Clinical Trials Register

Summary
EudraCT Number:	2014-000986-30
Sponsor's Protocol Code Number:	140109
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-05-20
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-000986-30

A.3

Full title of the trial

Intravitreal Aflibercept for Choroidal Neovascularization Secondary to Angioid Streaks (EYLEA-STRIE)

Aflibercept intravitreale per la neovascolarizzazione coroideale secondaria a Strie Angioidi (EYLEA-STRIE)

A.3.1

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

Treatment of a chorioretinal disease characterized by alterations in the elastic lamina of the Bruch's membrane, and which typically manifest themselves as streaks radial departure from the optic nerve

Trattamento di una patologia corioretinica caratterizzata da alterazioni della lamina elastica della membrana di Bruch, e che tipicamente si manifestano come striature radiali a partenza dal nervo ottico

A.3.2

Name or abbreviated title of the trial where available

EYLEA-STRIE

A.4.1

Sponsor's protocol code number

140109

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	IRCCS Ospedale San Raffaele U.O. Oculistica
B.1.3.4	Country	Italy
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 S.p.A.
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	IRCCS Ospedale San Raffaele
B.5.2	Functional name of contact point	U.O. Clinica Oculistica
B.5.3	Address:
B.5.3.1	Street Address	Via Olgettina, 60
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390226432648
B.5.5	Fax number	+390226433643
B.5.6	E-mail	marelli.marta@hsr.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	Yes
D.2.1.1.1	Trade name	Eylea 40 mg/ml solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Pharma AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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 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	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	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

Choroidal neovascularization secondary to angioid streaks .

Neovascolarizzazione coroideale secondaria a Strie Angioidi

E.1.1.1

Medical condition in easily understood language

Proliferation of new blood vessels in the choroid secondary to alterations that occur as streaks starting from the optic nerve

Proliferazione di nuovi vasi sanguigni nella coroide secondaria ad alterazioni che si verificano come striature a partire dal nervo ottico

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10060837
E.1.2	Term	Choroidal neovascularization
E.1.2	System Organ Class	100000004853

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 and safety of intravitreal Aflibercept in patients with choroidal neovascularization in angioid streaks

Valutare l’efficacia e la sicurezza di Aflibercept intravitreale in pazienti affetti da neovasi coroideali in Strie Angioidi

E.2.2

Secondary objectives of the trial

Not Applicable

Non Applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Men and women ≥ 18 years of age
• Presence of CNV associated with angioid streaks, naïve or previously treated with exudative manifestations involving the fovea
• Best-corrected visual acuity (BCVA) between 20/400 and 20/25.
• Signed Informed Consent

• Adulti di ambo i sessi (età uguale o superiore a 18 anni)
• Presenza fluorangiograficamente evidente di CNV, associata a Strie Angioidi, naïve o già trattata, con manifestazioni essudative che coinvolgano la fovea
• Migliore acuità visiva corretta (BCVA) nell’occhio in studio compresa tra 20/400 e 20/25
• Soggetti capaci di comprendere e firmare il Consenso Informato scritto specifico dello studio

E.4

Principal exclusion criteria

• Prior antiangiogenic treatment within 30 days prior the Screening
visit
• Hypersensitivity to the active substance or to any of the excipients
• ocular or periocular infection suspected or in progress
• severe intraocular inflammation in progress
• Inability to document the lesion with retinography, retinal fluorescein angiography (FAG), autofluorescence, optical coherence tomography (OCT) for media opacities, allergy to dyes, lack of venous access.
• Any other medical condition of the eye that can irreversibly affect the visual acuity in the study eye, including amblyopia, ischemic optic neuropathy, clinically significant diabetic macular edema, severe nonproliferative diabetic retinopathy
• Women who are pregnant or breastfeeding. Women of childbearing age will be excluded unless they make use of contraceptive during treatment and for at least 3 months after the last injection of intravitreal Aflibercept

• Pregresso trattamento antiangiogenico nei 30 giorni precedenti alla visita di Screening.
• Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti
• Infezione oculare o perioculare in corso o sospetta
• Infiammazione intraoculare grave in corso
• Impossibilità a documentare la lesione con retinografie, fluorangiografia retinica (FAG), autofluorescenza, tomografia a coerenza ottica (OCT) per opacità dei mezzi diottrici, allergia ai coloranti, mancanza di accesso venoso.
• Ogni altra condizione patologica dell’occhio che possa compromettere in modo irreversibile l’acuità visiva dell’occhio in studio, compresa ambliopia, neuropatia ottica ischemica, edema maculare diabetico clinicamente significativo, retinopatia diabetica non proliferativa di grado severo.
• Donne in gravidanza o allattamento. Le donne in età fertile saranno escluse a meno che non facciano uso di sistemi contraccettivi durante il trattamento e per almeno 3 mesi dopo l’ultima iniezione intravitreale di Aflibercept

E.5 End points

E.5.1

Primary end point(s)

1. Mean average change in BCVA from baseline to month 12
2. Percentage of eyes with stabilization of BCVA within 15 letters at month 12

1. Variazione media della migliore acuità visiva corretta (BCVA) al mese 12 rispetto al basale
2. Percentuale di occhi con stabilizzazione della BCVA entro le 15 lettere al mese 12

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Month 12
2. Month 12

1. 12 mesi
2. 12 mesi

E.5.2

Secondary end point(s)

1. Proportion of eyes gaining at least 15 letters in BCVA from baseline to month 12
2. Changes in central macular thickness as assessed by OCT from baseline to month 12
3. Changes in CNV lesion from baseline to month 12
4. Total number of intravitreal injections performed up to 12 months
5. Frequency and type of Adverse Events ophthalmological and systemic up to 18 months

1. Proporzione di occhi con un miglioramento della BCVA di almeno 15 lettere al mese 12 rispetto al basale
2. Variazioni nello spessore maculare centrale (CMT) all’OCT al mese 12 rispetto al basale
3. Variazioni nelle dimensioni della CNV al mese 12 rispetto al basale
4. Numero totale di iniezioni intravitreali eseguite fino al mese 12
Endpoint di sicurezza:
5. Frequenza e tipo di eventi avversi (oculari e sistemici) fino al mese 18

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Month 12
2. Month 12
3. Month 12
4. Month 12
5. Month 18

1. Mese 12
2. Mese 12
3. Mese 12
4. Mese 12
5. Mese 18

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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

Ultima Visita dell'Ultimo Soggetto

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

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.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

Nessuno

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

2015-03-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-01-15

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

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