Study to evaluate the long-term safety of GT005 in participants having macular degeneration that led to geographic atrophy in their eyes and that have been previously treated in a prior Gyroscope study using the same product.

Start 8 Dec 2022 · Status Ongoing, recruitment ended · 4 EU/EEA countries · 8 sites · Protocol CPPY988A12203B

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruitment ended

Participants planned 163

Countries 4

Sites 8

Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in participants already treated with GT005 in the previous studies GT005-01 (FOCUS), GT005-02 (EXPLORE) and GT005-03 (HORIZON).

The overall objectives of the study are to evaluate the long-term safety of GT005 in participants with geographic atrophy secondary to age-related macular degeneration who have been treated in an antecedent study. The primary endpoint of this study (GTORACLE) is to evaluate the long-term safety of GT005 for up to 5 yea…

Key facts

Sponsor: Novartis Pharma AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trial duration: 8 Dec 2022 → ongoing
Decision date (initial): 2024-05-06
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Novartis Pharma AG

External identifiers

EU CT number: 2024-510946-15-00
EudraCT number: 2020-003987-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

Conditions and MedDRA coding

Version	Level	Code	Term	System organ class
20.0	LLT	10075719	Atrophic age-related macular degeneration	10015919

Regulatory references

Scientific advice from competent authorities: Medicines And Healthcare Products Regulatory Agency, Medicines Evaluation Board, Paul-Ehrlich-Institut
Plan to share IPD: Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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

Exclusion criteria 1

Not applicable

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Incidence and severity of ocular and systemic Adverse Events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

PPY988A

PRD9979193 · Product

Active substance: GT005
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: SUBRETINAL USE
Authorisation status: Not Authorised
MA holder: GYROSCOPE THERAPEUTICS LTD
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation: Novartis Pharma AG
Address: Lichtstrasse 35
City: Basel
Postcode: 4056
Country: Switzerland

Scientific contact point

Organisation: Gyroscope Therapeutics Limited
Contact name: Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation: Gyroscope Therapeutics Limited
Contact name: Novartis Pharma Arzneimittel GmbH

Third parties 14

Organisation	City, country	Duties
Accovion Sp. z o.o. ORG-100047041	Cracow, Poland	On site monitoring, Code 12
Bioagilytix Labs LLC ORG-100013030	Durham, United States	Other
Accovion S.L. ORG-100042172	Madrid, Spain	On site monitoring, Code 12
Eurofins Central Laboratory B.V. ORG-100036990	Breda, Netherlands	Other, Laboratory analysis
Boston Image Reading Center LLC ORG-100046514	Boston, United States	Other
Parexel International (IRL) Limited ORG-100022780	Dublin 2, Ireland	Code 12
Clinipace Inc. ORG-100042162	Raleigh, United States	On site monitoring, Code 10, Code 12, Other, Code 5, Data management, E-data capture
United Language Group Inc. ORG-100047361	Minneapolis, United States	Other
Medidata Solutions Inc. ORG-100016256	New York, United States	E-data capture
Clinipace GmbH ORG-100008285	Eschborn, Germany	On site monitoring, Code 12
Global Eye Trials Ltd. ORG-100051097	Horsham, United Kingdom	Other
Accovion ORG-100029670	Lyon, France	On site monitoring, Code 12
Scout Clinical ORG-100042228	Dallas, United States	Other
Accovion GmbH ORG-100031977	Eschborn, Germany	On site monitoring, Code 5

Locations

4 EU/EEA countries · 8 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruitment ended	5	2
Germany	Ongoing, recruitment ended	10	2
Poland	Ongoing, recruitment ended	4	1
Spain	Ongoing, recruitment ended	11	3
Rest of world Australia, United States, United Kingdom	—	133	—

Investigational sites

France

2 sites · Ongoing, recruitment ended

Centre Hospitalier Universitaire De Dijon

Service Ophtalmologie, 14 Rue Paul Gaffarel, 21000, Dijon

Centre Hospitalier Universitaire De Nantes

Service Ophtalmologie, 1 Place Alexis Ricordeau, 44000, Nantes

Germany

2 sites · Ongoing, recruitment ended

Universitaetsklinikum Tuebingen AöR

Universitäts-Augenklinik, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen

Universitaetsklinikum Schleswig-Holstein AöR

Klinik für Augenheilkunde, Ratzeburger Allee 160, 23538, Luebeck

Poland

1 site · Ongoing, recruitment ended

Oftalmika Sp. z o.o.

., Ul. Modrzewiowa 15, 85-631, Bydgoszcz

Spain

3 sites · Ongoing, recruitment ended

Instituto De Microcirugia Ocular Dos S.L.

Retina, Calle De Josep Maria Llado 3, 08017, Barcelona

Clinica Baviera S.A.

Retina, Paseo De La Castellana 20, 28046, Madrid

Clinica Universidad De Navarra

Ophtalmology, Avenue Pio XII 36, 31008, Pamplona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start	Recruitment end
France	2023-08-08	2023-08-09	2023-10-02
Germany	2022-12-08	2022-12-09	2024-03-05
Poland	2024-03-22	2024-03-26	2024-03-29
Spain	2023-05-03	2023-05-08	2024-03-18

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol - Signature Page_2024-510946-15-00_1_English_Red	5.0
Protocol (for publication)	D1_Protocol_2024-510946-15-00_1_English_Red	5.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	NA
Recruitment arrangements (for publication)	K1_Recruitment arrangements	N/A
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_Redacted	5.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_Redacted	5.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Newborn Child	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Patient Reimbursement_Redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Patient Reimbursement_Redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Reimbursement Expenses	2.1
Subject information and informed consent form (for publication)	L2_Other subject information material description Reimbursement Brochure	2.1
Subject information and informed consent form (for publication)	L2_Other subject information material description Reimbursement Email	2.1
Subject information and informed consent form (for publication)	L2_Other subject information material description Reimbursement Pass	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material description Reimbursement Pass Reloadable	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Scout Brochure	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Scout Email Communication	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Scout Pass	N/A
Subject information and informed consent form (for publication)	L2_Other subject information material_ScoutPass Reloadable	1.0
Synopsis of the protocol (for publication)	D1_Protocol Summary in Lay Language_2024-510946-15-00_1_French_NonRed	5.0
Synopsis of the protocol (for publication)	D1_Protocol Summary in Lay Language_2024-510946-15-00_1_Polish_NonRed	5.0
Synopsis of the protocol (for publication)	D1_Protocol Summary in Lay Language_2024-510946-15-00_1_Spanish_NonRed	5.0

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-03-20	Poland	Acceptable 2024-04-29	2024-04-29
2	SUBSTANTIAL MODIFICATION	SM-1	2024-07-31	Poland	Acceptable 2024-09-30	2024-10-02
3	SUBSTANTIAL MODIFICATION	SM-2	2024-11-19	Poland	Acceptable 2025-01-17	2025-01-17
4	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-04-02	Poland	Acceptable 2025-01-17	2025-04-02
5	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-04-23	Poland	Acceptable 2025-01-17	2025-04-23