Clinical Trials Register

Summary
EudraCT Number:	2018-000286-36
Sponsor's Protocol Code Number:	LEVODESA_04-2017
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-06-21
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

Spain - AEMPS

A.2

EudraCT number

2018-000286-36

A.3

Full title of the trial

An international, multicenter, randomized, blinded-assessor, parallel-group clinical study comparing eye drops of combined LEvofloxAcin + DExamethasone foR 7 days followed by dexamethasone alone for an additional 7 days vs. tobramycin + dexamethasone for 14 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults – LEADER 7.

Estudio clínico internacional, multicéntrico, aleatorizado, enmascarado para el evaluador y de grupos paralelos para comparar un colirio combinado de levofloxacino + dexametasona durante 7 días, seguido de dexametasona sola durante otros 7 días frente a tobramicina + dexametasona durante 14 días para prevenir y tratarla prevención y el tratamiento de la inflamación y evitar la prevención de la infección asociadas a la operación de cataratas en adultos - LEADER 7

A.3.1

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

Clinical study comparing eye drops of combined LEvofloxAcin + DExamethasone foR 7 days followed by dexamethasone alone for an additional 7 days vs. tobramycin + dexamethasone for 14 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults.

Estudio clínico para comparar un colirio combinado de LEvofloxAcino + DExametasona durante 7 días, seguido de dexametasona sola durante 7 días adicionales frente a tobramicina + dexametasona durante 14 días para la prevención y el tratamiento de la inflamación y la prevención de la infección asociada a la cirugía de catarata en adultos.

A.3.2

Name or abbreviated title of the trial where available

LEADER 7

A.4.1

Sponsor's protocol code number

LEVODESA_04-2017

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	NTC s.r.l.
B.1.3.4	Country	Italy
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	NTC s.r.l.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	OPIS s.r.l.
B.5.2	Functional name of contact point	Dipartimento Medico
B.5.3	Address:
B.5.3.1	Street Address	Palazzo Aliprandi, Via Matteotti 10
B.5.3.2	Town/ city	Desio (MB)
B.5.3.3	Post code	20832
B.5.3.4	Country	Italy
B.5.4	Telephone number	+3903626331
B.5.5	Fax number	+390362633633
B.5.6	E-mail	osservatorio@opis.it

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	levofloxacin+dexamethasone
D.3.2	Product code	levofloxacin+dexamethasone
D.3.4	Pharmaceutical form	Eye drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOFLOXACIN
D.3.9.1	CAS number	100986-85-4
D.3.9.4	EV Substance Code	SUB08471MIG
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.2	Current sponsor code	DEXAMETHASONE
D.3.9.3	Other descriptive name	DEXAMETHASONE
D.3.9.4	EV Substance Code	SUB07017MIG
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	Yes
D.2.1.1.1	Trade name	Maxidex
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Laboratories (UK) Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Eye drops, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.2	Current sponsor code	DEXAMETHASONE
D.3.9.3	Other descriptive name	DEXAMETHASONE
D.3.9.4	EV Substance Code	SUB07017MIG
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 3
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	Tobradex
D.2.1.1.2	Name of the Marketing Authorisation holder	ALCON-COUVREUR S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Eye drops, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TOBRAMYCIN
D.3.9.2	Current sponsor code	TOBRAMYCIN
D.3.9.3	Other descriptive name	TOBRAMYCIN
D.3.9.4	EV Substance Code	SUB11134MIG
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	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.2	Current sponsor code	DEXAMETHASONE
D.3.9.3	Other descriptive name	DEXAMETHASONE
D.3.9.4	EV Substance Code	SUB07017MIG
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Prevention and treatment of inflammation and prevention of infection associated with cataract surgery

Prevención y tratamiento de la inflamación y prevención de la infección asociadas a la operación de cataratas

E.1.1.1

Medical condition in easily understood language

Prevention and treatment of inflammation and prevention of infection associated with cataract surgery

Prevención y tratamiento de la inflamación y prevención de la infección asociadas a la operación de cataratas

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	10007739
E.1.2	Term	Cataract
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

Efficacy: To demonstrate the non-inferiority of combined levofloxacin + dexamethasone eye drops for 7 days followed by dexamethasone eye drops alone for an additional 7 days vs. standard treatment tobramycin + dexamethasone eye drops for 14 days in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

Eficacia: demostrar la no inferioridad de un colirio combinado de levofloxacino + dexametasona durante 7 días, seguido de un colirio de dexametasona sola durante otros 7 días frente al tratamiento estándar con colirio de tobramicina + dexametasona durante 14 días para prevenir y tratar la inflamación ocular postoperatoria y evitar la infección.

E.2.2

Secondary objectives of the trial

Safety and tolerability: To evaluate the safety of combined levofloxacin + dexamethasone eye drops; To evaluate the tolerability of combined levofloxacin – dexamethasone eye drops.

Compliance: To evaluate compliance with prescribed treatment.

Seguridad y tolerabilidad:
· Evaluar la seguridad de un colirio combinado de levofloxacino + dexametasona.
· Evaluar la tolerabilidad de un colirio combinado de levofloxacino + dexametasona.

Cumplimiento terapéutico: Evaluar el cumplimiento terapéutico del tratamiento recetado.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed written informed consent must be obtained before any assessment is performed
2. Male or female, age ≥40 years
3. Senile or presenile uncomplicated cataract surgery
4. Willing to interrupt the use of contact lenses for the entire duration of the study
5. Able and willing to follow study procedures
6. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception, which include an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.

1. Deberá obtenerse el consentimiento informado por escrito firmado antes de realizar ninguna evaluación.
2. Hombres o mujeres de edad ≥ 40 años.
3. Operación de cataratas seniles y preseniles sin complicaciones.
4. Disposición a interrumpir el uso de lentes de contacto mientras dure el estudio.
5. Capacidad y disposición para seguir los procedimientos del estudio.
6. Las mujeres deben ser posmenopáusicas (24 meses de amenorrea), quirúrgicamente estériles o deben aceptar utilizar un método anticonceptivo eficaz, que incluye una terapia hormonal establecida o un dispositivo intrauterino para mujeres, y el uso de un anticonceptivo de barrera (es decir, diafragma o condones) con espermicida.

E.4

Principal exclusion criteria

1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations (e.g. ocular herpes, blepharitis, conjunctivitis, uveitis, keratitis, diabetic retinopathy, retinal vein occlusions, retinal vasculitis, retinal angiomatous proliferation, pseudoexfoliation syndrome, intraoperative floppy iris syndrome, etc.)
2. Patients undergoing bilateral cataract surgery
3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-VEGF (vascular endothelial growth factor) drugs
4. Systemic diseases that may interfere with the results of the study (e.g. rheumatoid arthritis, Sjögren's syndrome, Behçet's disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.)
5. Any condition that could interfere with correct instillation of eye drops
6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
7. Monocular patients
8. Visual Acuity (VA) < 20/80 in the contralateral eye
9. Contraindication to ocular treatment with levofloxacin, tobramycin or dexamethasone
10. Hypersensitivity to the study product or its excipients
11. Participation in other studies in the last month before screening
12. Pregnancy or breastfeeding

1. Afecciones oculares que, en opinión del investigador, pudieran interferir en las evaluaciones de eficacia y/o seguridad (p.ej., herpes ocular, blefaritis, conjuntivitis, uveítis, queratitis, retinopatía diabética, oclusión de la vena retiniana, vasculitis retiniana, proliferación angiomatosa retiniana, síndrome pseudoexfoliativo, síndrome del iris flácido, etc.).
2. Pacientes sometidos a operación de cataratas bilaterales.
3. Pacientes en tratamiento con análogos de la prostaglandina o inyecciones intravítreas de fármacos anti-VEGF (factor de crecimiento endotelial vascular).
4. Enfermedades sistémicas que pudieran interferir en los resultados del estudio (p.ej., artritis reumatoide, síndrome de Sjögren, enfermedad de Behçet, lupus eritematoso sistémico, escleroderma con importante afectación ocular, etc.).
5. Cualquier afección que pudiera interferir en la correcta instilación del colirio.
6. Cirugía ocular en el ojo del estudio (incluida cirugía mediante láser) en los 3 meses anteriores a la selección.
7. Pacientes con visión monocular.
8. Agudeza visual (AV) < 20/80 en el ojo contralateral.
9. Contraindicación al tratamiento ocular con levofloxacino, tobramicina o dexametasona.
10. Hipersensibilidad a los productos o a sus excipientes.
11. Participación en otros estudios en el mes anterior a la selección.
12. Embarazo o lactancia.

E.5 End points

E.5.1

Primary end point(s)

The proportion of patients without signs of anterior chamber inflammation (sum of cells and flare score = 0).

La proporción de pacientes sin signos de inflamación en la cámara anterior del ojo (suma de puntuación de células y flare = 0)

E.5.1.1

Timepoint(s) of evaluation of this end point

After 14 days of treatment.

Tras 14 días de tratamiento.

E.5.2

Secondary end point(s)

Efficacy:
- Incidence of endophthalmitis
- Proportion of patients without signs of anterior ocular chamber inflammation
- Conjunctival hyperemia
- Total Ocular Symptoms Score (TOSS)
- Ocular pain/discomfort
- Use of rescue therapy

Safety and tolerability:
- Intraocular pressure (IOP)
- Visual acuity (ETDRS)
- Adverse events
- Global evaluation
- Burning, stinging, blurred vision

Compliance:
- Assessment of patient diary

Eficacia:
· Incidencia de endoftalmitis
· Proporción de pacientes sin signos de inflamación en la cámara anterior del ojo
· Hiperemia conjuntival
· Puntuación total de síntomas oculares (TOSS, por su sigla en inglés)
· Malestar/dolor ocular
· Uso de la medicación de rescate.
Seguridad:
· Presión intraocular (PIO)
· Agudeza visual
· Acontecimientos adversos
Tolerabilidad:
· Evaluación global
· Quemazón, escozor, visión borrosa
Cumplimiento terapéutico
· Valoración del diario del paciente

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy:
- During treatment
- After 3 and 7 days of treatment
- After 3, 7 and 14 days of treatment
- After 3, 7 and 14 days of treatment
- After 3, 7 and 14 days of treatment
- During treatment

Safety and tolerability:
- After 3, 7 and 14 days of treatment
- After 14 days of treatment
- During treatment
- After 3, 7 and 14 days of treatment
- After 3, 7 and 14 days of treatment

Compliance:
- After 3, 7 and 14 days of treatment

Eficacia:
- Durante el tratamiento
- Después de 3 y 7 días de tratamiento
- Después de 3, 7 y 14 días de tratamiento
- Después de 3, 7 y 14 días de tratamiento
- Después de 3, 7 y 14 días de tratamiento
- Durante el tratamiento

Seguridad y tolerabilidad:
- Después de 3, 7 y 14 días de tratamiento
- Después de 14 días de tratamiento
- Durante el tratamiento
- Después de 3, 7 y 14 días de tratamiento
- Después de 3, 7 y 14 días de tratamiento

Conformidad:
- Después de 3, 7 y 14 días de tratamiento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

enmascarado para el evaluador

blinded-assessor

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

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

Germany

Italy

Russian Federation

Spain

E.8.7

Trial has a data monitoring committee

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

UVUS

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

600

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

700

F.4.2.2

In the whole clinical trial

800

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)

The patients will be managed according to standard routine practice applied by each center.

Los pacientes serán tratados de acuerdo a la práctica clínica habitual aplicada por cada centro.

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

2018-08-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-12-19

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Clinical trials