Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
280
Countries
10
Sites
45
geographic atrophy
The objectives of this trial are to assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).
Key facts
- Sponsor
- Astellas Pharma Global Development Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 21 Dec 2022 → 11 Apr 2025
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515185-13-00
- EudraCT number
- 2022-002860-59
- ClinicalTrials.gov
- NCT05536297
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety
The objectives of this trial are to assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).
Conditions and MedDRA coding
geographic atrophy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10063947 | Geographic atrophy | 10015919 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment, regardless of whether they received treatment with avacincaptad pegol or Sham previously, refer to Section 8.2 of the ISEE2008 protocol for inclusion criteria details. Patients must provide new written informed consent for this OLE trial prior to participating and have the ability to return for all trial visits for the duration of the 18-month trial.
Exclusion criteria 4
- 1. Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham)
- 2. Any patients who had the study drug permanently withdrawn for an AE are not eligible; patients who had study drug temporarily withheld for an AE(s) or elective ocular surgery will be reviewed on case by case basis for eligibility
- 3. Patient did not enroll into this OLE trial within the 90 days enrollment period.
- 4. Patients who are pregnant or nursing
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- AEs
Secondary endpoints 2
- Immunogenicity
- Pharmacokinetics
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11465846 · Product
- Active substance
- Avacincaptad Pegol
- Substance synonyms
- ARC1905, ARC-1905
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 34 mg milligram(s)
- Max treatment duration
- 17 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SCP152172 · ATC
- Active substance
- Fluorescein Sodium
- Substance synonyms
- FLUORESCEIN DISODIUM
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 0
- Max treatment duration
- 17 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01JA01 — FLUORESCEIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Global Development Inc.
- Sponsor organisation
- Astellas Pharma Global Development Inc.
- Address
- 2375 Waterview Drive
- City
- Northbrook
- Postcode
- 60062-6145
- Country
- United States
Scientific contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Clinical Trial Unit Head
Public contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Clinical Trial Unit Head
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Duke University ORG-100051387
|
Durham, United States | Other |
| International Drug Development Institute Inc. ORG-100045710
|
Raleigh, United States | E-data capture |
| Global Eye Trials Limited ORG-100051097
|
Horsham, United Kingdom | Other |
| PPD Development LP ORG-100011560
|
Richmond, United States | Other, Laboratory analysis |
| TFS Trial Form Support AB ORG-100008755
|
Lund, Sweden | Other, Code 5 |
Locations
10 EU/EEA countries · 45 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 8 | 2 |
| Belgium | Ended | 1 | 1 |
| Croatia | Ended | 5 | 1 |
| Czechia | Ended | 7 | 1 |
| France | Ended | 39 | 11 |
| Germany | Ended | 12 | 6 |
| Hungary | Ended | 9 | 3 |
| Italy | Ended | 19 | 9 |
| Latvia | Ended | 2 | 1 |
| Spain | Ended | 24 | 10 |
| Rest of world
Argentina, Israel, Brazil, United States, Canada, Australia, Colombia
|
— | 154 | — |
Investigational sites
Medical University Of Vienna
Ophthalmology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
Ophthalmology, Neue Stiftingtalstrasse 6, 8010, Graz
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Ophthalmology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Selarl Centre Ophtalmologique Rabelais Imagerie Laser Et Reeducation De La Basse Vision
Ophthalmology, 2 Rue Antoine De Saint Exupery, 69002, Lyon
Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic
Ophthalmology, 113 Boulevard Saint Germain, 75006, Paris
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L.
Ophthalmology, 11 Rue Antoine Bourdelle, 75015, Paris
Hospices Civils De Lyon
Ophthalmology, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Retina
Ophthalmology, 6 Rue Therese Et Rene Planiol, 37540, Saint-Cyr-Sur-Loire
Centre Hospitalier Universitaire De Bordeaux
Ophthalmology, Place Amelie Raba Leon, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Ophthalmology, 2 Rue Ambroise Pare, 75010, Paris
Fondation A De Rothschild
Ophthalmology, 29 Rue Manin, 75019, Paris
Centre Hospitalier Intercommunal Creteil
Ophthalmology, 40 Avenue De Verdun, 94000, Creteil
Centre Monticelli Paradis D Ophtalmologie
Ophthalmology, 433 Rue Paradis, 13008, Marseille
Pole Vision Val D'Ouest
Ophthalmology, 39 Chemin De La Vernique, 69130, Ecully
Universitaetsklinikum Bonn AöR
Ophthalmology, Venusberg-Campus 1, Venusberg, Bonn
University Medical Center Hamburg-Eppendorf
Ophthalmology, Martinistrasse 52, Eppendorf, Hamburg
Augenzentrum Am St Franziskus-Hospital Muenster
Ophthalmologie, Hohenzollernring 74, Herz-Jesu, Munster
University Hospital Cologne AöR
Ophthalmology, Kerpener Strasse 62, Lindenthal, Cologne
Medizinische Hochschule Hannover
Ophthalmology, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Ludwig-Maximilians-Universitaet Muenchen
Ophthalmology, Mathildenstrasse 8, Ludwigsvorstadt-Isarvorstadt, Munich
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Ophtalmology, Maglodi Ut 89-91, Kerulet, Budapest
Semmelweis University
Ophtalmology, Maria Utca 39, 1085, Budapest Viii
Budapest Retina Associates Kft.
Ophtalmology, Vaci Ut 76, Kerulet, Budapest XIII
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oftalmologia, Via Sergio Pansini 5, 80131, Naples
University Hospital Of Ferrara
Oftalmologia, Cona, Via Aldo Moro 8, Ferrara
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Oftalmologia, Via Dei Vestini Snc, 66100, Chieti
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oftalmologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Oftalmologia, Viale Oxford 81, 00133, Rome
ASST Fatebenefratelli Sacco
Oftalmologia, Via Giovanni Battista Grassi 74, 20157, Milan
Ospedale San Raffaele S.r.l.
Oftalmologia, Via Olgettina 60, 20132, Milan
Careggi University Hospital
Oftalmologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Ophtalmology, Via Francesco Sforza 28, 20122, Milan
Bilboftal S.L.
Ophthalmology, Alameda De Recalde 49-51, 48010, Bilbao
Valles Ophthalmology Research S.L.
Ophthalmology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Institut Catala De Retina S.L.
Ophthalmology, Calle De La Pau Alcover 67, 08017, Barcelona
Instituto Oftalmologico Gomez-Ulla S.L.
Ophthalmology, Rua De Maruxa Mallo N 3, 15706, Santiago De Compostela
Hospital Universitario Rio Hortega
Ophthalmology, Calle Dulzaina 2, 47012, Valladolid
Metavision Arruzafa S.L.
Ophthalmology, Avenida De La Arruzafa 9, 14012, Cordoba
Hospital Clinico Universitario Lozano Blesa
Ophthalmology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Centro De Oftalmologia Barraquer S.A.
Ophthalmology, Calle Muntaner 314, 08021, Barcelona
Oftalmologia Vistahermosa S.L.
Ophthalmology, Avenida De La Ilustracion 1, Poligono Industrial De Burjassot, Burjassot
Hospital Universitario Puerta De Hierro De Majadahonda
Ophthalmology, Calle De Manuel De Falla 1, 28222, Majadahonda
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 | 2023-09-13 | 2025-04-10 | 2023-09-13 | 2023-10-12 | |
| Belgium | 2023-07-25 | 2025-02-11 | 2023-07-25 | 2023-07-25 | |
| Croatia | 2023-04-17 | 2025-01-20 | 2023-04-17 | 2023-08-30 | |
| Czechia | 2023-03-20 | 2024-12-17 | 2023-03-20 | 2023-07-18 | |
| France | 2023-01-11 | 2025-03-11 | 2023-01-11 | 2023-09-05 | |
| Germany | 2023-04-17 | 2025-02-26 | 2023-04-17 | 2023-09-26 | |
| Hungary | 2023-01-18 | 2025-02-07 | 2023-01-18 | 2023-09-13 | |
| Italy | 2023-05-03 | 2025-04-10 | 2023-05-03 | 2023-10-16 | |
| Latvia | 2023-05-23 | 2024-11-27 | 2023-05-23 | 2023-07-03 | |
| Spain | 2022-12-21 | 2025-02-11 | 2022-12-21 | 2023-09-19 |
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 |
|---|---|---|---|
| CTIS Summary of Results Submission for ISEE2009 SUM-125506
|
2026-03-26T11:45:06 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results | 2026-03-26T11:46:31 | Submitted | Laypersons Summary of Results |
Documents 72 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_CS | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_DE | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_ES | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_FR | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_HE | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_HR | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_HU | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_IT | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_PL | 1 |
| Laypersons summary of results (for publication) | ISEE2009-plain-lang-summary-disclosure_PT | 1 |
| Protocol (for publication) | D1 0101_ISEE2009_Protocol_2024-515185-13_en_fp | Am1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Placeholder_Document | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Placeholder_Document not required for transition trial | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Placeholder_Document not required for transition trials | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder_Document not required for transition trials | N/A |
| Recruitment arrangements (for publication) | K2_Procedures and Recruit Material_Placeholder Document not required for transition trial | NA |
| Recruitment arrangements (for publication) | K2_Procedures and Recruit Material_Placeholder Document not required for transition trial | NA |
| Recruitment arrangements (for publication) | K2_Procedures and Recruit Material_Placeholder Document not required for transition trial | NA |
| Recruitment arrangements (for publication) | K2_Procedures and Recruit Material_Placeholder_Document | NA |
| Recruitment arrangements (for publication) | K2_Procedures and Recruitment Material_Placeholder_Document not required for transition trials | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material description_Placeholder_Document not required for transition trials | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Placeholder_Document not required for transition trial | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Placeholder_Document not required for transition trial | N/A |
| Subject information and informed consent form (for publication) | L1_ICF_Participant_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnancy_FP | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FP | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant Privacy_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant_dut_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant_FP | 4-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant_fre_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregancy_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Privacy_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Baby_Data_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_dut_FP | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_FP | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_FP | 4-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_fre_FP | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Baby_data_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participant_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participant_FP | 4-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participant_lva_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participant_rus__FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_FP | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_lva_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_rus_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS_Participant_FP | 3-1 |
| Subject information and informed consent form (for publication) | L1_SIS_Pregnancy_FP | 2-1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_Placeholder_Document | NA |
| Subject information and informed consent form (for publication) | L2_Patient Card_Placeholder_Document not required for transition trials | NA |
| Subject information and informed consent form (for publication) | L2_Patient Card_Placeholder_Document not required for transition trials | NA |
| Subject information and informed consent form (for publication) | L2_Patient Card_Placeholder_Document not required for transition trials | NA |
| Subject information and informed consent form (for publication) | L2_Patient Card_Placeholder_Document not required for transition trials | NA |
| Summary of results (for publication) | CTIS Results Submission for ISEE2009 | 1 |
| Synopsis of the protocol (for publication) | D1 0201_ISEE2009_ProtocolSynopsis_2024-515185-13_AT_de_fp | Am1 |
| Synopsis of the protocol (for publication) | D1 0202_ISEE2009_ProtocolSynopsis_2024-515185-13_BE_fr_fp | Am1 |
| Synopsis of the protocol (for publication) | D1 0203_ISEE2009_ProtocolSynopsis_2024-515185-13_FR_fr_fp | Am1 |
| Synopsis of the protocol (for publication) | D1 0204_ISEE2009_ProtocolSynopsis_2024-515185-13_HU_hu_fp | Am1 |
| Synopsis of the protocol (for publication) | D1 0205_ISEE2009_ProtocolSynopsis_2024-515185-13_IT_it_fp | Am1 |
| Synopsis of the protocol (for publication) | D1 0206_ISEE2009_ProtocolSynopsis_2024-515185-13_ES_es_fp | Am1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-29 | Austria | Acceptable 2024-10-09
|
2024-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Acceptable | 2025-02-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Austria | Acceptable | 2025-03-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Acceptable | 2025-03-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-20 | Acceptable | 2025-02-20 |