Clinical Trials Register

Summary
EudraCT Number:	2015-001368-20
Sponsor's Protocol Code Number:	ECR-AMD-2015-09
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:	2015-12-10
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

2015-001368-20

A.3

Full title of the trial

A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in patients with Polypoidal Choroidal Vasculopathy. (ATLANTIC)

Estudio fase IV, aleatorizado, doble ciego, con control simulado para análisis de la eficacia, seguridad y tolerabilidad de la monoterapia intravítrea de Aflibercept en comparación con Aflibercept y terapia fotodinámica Concomitante en pacientes con Vasculopatía Coroidea Polipoidal. (ATLANTIC)

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

ATLANTIC

A.4.1

Sponsor's protocol code number

ECR-AMD-2015-09

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	AIBILI - Association for Innovation and Biomedical Research on Light and Image
B.1.3.4	Country	Portugal
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer Portugal S.A
B.4.2	Country	Portugal
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CABYC, S.L.
B.5.2	Functional name of contact point	Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	Avenida Somosierra, 12. Portal Izqdo., 2ºG
B.5.3.2	Town/ city	San Sebastián de los Reyes (Madrid)
B.5.3.3	Post code	28703
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34916590433
B.5.5	Fax number	+34916548969
B.5.6	E-mail	jorge.diaz@cabyc.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	Yes
D.2.1.1.1	Trade name	Eylea ® 40mg/mL solution for injection in a vial
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Pharma AG
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.3.4	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.3.9.3	Other descriptive name	AFLIBERCEPT
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	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Fusion protein of portions of human VEGF receptors 1 and 2 extracelular domains fused to the Fc portion of human IgG1, produced in Chinese hámster ovary (CHO) K1 cells by recombinant DNA technology.
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	Visudyne® 15 mg powder for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis European Limited
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.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	verteporfin
D.3.9.1	CAS number	129497-78-5
D.3.9.3	Other descriptive name	VERTEPORFIN
D.3.9.4	EV Substance Code	SUB00044MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	Yes
D.3.11.13.1	Other medicinal product type	Benzoporphyrin derivative monoacids (BPD-MA) consisting of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MD. It is used as a lightactivated medicinal product (photosensitier)

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Polypoidal choroidal vasculopathy (PCV)

Vasculopatía Coroidea Polipoidal (PCV)

E.1.1.1

Medical condition in easily understood language

Age-related macular degeneration(AMD) patients with Polypoidal Choroidal Vasculopathy(VCP)

Pacientes con degeneración macular relacionada con la edad (AMD) con vasculopatía coroidea polipoidal (VCP)

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	18.1
E.1.2	Level	PT
E.1.2	Classification code	10063381
E.1.2	Term	Polypoidal choroidal vasculopathy
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 Aflibercept with and without PDT in AMD
patients diagnosed with PCV, by:
1- Comparing best corrected visual acuity (BCVA) changes at Week 52 in
AMD patients with PCV treated with Aflibercept associated with
verteporfin PDT versus BCVA in AMD patients with PCV treated with
Aflibercept associated with sham PDT.
2- Comparing polyps regression at Week 52 in AMD patients with PCV
treated with Aflibercept associated with verteporfin PDT versus polyps
regression in AMD patients with PCV treated with Aflibercept associated
with sham PDT.
Polyps regression will be defined as a reduction in the total area of
polyps, as assessed by the Central Reading Centre

Para evaluar la eficacia de Aflibercept con y sin PDT en pacientes con AMD diagnosticado con PCV, mediante:
1- Comparación de los cambios en la mejor agudeza visual corregida (BCVA) en la semana 52 en pacientes con AMD con PCV tratados con Aflibercept asociado a PDT con verteporfina versus BCVA en pacientes con AMD y con PCV tratados con aflibercept asociado a PDT simulado.
2- Comparación de la regresión de los pólipos en la semana 52 en pacientes con AMD y con PCV tratados con Aflibercept asociado a PDT con verteporfina versus la regresión de los pólipos en en pacientes con AMD con PCV tratados con Aflibercept asociado a PDT simulado.
La regresión de los pólipos se define como la reducción del área total de los pólipos , tal como se evaluó en el Centro de Lectura de Imágenes.

E.2.2

Secondary objectives of the trial

To evaluate the potential benefit, based on the secondary outcomes, of verteporfin PDT compared to sham PDT in AMD patients diagnosed with PCV treated with Aflibercept under a Treat and Extent treatment regimen.
To evaluate the safety of Aflibercept treatment in patients with PCV.
To characterize morphologically the 2 treatment regimens: Aflibercept T&E associated with verteporfin PDT and Aflibercept T&E associated with sham PDT.

Evaluar el beneficio potencial, basado en los resultados secundarios, de PDT con Verteporfina comparado con PDT simulado en pacientes con AMD diagnosticados con PCV, tratados con Aflibercept bajo un régimen de "Tratar y Extender"
Evaluar la seguridad del tratamiento con Aflibercept en pacientes con PCV.
Caracterizar morfológicamente los dos regímenes de tratamiento: Aflibercept T&E asociado a PDT con Verteporfina y Aflibercept T&E asociado a PDT simulado.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Either gender and Age ? 50.
2.Naïve PCV patients.
3.BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25).
4.Diagnosis of symptomatic macular PCV in the study eye. Subfoveal involvement is required, with intraretinal or subretinal fluid and/or subfoveal PED, demonstrated on SD-OCT. (confirmed by the Central Reading Centre based OCT, CFP, FA and ICGA).
5.Greatest linear dimension of the lesion of ? 5400 µm, assessed by FA/ICGA angiography.
6.Presence of PCV in the study eye assessed by the Central Reading Centre based on ICGA with active polyps with or without abnormal vascular network.
7.Women must be post-menopausal for at least 12 months prior to trial entry, or surgically sterile or in case of child-bearing potential, women must be using highly effective method of birth control (i.e. one that results in a failure rate less than 1% per year when used consistently and correctly, such as, combined hormonal contraception, progestogen-only hormonal contraception, intrauterine devices (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence).
8.Ability to provide written informed consent.
9.Ability to return for all study visits.

1.Cualquier género y Edad ? 50.
2.Pacientes con PCV no tratados anteriormente.
3.BCVA a la entrada del estudio de 25 a 80 letras (Equivalente en la escala Snellen de 20/320 a 20/25).
4.Diagnóstico de PCV macular sintomática en el ojo del estudio. Se precisa afectación subfoveal, con fluido intraretinal o subretinal y/o PED subfoveal, demostrado con SD-OCT. (Confirmado por el Centro de Lectura de Imágenes basado en OCT, CFP, FA e ICGA).
5.Mayor dimensión lineal de la lesión de ? 5400 µm, evaluada por angiografía FA/ICGA.
6.Presencia de PCV en el ojo del estudio evaluado por el Centro de Lectura de Imágenes basado en la ICGA con pólipos activos con o sin red vascular anormal.
7.Las mujeres deben ser post-menopáusicas durante al menos 12 meses antes de la entrada en el ensayo, o esterilizadas quirúrgicamente o en caso de ser fértiles, las mujeres deben utilizar un método anticonceptivo altamente eficaz (i.e., uno cuya tasa de fallo sea menor del 1% al año cuando se utilice sistemática y correctamente, como, contracepción hormonal combinada, contracepción hormonal sólo con progesterona, dispositivos intrauterinos (IUD), dispositivos intrauterinos liberadores de hormonas (IUS), oclusión tubárica bilateral, pareja vasectomizada y abstinencia sexual).
8.Capacidad de proporcionar el consentimiento informado por escrito.
9.Capacidad de volver a todas las visitas del estudio.

E.4

Principal exclusion criteria

1.Active inflammation, infection or periocular infection in the study eye.
2.Uncontrolled intraocular pressure in the study eye.
3.Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
4.Presence of centromacular scarring or atrophy indicating irreversible BCVA loss.
5.Prior treatment of the study eye with anti-VEGF therapy.
6.Systemic use of anti-VEGF products within 3 months prior to the study entry.
7.Previous vitrectomy, aphakia, macular laser treatment, PDT, or intraocular steroids in the study eye.
8.Known serious allergies or history of hypersensitivity to fluorescein, indocyanine, verteporfin or components used of Eyelea® formulation.
9.Subject with a condition (such as advanced, severe or unstable disease or its treatment) or is in a situation which may put him/her at significant risk, which may confound the study results or may interfere significantly with the subject?s participation in the study.
10.History of porphyria and clinically relevant impairment of liver function.

1.Inflamación activa, infección o infección periocular en el ojo del estudio.
2.Presión intraocular no controlada en el ojo del estudio.
3.Afección ocular en el ojo del estudio que puede afectar la visión y confundir los resultados del estudio (P.ej. tracción vitreomacular, membrana epiretinal con impacto en la BCVA, inflamación ocular, enfermedad vascular de la retina como retinopatía diabética o edema macular diabético).
4.Presencia de cicatrices centromaculares o atrofia que indican pérdida irreversible de la BCVA.
5.Tratamiento previo del ojo del estudio con terapia anti-VEGF.
6.Uso sistémico de productos anti-VEGF en los tres meses previos a la entrada en el estudio.
7.Vitrectomía previa, afaquia, tratamiento macular con láser, PDT, o esteroides intraoculares en el ojo del estudio.
8.Alergias graves conocidas o antecedentes de hipersensibilidad a la fluoresceína, indocianina, verteporfina o componentes utilizados en la formulación de Eylea®.
9.Paciente con un proceso (como enfermedad avanzada, grave o inestable o su tratamiento), o en una situación que puede ponerle en un riesgo significativo, que pueda confundir los resultados del estudio o que pueda interferir significativamente con la participación del paciente en el estudio.
10.Antecedentes de porfiria y deterioro clínicamente relevante de la función hepática

E.5 End points

E.5.1

Primary end point(s)

1- Change in BCVA from Baseline to Week 52 (1-year).
2- Polyps regression at Week 52, assessed by ICGA

1- Cambio en la BCVA desde el basal hasta la semana 52 (1 año);
2- Regresión de los pólipos en la semana 52, evaluado mediante ICGA

E.5.1.1

Timepoint(s) of evaluation of this end point

1- Change in BCVA from Baseline to Week 52 (1-year).
2- Polyps regression at Week 52, assessed by ICGA

1- Cambio en BCVA desde el basal hasta la semana 52 (1 año);
2- Regresión de los pólipos en la semana 52, evaluado mediante ICGA

E.5.2

Secondary end point(s)

1-Change in BCVA over time;
2-Change in BCVA at Week 16;
3-BCVA gain ? 5, 10, or 15 Letters at Week 52;
4-BCVA loss ? 5, 10, 15, or 30 Letters at Week 52;
5-BCVA Maintenance at Week 52 (BCVA change from Baseline between - 5 and + 5 Letters, exclusively);
6-Polyps regression at Week 16, assessed by ICGA;
7-Complete polyps regression at Week 52, assessed by ICGA;
8-Complete polyps regression at Week 16, assessed by ICGA;
9-Presence of active polyps at Week 52, assessed by ICGA;
10-Presence of active polyps at Week 16, assessed by ICGA;
11-Presence of leakage based on fluorescein angiography (FA) at Week 52;
12-Change in the Subfield Central Retinal Thickness (CRT) over time (assessed by Optical Coherence Tomography, SD-OCT);
13-Presence of fluid assessed on SD-OCT at Week 52;
14-Total number of treatments with Aflibercept;
15-Total number of treatments with verteporfin PDT;
16-Frequency and severity of ocular and non-ocular adverse events over time.

1.Cambio en BCVA a lo largo del tiempo;
2.Cambio en BCVA en la semana 16;
3.Ganancia de BCVA ? 5, 10, o 15 Letras en la semana 52;
4.Pérdida de BCVA ? 5, 10, 15, o 30 Letras en la semana 52;
5.Mantenimiento de BCVA en la semana 52 (cambio de BCVA desde el basal entre - 5 y + 5 Letras, exclusivamente);
6.Regresión de los pólipos en la semana 16, evaluado mediante ICGA;
7.Regresión completa de los pólipos en la semana 52, evaluado mediante ICGA;
8.Regresión completa de los pólipos en la semana 16, evaluado mediante ICGA;
9.Presencia de pólipos activos en la semana 52, evaluado mediante ICGA;
10.Presencia de pólipos activos en la semana 16, evaluado mediante ICGA;
11.Presencia de ?leakage? basado en la angiografía con fluoresceína (FA) en la semana 52;
12.Cambio en el Espesor del Subcampo Central de la retina (CRT) a lo largo del tiempo (evaluado mediante Tomografía de Coherencia Óptica, SD-OCT);
13.Presencia de fluido evaluado en SD-OCT en la semana 52;
14.Número total de tratamientos con Aflibercept;
15.Número total de tratamientos con PDT con Verteporfina;
16.Frecuencia y gravedad de los acontecimientos adversos oculares y no oculares a lo largo del tiempo.

E.5.2.1

Timepoint(s) of evaluation of this end point

1,2- Change in BCVA at week 16 and over time
3,4- BCVA gain/loss ? 5, 10, or 15 Letters at Week 52
5- BCVA Maintenance at Week 52
6- Polyps regression at Week 16
7,8- Complete polyps regression at Week 16 and Week 52
9,10- Presence of active polyps at Week 16 and Week 52
11- Presence of leakage at Week 52
12- Change in the Subfield Central Retinal Thickness over time
13- Presence of fluid at Week 52
14- Total number of treatments with Aflibercept at Week 52
15- Total number of treatments with verteporfin PDT at Week 52
16- Frequency and severity of ocular and non-ocular adverse events over time.

1,2.Cambio en la BCVA en la semana 16 y a lo largo del tiempo
3,4.Ganancia/pérdida de BCVA ? 5, 10, o 15 letras en la semana 52;
5.Mantenimiento de BCVA en la semana 52
6.Regresión de los pólipos en la semana 16
7,8.Regresión completa de los pólipos en la semana 16 y semana 52
9,10. Presencia de pólipos activos en la semana 16 y semana 52;
11.Presencia de ?leakage? en la semana 52;
12.Cambio en el Espesor del Subcampo Central de la retina (CRT) a lo largo del tiempo
13.Presencia de fluido en la semana 52;
14.Número total de tratamientos con Aflibercept;
15.Número total de tratamientos con PDT con Verteporfina;
16.Frecuencia y gravedad de los efectos adversos oculares y no oculares a lo largo del tiempo.

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

E.8.2.2

Placebo

Yes

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

Última Visita del Último Paciente

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.4.2.2

In the whole clinical trial

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)

Subjects completing the study will be trated at hospital or private clinic according to accepted medical practice.

Los pacientes que completan el estudio se tratarán en el hospital o en la clínica privada de acuerdo a la práctica clínica aceptada.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	EVIRC.net
G.4.3.4	Network Country	Portugal

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-02-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-09-05

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IMP with orphan designation in the indication
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