600, Glostrup
Aarhus Universitetshospital
Department of Ophthalmology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Pole Vision Val D'Ouest
Ophtalmologie, 39 Chemin De La Vernique, 69130, Ecully
Centre Hospitalier Universitaire De Nice
Ophtalmologie, 30 Voie Romaine, 06000, Nice
Universitaetsmedizin Goettingen
Augenklinik, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Ulm AöR
Klinik für Augenheilkunde, Prittwitzstrasse 43, Mitte, Ulm
Universitaetsklinikum Heidelberg AöR
-, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitaetsklinikum Muenster AöR
-, Albert-Schweitzer-Campus 1, Sentrup, Muenster
General University Hospital Of Patras
Ophthalmology Clinic, Rio, 265 04, Patras
University General Hospital Of Ioannina
Ophthalmologic Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
General Hospital Of Athens G Gennimatas
1st University Eye Clinic, Messogion Avenue 154, 115 27, Athens
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Ophthalmology, Szentpeteri Kapu 72-76, 3526, Miskolc
Budapest Retina Associates Kft.
Ophthalmology, Vaci Ut 76, Kerulet, Budapest XIII
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oculistica, Largo Francesco Vito 1, 00168, Rome
IRCCS Ospedale Policlinico San Martino
Clinica Oculistica - Centro Retina e Maculopatie, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Sanitaria Universitaria Friuli Centrale
Clinica oculistica, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O. Oftalmologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Senese
U.O.C. Oculistica, Viale Mario Bracci 1, 53100, Siena
Azienda Ospedaliero Universitaria Renato Dulbecco
U.O. Oculistica, Viale Europa, 88100, Catanzaro
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Clinica Oftalmologica Chieti, Via Dei Vestini Snc, 66100, Chieti
Eb Group Sp. z o.o.
Centrum Zdrowia MDM, Ul. Inflancka 4a, 00-189, Warsaw
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
N/A, Ul. Budowlana 3a, 10-424, Olsztyn
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Okulistyki, Ul. Borowska 213, 50-556, Wroclaw
Caminomed Sp. z o.o.
Caminomed, Ul. Kardynala Stefana Wyszynskiego 3a, 42-600, Tarnowskie Gory
Centrum Medyczne Dietla 19 Sp. z o.o.
N/A, Ul. Jozefa Dietla 19/3, 31-070, Cracow
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
II Klinika Okulistyki, Ul. Powstancow Wielkopolskich 72, 70-111, Szczecin
Centro De Oftalmologia Barraquer S.A.
Ophthalmology, Calle Muntaner 314, 08021, Barcelona
Hospital Arnau De Vilanova De Valencia
Ophthalmology, Calle De San Clemente 12, 46015, Valencia
Hospital Universitari General De Catalunya
Ophthalmology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Instituto De Microcirugia Ocular Dos S.L.
Ophthalmology, Calle Del Valle De Pinares Llanos 3, 28035, Madrid
Hospital Clinico San Carlos
Unidad de Retina, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Clinica De Oftalmologia De Cordoba S.L.
Ophthalmology, Avenida De La Arruzafa 9, 14012, Cordoba
Oftalmologia Vistahermosa S.L.
Ophthalmology, Avenida De La Ilustracion 1, Poligono Industrial De Burjassot, Burjassot
Hospital Universitario De Burgos
Ophthalmology, Avenida De Las Islas Baleares 3, 09006, Burgos
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 |
|---|---|---|---|---|---|
| Czechia | 2021-09-23 | 2021-09-27 | 2024-05-24 | ||
| Denmark | 2022-02-21 | 2022-03-28 | 2024-05-24 | ||
| France | 2021-11-04 | 2022-01-03 | 2024-05-24 | ||
| Germany | 2021-11-19 | 2022-04-21 | 2024-05-24 | ||
| Greece | 2022-02-15 | 2022-02-23 | 2024-05-24 | ||
| Hungary | 2022-01-14 | 2022-03-07 | 2024-05-24 | ||
| Italy | 2021-12-14 | 2021-12-23 | 2024-05-24 | ||
| Latvia | 2021-11-01 | 2021-11-23 | 2024-05-24 | ||
| Poland | 2021-12-13 | 2021-12-22 | 2024-05-24 | ||
| Spain | 2021-10-01 | 2021-10-04 | 2024-05-24 |
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 |
|---|---|---|---|
| ShORe_OPT-302-1004_Summary SUM-88780
|
2025-07-01T17:26:09 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| ShORe_OPT-302-1004_Layperson_Summary | 2025-07-01T17:27:47 | Submitted | Laypersons Summary of Results |
Documents 33 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | ShORe_OPT-302-1004_Layperson_Summary | 1.1 |
| Protocol (for publication) | D1_Protocol_ENG_2024-512879-13-00_redacted | 2.0 |
| 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_Placeholder statement | N/A |
| 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_SIS and ICF Main Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DK_redacted | 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_Future Research_Redacted | 1.0 |
| 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_Main ICF_ESP_Redacted | 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_LAV_Redacted | (LV)02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RUS_Redacted | (RU)02 |
| 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_296_IT_Redacted | 296v1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_298_IT_Redacted | 298v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_300_IT_Redacted | 300v1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research_IT_Redacted | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Pregnancy FU_Redacted | 1.2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lucentis | N/A |
| Summary of results (for publication) | ShORe_OPT-302-1004_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 | 2024-08-02 | Czechia | Acceptable with conditions 2024-09-05
|
2024-09-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-20 | Acceptable with conditions 2024-09-05
|
2024-12-20 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-13 | Czechia | Acceptable 2025-04-17
|
2025-04-17 |