Clinical Trials Register

Summary
EudraCT Number:	2018-002152-32
Sponsor's Protocol Code Number:	GR40306
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-002152-32

A.3

Full title of the trial

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA)

STUDIO DI FASE III, MULTICENTRICO, RANDOMIZZATO, CON DOPPIO MASCHERAMENTO, CONTROLLATO CON PRINCIPIO ATTIVO, VOLTO A VALUTARE L’EFFICACIA E LA SICUREZZA DI
FARICIMAB IN PAZIENTI AFFETTI DA DEGENERAZIONE MACULARE NEOVASCOLARE CORRELATA ALL’ETÀ (TENAYA)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (Tenaya)

Studio volto a valutare l'efficacia e la sicurezza di faricimab in pazienti affetti da degenerazione maculare neovascolare correlata all'età (TENAYA)

A.3.2

Name or abbreviated title of the trial where available

TENAYA

A.4.1

Sponsor's protocol code number

GR40306

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	F.Hoffmann La-Roche Ltd - Basel
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche LTD
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	global.rochegenentechtrials@roche.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Faricimab
D.3.2	Product code	[RO6867461/F06]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1607793-29-2
D.3.9.2	Current sponsor code	RO6867461
D.3.9.3	Other descriptive name	VA2, VEGF-Ang2 ophtha Humanized anti-VEGF-A anti-Ang-2 bispecific Antibody
D.3.9.4	EV Substance Code	SUB126170
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Eylea
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer AG - AIC: EU/1/12/797/002
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Aflibercept
D.3.2	Product code	[N.A.]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AFLIBERCEPT
D.3.9.1	CAS number	862111-32-8
D.3.9.2	Current sponsor code	Ro 717-1571
D.3.9.4	EV Substance Code	SUB26987
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Neovascular age-related macular degeneration

Degenerazione maculare neovascolare correlata all’età

E.1.1.1

Medical condition in easily understood language

Neovascular Age-related macular degeneration (nAMD), also known as wet AMD, is a medical condition which may result in distortion and potentially irreversible loss of the central vision

Degenerazione maculare neovascolare correlata all’età (nAMD), nota anche come AMD, è una condizione medica che può causare distorsioni e perdita potenzialmente irreversibile della vista

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10071129
E.1.2	Term	Neovascular age-related macular degeneration
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

• To evaluate the efficacy of IVT (intravitreal) injections of faricimab on change in best-corrected visual acuity (BCVA)

• Valutare l’efficacia di iniezioni intravitreali (IVT) di faricimab sugli esiti di BCVA

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of faricimab on additional BCVA outcomes
• To evaluate the frequency of study drug administration
• To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT) and fundus fluorescein angiography (FFA)
• To evaluate the ocular and non-ocular safety and tolerability of faricimab
• To characterize the systemic pharmacokinetics of faricimab
• To evaluate the immune response to faricimab
• To evaluate potential effects of anti-drug antibody (ADA)s

• Valutare l’efficacia di faricimab su ulteriori esiti di BCVA
• Valutare la frequenza della somministrazione del farmaco in studio
• Valutare l’efficacia di faricimab in termini di misure anatomiche valutate con OCT ed in termini di misure anatomiche valutate con FFA
• Valutare la sicurezza oculare e non oculare e la tollerabilità di faricimab
• Caratterizzare la farmacocinetica sistemica di faricimab
• Valutare la risposta immunitaria a faricimab
• Valutare i potenziali effetti degli ADA

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age >= 50 years
- Ability to comply with the study protocol
- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment
- Treatment-naïve choroidal neovascularization (CNV) secondary to AMD (nAMD) in the study eye
- BCVA of 20/32 to 20/320 (letter score of 78 to 24) in the study eye at the initiation of treatment

- Età >= 50 anni
- Capacità di rispettare il protocollo dello studio
- Per le donne potenzialmente fertili: consenso a praticare l’astinenza (astenersi dai rapporti
eterosessuali) o a utilizzare metodi contraccettivi accettabili durante il periodo di trattamento e per almeno 3 mesi dopo l’ultima dose del trattamento dello studio.
- CNV naïve al trattamento secondaria ad AMD (nAMD)
- BCVA di 78-24 lettere incluse (da 20/32 a 20/320 circa equivalenti di Snellen) al test iniziale a una distanza di 4 metri il Giorno 1

E.4

Principal exclusion criteria

- Uncontrolled blood pressure
- Pregnancy or breastfeeding, or intention to become pregnant during the study
- CNV due to causes other than AMD in the study eye
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- Presence at screening of central serous chorioretinopathy in the study eye
- Retinal pigment epithelial tear involving the macula on Day 1 in the study eye
- On FFA/ Color fundus photograph:
o Subretinal hemorrhage of > 50% of the total lesion area and/or that involves the fovea
o Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- Current vitreous hemorrhage on Day 1 in the study eye
- Uncontrolled glaucoma in the study eye
- Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
- Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy in the study eye within 3 months prior to Day 1
- Any other intraocular surgery in the study eye
- Prior periocular pharmacological or IVT treatment for other retinal diseases in the study eye
- Prior IVT administration of faricimab in either eye
- Active ocular inflammation or suspected or active ocular or periocular infection in either eye

- Pressione arteriosa non controllata
- Gravidanza, allattamento o pianificazione di una gravidanza durante lo studio
- CNV imputabile a cause diverse dalla AMD
- Anamnesi di qualsiasi patologia maculare non correlata ad AMD che influenzi la vista o
contribuisca alla presenza di fluido intraretinico o sottoretinico
- Presenza allo screening di corioretinopatia sierosa centrale
- Lacerazione dell’epitelio del pigmento retinico che coinvolga la macula il Giorno 1
- All’esame FFA/CFP:
- Emorragia sottoretinica che interessi > 50% dell’area totale della lesione e/o che
coinvolga la fovea
- Fibrosi o atrofia che interessi ¿ 50% dell’area totale della lesione e/o che coinvolga la
fovea
- Qualsiasi patologia intraoculare concomitante che secondo il giudizio dello sperimentatore, potrebbe ridurre il potenziale miglioramento della vista o richiedere un intervento medico o chirurgico durante lo studio
- Emorragia del vitreo in atto il Giorno 1
- Glaucoma non controllato
- Equivalente sferico di errore refrattivo che dimostri più di 8 diottrie di miopia
- Qualsiasi trattamento precedente o concomitante per CNV o anomalie dell’interfaccia vitreomaculare
- Qualsiasi intervento di chirurgia della cataratta o trattamento per complicanze di un intervento di chirurgia della cataratta con steroidi o capsulotomia con laser YAG nei 3 mesi precedenti il Giorno 1
- Qualsiasi altro intervento chirurgico intraoculare
- Precedente trattamento perioculare farmacologico o IVT per altrepatologie della retina
- Precedente somministrazione IVT di faricimab in uno dei due occhi
- Infiammazione oculare attiva o infezione oculare o perioculare sospetta o attiva in uno dei due occhi

E.5 End points

E.5.1

Primary end point(s)

1. Change in BCVA from baseline to average at Weeks 40, 44 and 48

1. Variazione della BCVA dal basale alla media rilevata alle Settimane 40, 44 e 48

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Baseline (Day 1), Weeks 40, 44, and 48

1. Basale (giorno 1), Settimane 40, 44 e 48

E.5.2

Secondary end point(s)

11. Proportion of patients with absence of intraretinal fluid over time; 12. Proportion of patients with absence of subretinal fluid over time; 13. Proportion of patients with absence of intraretinal and subretinal fluid over time; 14. Proportion of patients with absence of intraretinal cysts over time; 15. Proportion of patients with absence of pigment epithelium detachment over time; 16. Change from baseline in total area of CNV lesion at Week 48 and Week 112; 17. Change from baseline in total area of leakage at Week 48 and Week 112; 18. Incidence and severity of ocular adverse events; 19. Incidence and severity of non-ocular adverse events; 20. Plasma concentration of faricimab over time; 21. Presence of ADAs during the study relative to the presence of ADAs at baseline; 22. Relationship between ADA status and efficacy, safety, or pharmacokinetic endpoints; 1. Change from baseline in BCVA over time; 2. Proportion of patients gaining >= 15, >= 10, >= 5, or >= 0 letters in BCVA from baseline over time; 3. Proportion of patients avoiding loss of >= 15, >= 10, >=5, or >= 0 letters in BCVA from baseline over time; 4. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time; 5. Proportion of patients gaining >= 15 letters or achieving BCVA of >=84 letters over time; 6. Proportion of patients with BCVA Snellen equivalent of 20/200 or
worse over time; 7. Proportion of patients on different treatment intervals at Weeks 48,
60, and 112; 8. Number of study drug injections received through Weeks 48, 60, and 112; 9. Change from baseline in CST based on an average at Weeks 40, 44, and 48; 10. Change from baseline in CST over time

11. Percentuale di pazienti con assenza di fluido intraretinico nel corso del tempo; 12. Percentuale di pazienti con assenza di fluido sottoretinico nel corso del tempo; 13. Percentuale di pazienti con assenza di fluido intraretinico e sottoretinico nel corso del tempo; 14. Percentuale di pazienti con assenza di cisti intraretiniche nel corso del tempo; 15. Percentuale di pazienti con assenza di distacco dell’epitelio pigmentato nel corso del tempo; 16. Variazione rispetto al basale dell’area totale della lesione CNV alla Settimana 48 e alla Settimana 112; 17. Variazione rispetto al basale dell’area totale dello stravaso da CNV alla Settimana 48 e alla Settimana 112; 18. Incidenza e gravità degli eventi avversi oculari; 19. Incidenza e gravità degli eventi avversi non oculari; 20. Concentrazione plasmatica di faricimab nel corso del tempo; 21. Presenza di ADA nel corso dello studio rispetto alla presenza di ADA al basale; 22. Rapporto tra stato degli ADA ed endpoint di efficacia, sicurezza o PK; 1. Variazione della BCVA nel corso del tempo rispetto al basale; 2. Percentuale di pazienti che guadagnano >= 15, >= 10, >= 5 o >= 0 lettere nella BCVA nel corso del tempo rispetto al basale; 3. Percentuale di pazienti che evitano la perdita di >= 15, >= 10, >=5, o >= 0 lettere nella BCVA nel corso del tempo rispetto al basale; 4. Percentuale di pazienti con un equivalente Snellen della BCVA di 20/40 o migliore nel corso del tempo; 5. Percentuale di pazienti che guadagnano >=15 lettere o una BCVA >=84 lettere nel corso del tempo; 6. Percentuale di pazienti con un equivalente Snellen della BCVA di 20/200 o peggiore nel corso del tempo; 7. Percentuale di pazienti in terapia a intervalli di somministrazione alle
Settimane 48, 60 e 112; 8. Numero di iniezioni di farmaco in studio ricevute fino alle Settimane 48, 60 e 112; 9.Variazione rispetto al basale dello spessore retinico centrale (CST) sulla base della media rilevata alle Settimane 40, 44 e 48; 10. Variazione del CST nel corso del tempo rispetto al basale

E.5.2.1

Timepoint(s) of evaluation of this end point

11. Baseline to Week 112; 12. Baseline to Week 112; 13. Baseline to Week 112; 14. Baseline to Week 112; 15. Baseline to Week 112; 16. Baseline, Week 48 and 112; 17. Baseline, Week 48 and 112; 18. Up to Week 112; 19. Up to Week 112; 20. Week 1, 4, 16, 20, 48, 76, 112; 21. Week 1, 4, 20, 48, 76, 112; 22. Week 1, 4, 20, 48, 76, 112; 1. Baseline to Week 112; 2. Baseline to Week 112; 3. Baseline to Week 112; 4. Baseline to Week 112; 5. Baseline to Week 112; 6. Baseline to Week 112; 7. Week 48, 60, and 112; 8. Week 48, 60, and 112; 9. Baseline to Week 112; 10. Baseline to Week 112

11. Dal basale alla settimana 112; 12. Dal basale alla settimana 112; 13. Dal basale alla settimana 112; 14. Dal basale alla settimana 112; 15. Dal basale alla settimana 112; 16. Basale, settimane 48 e 112; 17. Basale, settimane 48 e 112; 18. Fino alla settimana 112; 19. Fino alla settimana 112; 20. Settiamne 1, 4, 16, 20, 48, 76 e 112; 21. Settimane 1,4, 20, 48, 76, 112; 22. Settimane 1,4, 20, 48, 76, 112; 1. Dal basale alla settimana 112; 2. Dal basale alla settimana 112; 3. Dal basale alla settimana 112; 4. Dal basale alla settimana 112; 5. Dal basale alla settimana 112; 6. Dal basale alla settimana 112; 7. Settimane 48, 60 e 112; 8. Settimane 48, 60 e 112; 9. Dal basale alla settimana 112; 10. Dal basale alla settimana 112

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity, Biomarker

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Brazil

Canada

Israel

Japan

Mexico

Russian Federation

Turkey

United States

Germany

Hungary

Italy

Netherlands

Poland

Spain

Switzerland

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

165

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

475

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

130

F.4.2.2

In the whole clinical trial

640

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

A patient will be eligible to receive Roche IMP (faricimab) after completing the study if all of the following conditions are met:
• The patient has a sight-threatening or severe medical condition and requires continued Roche IMP treatment for his or her well-being
• There are no appropriate alternative treatments available to the patient
• The patient and his or her doctor comply with and satisfy any legal or regulatory requirements that apply to them

Il paziente sarà idoneo a ricevere il trattamento con il faricimab dopo la fine dello studio stesso se saranno soddisfatte tutte le seguenti condizioni:
• Se il paziente soffre di una malattia grave o che può mettere a rischio la sua vita e richiede un trattamento continuato con il medicinale dello studio;
• Non esistono trattamenti alternativi appropriati disponibili;
• Se il paziente e il medico dello studio si impegnano a rispettare i requisiti legali e normativi applicabili.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-04-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-07

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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