Clinical Trials Register

Summary
EudraCT Number:	2017-003899-31
Sponsor's Protocol Code Number:	DBC-AMD-001-D
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-04-09
Trial 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

2017-003899-31

A.3

Full title of the trial

International, multicenter, randomised, blind, sham-controlled, 2x2 cross over phase III clinical trial to assess the efficacy and security of an intravitreal injection of Etamsylate in the improvement of visual acuity of patients with dry age-related macular degeneration.

Ensayo clínico Fase III, internacional, multicéntrico, aleatorizado, enmascarado, controlado con tratamiento fingido, de grupos cruzados (2x2) para evaluar la eficacia y seguridad de la administración intravítrea de Etamsilato en la mejoría de la agudeza visual en pacientes con degeneración macular asociada a la edad seca.

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

JERICHO_D

A.4.1

Sponsor's protocol code number

DBC-AMD-001-D

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	DOBECURE, S.L
B.1.3.4	Country	Spain
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	DR. PEDRO CUEVAS
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Leon Research S.L.
B.5.2	Functional name of contact point	Irene Minguez Ardura
B.5.3	Address:
B.5.3.1	Street Address	Avd. Ordoño II, 37 - 2º Dcha.
B.5.3.2	Town/ city	Leon
B.5.3.3	Post code	24001
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034987261 064
B.5.5	Fax number	0034987216 243
B.5.6	E-mail	iminguez@leonresearch.es

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	DICYNONE 250mg/2ml, solution injectable
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI AVENTIS FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
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	DICYNONE
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	Etamsylate
D.3.9.1	CAS number	2624-44-4
D.3.9.3	Other descriptive name	ETAMSYLATE
D.3.9.4	EV Substance Code	SUB11943MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µl microlitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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

Aged related macula degeneration (AMD)

Degeneración macular asociada a la edad (DMAE)

E.1.1.1

Medical condition in easily understood language

Aged related macula degeneration (AMD)

Degeneración macular asociada a la edad (DMAE)

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	10025409
E.1.2	Term	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 assess the efficacy after 90 days of a single intravitreal injection of Etamsylate in the improvement of visual acuity in patients diagnosed with dry AMD.

Establecer la eficacia a los 90 días de una inyección única intravítrea de etamsilato en la mejora de la agudeza visual en pacientes diagnosticados de DMAE seca.

E.2.2

Secondary objectives of the trial

To assess the efficacy after 90 and 180 days of a single intravitreal injection of Etamsylate in the reversion of structural retinae changes secondary to AMD.
To assess the efficacy after 90 and 180 days of a single intravitreal injection of Etamsylate in patient’s quality of life.

Evaluar la eficacia después de 90 y 180 días de una única inyección intravítrea de Etamsylate en la reversión de los cambios estructurales de retina secundarios a la DMAE.
Evaluar la eficacia después de 90 y 180 días de una única inyección intravítrea de Etamsylate en la calidad de vida del paciente.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adult patients, aged ≥18 years, males or females.
Diagnosis of dry AMD
Patients with best corrected visual acuity (BCVA) between 20/25 and 20/320, measured by ETDRS optotype (Early Treatment Diabetic Retinopathy Study)
Patients with the capacity and disposition to follow the study protocol and procedures and that grant their informed consent in writing (signed and dated), accepting voluntarily to participate in the trial

Pacientes adultos (18 años o más) de ambos sexos.
Pacientes con DMAE seca (véanse las definiciones de DMAE seca en el texto del protocolo establecidas para el presente ensayo clínico).
Pacientes que presenten una mejor agudeza visual corregida entre 20/25 y 20/320, evaluada mediante el optotipo ETDRS (Early Treatment Diabetic Retinopathy Study).
Pacientes con capacidad y voluntad para seguir el protocolo del estudio y que otorguen su consentimiento informado (fechado y firmado), aceptando participar voluntariamente en el estudio

E.4

Principal exclusion criteria

Patients with grade 5 AMD in one or both eyes.
Patients with any concomitant ocular disease that, under investigator’s judgement, could influence the development, evaluation or assessment of the AMD, such as glaucoma, permanent structural damage in the centre of the fovea, Geographic parafoveolar atrophy, Polypoid choroidal vasculopathy etc.
Patients with any concomitant disease that, under investigator’s judgement, could influence (the disease itself or its treatment) the development, evaluation or assessment of the AMD, such as diabetes mellitus with ocular affectation, current or active systemic infection, any ocular infection, psychiatric diseases, social situation that may affect study protocol compliance etc.
• Patients treated with any intravitreal anti-VEGF agent within the last month prior to study randomisation entry
• Pregnant or breastfeeding women (urine pregnancy test to be performed for those patients of childbearing potential patients)

Pacientes con DMAE de 5º grado en uno de los dos ojos.
Pacientes que presenten alguna patología ocular que, a juicio del investigador pueda influir en el desarrollo, evolución o valoración de la DMAE, como glaucoma, daños estructurales permanentes en el centro de la fóvea, atrofia geográfica parafoveolar, vasculopatía coroidea polipoidal, etc.
Pacientes con enfermedades concomitantes que, a juicio del investigador puedan influir (por la enfermedad en sí y/o sus tratamientos) en el desarrollo, evolución o valoración de la DMAE, como diabetes mellitus con afectación ocular, infección sistémica en curso o activa, cualquier infección ocular, trastornos psiquiátricos, situaciones sociales que puedan afectar al cumplimiento con los requisitos del estudio, etc.
Pacientes que hayan recibido tratamiento con algún fármaco anti-VEGF intravítreo en el último mes.
Mujeres embarazadas o en periodo de lactancia.

E.5 End points

E.5.1

Primary end point(s)

The trial’s primary endpoint is, for each subject, the difference in number of letters read in the ETDRS optotype between the baseline values and after 90 and 180 days of a single intravitreal injection of Etamsylate expressed in in negative decimal logarithmic units of the Minimum Angle Resolution (logMAR).

El criterio principal de eficacia, para cada sujeto, es la diferencia en el número de letras leídas en el optotipo ETRS entre la visita basal y tras 90 y 180 días de una inyección de etamsilato intravítrea única, expresado en unidades decimales logarítmicas del ángulo de resolución mínimo (logMAR).

E.5.1.1

Timepoint(s) of evaluation of this end point

After 90 and 180 days from the baseline

Después de 90 y 180 días desde la línea de base

E.5.2

Secondary end point(s)

Evolution from baseline at 90 and 180 days after etamsylate intravitreal injection of corrected visual acuity assessed by ETDRS optotype and expressed in in negative decimal logarithmic units of the Minimum Angle Resolution (logMAR) equivalent to the number of letters accurately read.
Evolution from the baseline at 90 and 180 days after Etamsylate intravitreal injection of the number of letters read correctly (counted from the upper left corner) in the ETDRS optotype.
Percentage of patients showing an improvement of the best-corrected visual acuity assessed with ETDRS.
Evolution of the thickness of the central part of the macula measured by OCT.
Evolution of the number of targeted areas of retinal pigment epithelium disappearance measured by OCT.
Evolution of the number, location, area and volume of drusen measured by OCT and colour retinography.
In those patients with the most advanced form of AMD (presence of geographical atrophy), the percentage of increase or decrease of the geographical atrophy area.
Evolution of patient’s quality of life measured by Visual Function Questionnaire of National Eye Institute (VFQ-25) and EuroQol five dimensions-five levels questionnaire (EQ-5D-5L).
Evolution compared with non-concurrent control group of corrected visual acuity assessed by ETDRS optotype. This group will include patients treated with any treatment alternatives, standard of care and observation.

Evolución desde la visita basal a los 90 y 180 días de la mejor agudeza visual corregida determinada mediante el optotipo ETDRS y expresada en unidades logMAR equivalentes al número de letras leídas correctamente.
Evolución desde la visita basal a los 90 y 180 días del número de letras leídas correctamente (contadas desde la esquina superior izquierda) en el optotipo ETDRS.
Proporción de pacientes que presentan una mejoría de la mejor agudeza visual corregida en el optotipo ETDRS.
Evolución del grosor de la parte central de la mácula medido mediante tomografía de coherencia óptica (OCT).
Evolución del número de áreas focalizadas de desaparición del epitelio pigmentario de la retina medidas mediante OCT.
Evolución del número, localización, área y volumen de las drusas medido mediante OCT y retinografía en color.
En los pacientes que presenten la forma más avanzada (presencia de atrofia geográfica) se evaluará el incremento o la disminución porcentual del área de la atrofia geográfica
Evolución de la calidad de vida de los pacientes medida mediante el Cuestionario de la Función Visual-25 del National Eye Institute (VFQ-25) y el EuroQoL 5-Dimensiones 5-niveles (EQ-5D-5L).
Evolución de la agudeza visual corregida evaluada con optotipo ETDRS comparada con un grupo de control no concurrente. Este grupo incluirá pacientes tratados con esta u otra alternativa de tratamiento, tratamiento habitual y simple observación.

E.5.2.1

Timepoint(s) of evaluation of this end point

After 90 and 180 days from the baseline

Después de 90 y 180 días desde la línea de base

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

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Tratamiento fingido

Fingered Treatment

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

E.8.9.2

In all countries concerned by the trial months

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

None

Ninguno

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

2018-05-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-25

P. End of Trial
P.	End of Trial Status	Ongoing

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