Clinical trial • Phase II • Ophthalmology

GT005 for Geographic atrophy secondary to age-related macular degeneration

Phase II trial of GT005 for Geographic atrophy secondary to age-related macular degeneration. None/Not specified-controlled. 133 participants.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Geographic atrophy secondary to age-related macular degeneration
Trial Stage
Phase II
Drug Modality
Gene therapy

Key dates

Initial CTIS Submission Date
20-03-2024
First CTIS Authorization Date
29-04-2024

Trial design

None/Not specified-controlled Phase II trial across 8 sites in Spain, Germany, France and others.

Comparator
None/Not specified
Target Sample Size
133
Trial Duration For Participant
1825

Eligibility

Recruits 133 No vulnerable population selected; participants must be able and willing to give written informed consent. No assent procedures specified..

Vulnerable Population
No vulnerable population selected; participants must be able and willing to give written informed consent. No assent procedures specified.

Inclusion criteria

  • {"criterion_text":"- Able and willing to give written informed consent\n- Received GT005 in an antecedent study, GT005-01 (FOCUS, NCT03846193), GT005-02 (EXPLORE, NCT04437368 and GT005-03 (HORIZON, NCT04566445)\n- Willing to attend study visits and complete the study assessments"}

Exclusion criteria

  • {"criterion_text":"- Not applicable"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence and severity of ocular and systemic Adverse Events","definition_or_measurement_approach":"The primary endpoint is to evaluate the long-term safety of GT005 for up to 5 years post-treatment, evaluating the incidence and severity of ocular and systemic adverse events (AEs)."}

Recruitment

Digital Remote Recruitment
True, evidence: 'Scout Email Communication' and other Scout digital materials are included among subject information materials indicating email/digital communication methods.
Planned Sample Size
133
Recruitment Window Months
80
Consent Approach
Participants must be 'Able and willing to give written informed consent'. Subject information and informed consent forms (L1/L2) are provided; separate ICF documents exist for Pregnant Partner and Newborn Child and reimbursement information. Protocol summaries are available in Spanish, French and Polish, and country-specific SIS/ICF documents are present for Spain, Germany, France and Poland.

Methods

  • Country-specific recruitment arrangements documents present (K1_Recruitment arrangements) for Spain (associatedEntityId 127257), Germany (associatedEntityId 181343), France (associatedEntityId 181342) and Poland (associatedEntityId 181344).
  • Patient Concierge – travel & expense (Scout Clinical) - support for patient travel and expenses (explicitly listed as 'Patient Concierge – travel & expense').
  • Scout outreach materials: Scout Brochure; Scout Pass; Scout Email Communication; ScoutPass Reloadable (document titles present indicating brochure/pass/email materials used for participant engagement).
  • Subject information and informed consent forms and related materials (multiple L1/L2 documents) available per country.

Geography

Total Number Of Sites
8
Total Number Of Participants
30

Spain

Latest Decision Or Authorization Date
03-10-2024
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Clinica Baviera S.A.
Department Name
Retina
Principal Investigator Name
Marta Suarez de Figueroa Diez
Principal Investigator Email
Figueroa.Marta@outlook.es
Contact Person Name
Marta Suarez de Figueroa Diez
Contact Person Email
Figueroa.Marta@outlook.es
Site Name
Clinica Universidad De Navarra
Department Name
Ophtalmology
Principal Investigator Name
Alfredo García Layana
Principal Investigator Email
aglayana@unav.es
Contact Person Name
Alfredo García Layana
Contact Person Email
aglayana@unav.es
Site Name
Instituto De Microcirugia Ocular Dos S.L.
Department Name
Retina
Principal Investigator Name
Rafael Navarro Alemany
Principal Investigator Email
navarro@imo.es
Contact Person Name
Rafael Navarro Alemany
Contact Person Email
navarro@imo.es

Germany

Latest Decision Or Authorization Date
02-04-2025
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitäts-Augenklinik
Principal Investigator Name
Karl Ulrich Bartz-Schmidt
Principal Investigator Email
studien.augenklinik@med.uni-tuebingen.de
Contact Person Name
Karl Ulrich Bartz-Schmidt
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Augenheilkunde
Principal Investigator Name
Salvatore Grisanti
Principal Investigator Email
Salvatore.Grisanti@uksh.de
Contact Person Name
Salvatore Grisanti
Contact Person Email
Salvatore.Grisanti@uksh.de

France

Latest Decision Or Authorization Date
02-04-2025
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service Ophtalmologie
Principal Investigator Name
Catherine Creuzot-Garcher
Principal Investigator Email
catherine.creuzot-garcher@chu-dijon.fr
Contact Person Name
Catherine Creuzot-Garcher
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service Ophtalmologie
Principal Investigator Name
Jean-Baptiste Ducloyer
Principal Investigator Email
jeanbaptiste.ducloyer@chu-nantes.fr
Contact Person Name
Jean-Baptiste Ducloyer

Poland

Latest Decision Or Authorization Date
02-04-2025
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Oftalmika Sp. z o.o.
Department Name
.
Principal Investigator Name
Bartłomiej Kałużny
Principal Investigator Email
clinicaltrials@oftalmika.pl
Contact Person Name
Bartłomiej Kałużny
Contact Person Email
clinicaltrials@oftalmika.pl

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Clinipace Inc.
Responsibilities
Codes: 1, 10, 12, 15 (Reporting, payment to sites, safety notifications to sites/investigators), 5, 6, 7
Name
Clinipace GmbH
Responsibilities
Codes: 1, 12
Name
Parexel International (IRL) Limited
Responsibilities
Code: 12

Third parties

  • {"country":"Poland","full_name":"Accovion Sp. z o.o.","duties_or_roles":"Codes: 1, 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Exploratory Immunogenicity Analyses","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Accovion S.L.","duties_or_roles":"Codes: 1, 12","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Primary Central Laboratory (analysis of Biochemistry and Hematology); code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Boston Image Reading Center LLC","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Code: 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"Codes: 1, 10, 12, 15 (Reporting, payment to sites, safety notifications to sites/investigators), 5, 6, 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"United Language Group Inc.","duties_or_roles":"Language (Translation) Services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clinipace GmbH","duties_or_roles":"Codes: 1, 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Global Eye Trials Ltd.","duties_or_roles":"Visual Acuity and Refraction certification","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Accovion","duties_or_roles":"Codes: 1, 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Concierge – travel & expense","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Accovion GmbH","duties_or_roles":"Codes: 1, 5","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PPY988A
Active Substance
GT005
Modality
Gene therapy
Routes Of Administration
SUBRETINAL USE
Route
SUBRETINAL
Authorisation Status
N/A, since no IMP is administered in this trial

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