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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05536297




Registration number
NCT05536297
Ethics application status
Date submitted
7/09/2022
Date registered
10/09/2022

Titles & IDs
Public title
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
Scientific title
An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)
Secondary ID [1] 0 0
2022-002860-59
Secondary ID [2] 0 0
ISEE2009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - avacincaptad pegol

Experimental: avacincaptad pegol - Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.


Treatment: Drugs: avacincaptad pegol
Intravitreal Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 18 Months
Secondary outcome [1] 0 0
Number of participants with Anti-Drug Antibody (ADA) status
Timepoint [1] 0 0
Up to 18 Months
Secondary outcome [2] 0 0
Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration
Timepoint [2] 0 0
Up to 18 Months

Eligibility
Key inclusion criteria
* 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.
* Patient must provide new written informed consent for this OLE trial prior to participation.
* Patient must have the ability to return for all trial visits for the duration of the 18-month trial.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham),
* Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.
* Patient did not enroll into this OLE trial within the 90 day enrollment period.
* Patient who is pregnant or nursing

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
278
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [2] 0 0
Sydney Retina Clinic - Sydney
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Nevada
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Washington
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Argentina
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Sante Fe
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Austria
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Styria
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Austria
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Tyrol
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Austria
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Vienna
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Belgium
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Brussels
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Brazil
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Belo Horizonte
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Ontario
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Colombia
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Bogota
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Colombia
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Medellin
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Croatia
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Osijek
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Czechia
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Smíchov
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France
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Bordeaux
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France
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Créteil
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France
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Ecully
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France
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Lyon
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Marseille
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France
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Paris
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France
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Saint Cyr sur Loire
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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München
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Germany
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Münster
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Hungary
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Budapest
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Rehovot
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Israel
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Tzrifin
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Italy
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Bologna
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Italy
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Chieti
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Italy
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Ferrara
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Italy
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Milano
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Italy
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Napoli
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Italy
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Roma
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Italy
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Torrette Di Ancona
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Latvia
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Riga
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Cordoba
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Spain
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Sant Cugat del Valles
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Spain
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Valladolid
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Spain
State/province [70] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05536297