Clinical Trials Register

Summary
EudraCT Number:	2020-004694-46
Sponsor's Protocol Code Number:	OPT-302-1005
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:	2021-07-15
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

2020-004694-46

A.3

Full title of the trial

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)

Estudio en fase III, multicéntrico, doble ciego y aleatorizado para evaluar la eficacia y seguridad de OPT-302 intravítreo en combinación con aflibercept, en comparación con aflibercept en monoterapia, en participantes con degeneración macular asociada a la edad (DMAE)

A.3.1

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

A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneration

Estudio de OPT-302 en combinación con aflibercept, en comparación con aflibercept solo, en participantes con degeneración macular asociada a la edad.

A.3.2

Name or abbreviated title of the trial where available

COAST

A.4.1

Sponsor's protocol code number

OPT-302-1005

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	Opthea
B.1.3.4	Country	Australia
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	Opthea Limited
B.4.2	Country	Australia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FISABIO
B.5.2	Functional name of contact point	Maria Carmen Desco Esteban
B.5.3	Address:
B.5.3.1	Street Address	Avenida Pío Baroja, 12
B.5.3.2	Town/ city	Valencia
B.5.3.3	Post code	46015
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34962 78 76 20
B.5.6	E-mail	carmen.desco@uv.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	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	OPT-302
D.3.2	Product code	OPT-302
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	Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed INN at this stage)
D.3.9.2	Current sponsor code	OPT-302
D.3.9.3	Other descriptive name	OPT-302
D.3.9.4	EV Substance Code	SUB191360
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	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 40mg/ml solution for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer AG, Germany
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.3.4	Pharmaceutical form	Solution for infusion in pre-filled syringe
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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Injection
D.8.4	Route of administration of the placebo	Intravitreal use

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 (wet AMD)

Degeneración macular asociada a la edad (DMAE) exudativa.

E.1.1.1

Medical condition in easily understood language

Chronic eye disease that causes blurred vision or a blind spot in one´s visual field caused by abnormal blood vessels leaking fluid or blood into the part of the retina responsible for central vision

Enfermedad ocular crónica que causa visión borrosa o un punto ciego en el campo visual causado por vasos sanguíneos anormales que filtran líquido/sangre en la parte de la retina.

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	SOC
E.1.2	Classification code	10015919
E.1.2	Term	Eye disorders
E.1.2	System Organ Class	10015919 - Eye disorders

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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10067791
E.1.2	Term	Wet 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 determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD.

Determinar la eficacia de 2,0 mg de OPT-302 intravítreo cuando se administra en combinación con 2,0 mg de aflibercept intravítreo en participantes con DMAE exudativa

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept from Baseline to (and at) Week 52 as determined by:
Efficacy:
• Changes in ETDRS BCVA letter score
• Changes in anatomical parameters (CNV area, CST, SRF and IR cysts)
• Changes in National Eye Institute 25-item Vision Function Questionnaire (NEI-VFQ-25).
Participant Reported Outcomes (PROs).
Safety:
• Incidence of adverse events (AEs)
• Deterioration in ETDRS BCVA letter score
• Incidence of ADA formation.
Pharmacokinetic:
• Pharmacokinetic parameters of OPT-302.

Determinar los efectos de la adición de 2,0 mg de OPT-302 intravítreo a 2,0 mg de aflibercept intravítreo desde el inicio hasta (y en) la semana 52 en cuanto a:
Eficacia:
• Cambios en la puntuación de agudeza visual con la mejor corrección (AVMC) de la prueba del estudio de tratamiento precoz de la retinopatía diabética (ETDRS)
• Cambios en los parámetros anatómicos (área de neovascularización coroidea [NVC], grosor del subcampo macular central [GSMC], líquido subretiniano [LSR] y quistes intrarretinianos [IR])
• Cambios en los resultados comunicados por los participantes (RCP) mediante el cuestionario de 25 elementos sobre función visual del National Eye Institute (NEIVFQ-25)
Seguridad:
• Incidencia de los acontecimientos adversos (AA)
• Disminución de la puntuación de AVMC evaluada con la prueba ETDRS
• Incidencia de la formación de anticuerpos (AAF) contra OPT-302
Farmacocinética:
• Farmacocinética del OPT-302.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female participants at least 50 years of age.
• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

• Participantes varones o mujeres de al menos 50 años de edad.
• Lesión activa por NVC subfoveal o lesión por NVC yuxtafoveal (entre 1-199 μm de la fóvea) con afectación de la fóvea (confirmada con un derrame medido por angiografía fluoresceínica [AF] o líquido intrarretiniano o líquido subretiniano mediante TCO-DE) secundaria a la DMAE en el ojo evaluado
• Una puntuación de AVMC evaluada con la prueba ETDRS de entre 60 y 25 letras (ambas inclusive) en el ojo evaluado.

E.4

Principal exclusion criteria

Study Eye
• Any previous treatment for neovascular AMD.
• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

Note: other protocol exclusion criteria may also apply.

Ojo evaluado:
• Cualquier tratamiento previo para la DMAE exudativa.
• Trastornos oculares de importancia clínica (distintos de la DMAE exudativa), que puedan, a criterio del investigador, interferir con la evaluación de la AVMC, la evaluación de la seguridad o la obtención de imágenes del fondo de ojo.
• Cualquier condición médica, psicológica o social actual (o antecedentes de una) que impida la inscripción en el estudio.

Nota: aplican otros criterios de exclusión según protocolo.

E.5 End points

E.5.1

Primary end point(s)

Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]

Cambio medio desde el inicio hasta la semana 52 en la puntuación de AVMC evaluada con la prueba ETDRS.

E.5.1.1

Timepoint(s) of evaluation of this end point

52 Weeks

52 semanas

E.5.2

Secondary end point(s)

Efficacy
• Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
• Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
• Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: at Week 52 ]
• Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) [ Time Frame: Baseline to Week 52 ]
• Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 52 ]
• Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score [ Time Frame: Baseline to Week 52 ]
• Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.

Eficacia
• Proporción de participantes que alcanzan una puntuación de AVMC de 10 o más letras, evaluada con la prueba ETDRS, desde el inicio hasta la semana 52
• Proporción de participantes que alcanzan una puntuación de AVMC de 15 o más letras, evaluada con la prueba ETDRS, desde el inicio hasta la semana 52
• Proporción de participantes con ausencia de líquido subretiniano y quistes intrarretinianos mediante tomografía de coherencia óptica de dominio espectral (TCO-DE) en la semana 52
• Cambio en el área de neovascularización coroidea por angiografía fluoresceínica (AF) desde el inicio hasta la semana 52
• Cambio en el grosor del subcampo macular central medido por TCO-DE desde el inicio hasta la semana 52
• Cambio en la puntuación compuesta de NEI VFQ-25 desde el inicio hasta la semana 52
• Cambio en la puntuación compuesta media de 25 preguntas. Un cambio medio más alto significa una mejora general en la función visual.

E.5.2.1

Timepoint(s) of evaluation of this end point

52 Weeks

52 semanas

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

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Inyección simulada

Sham Injection

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

Australia

Brazil

Canada

Colombia

India

Israel

Korea, Republic of

Malaysia

Philippines

Puerto Rico

Russian Federation

Taiwan

Ukraine

United States

Austria

Bulgaria

Croatia

Denmark

Estonia

France

Germany

Greece

Hungary

Italy

Latvia

Lithuania

Netherlands

Poland

Slovakia

Spain

United Kingdom

Czechia

Argentina

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

Última visita 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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

890

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

Yes

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

319

F.4.2.2

In the whole clinical trial

990

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)

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

2021-07-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-09

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

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