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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
Date last updated
12/07/2024

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:
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
NA
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
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United States of America
State/province [5] 0 0
Hawaii
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United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Nevada
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United States of America
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New York
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North Carolina
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Oregon
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United States of America
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Pennsylvania
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South Carolina
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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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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France
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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
Country [70] 0 0
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

No information has been provided regarding IPD availability


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