Clinical Trials Register

Summary
EudraCT Number:	2014-002384-15
Sponsor's Protocol Code Number:	3.0
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-09-19
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

Austria - BASG

A.2

EudraCT number

2014-002384-15

A.3

Full title of the trial

Intravitreal Aflibercept treatment in RAP-Lesions, PED, hemorrhagic CNV and PCV

Untersuchung der Wirksamkeit von Aflibercept bei Sonderformen der neovaskulären altersbedingten Makuladegeneration

A.3.1

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

Investigation of effectiveness of intravitreal aflibercept treatment in special forms of exsudative maculopathies

Untersuchung der Wirksamkeit von Aflibercept bei Sonderformen der neovaskulären altersbedingten Makuladegeneration

A.3.2

Name or abbreviated title of the trial where available

Aflibercept treatment for RAP, PED, hemorrhagic CNV and PCV

A.4.1

Sponsor's protocol code number

3.0

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	Universitätsklinik für Augenheilkunde und Optometrie
B.1.3.4	Country	Austria
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	Universitätsklinik für Augenheilkunde und Optometrie
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien
B.5.2	Functional name of contact point	MUW
B.5.3	Address:
B.5.3.1	Street Address	Waehringer Guertel 18-20
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+4314040079310
B.5.5	Fax number	+4314040079320
B.5.6	E-mail	stefan.sacu@meduniwien.ac.at

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 intravitreal 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	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 injection 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.3.9.2	Current sponsor code	AVE0005
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	25
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

Exsudative Maculopathies

E.1.1.1

Medical condition in easily understood language

Exsudative Maculopathies

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	17.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10052501
E.1.2	Term	Detachment of retinal pigment epithelium
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10069125
E.1.2	Term	Retinal angiomatous proliferation
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10060823
E.1.2	Term	Choroidal neovascularisation
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 investigate the effect of intravitreal Aflibercept treatment on the visual outcome in patient with exsudative maculopathies such as Rap-lesions, PED, hemorrhagic CNV and PCV.

E.2.2

Secondary objectives of the trial

Retinal vessel diameters, retrobulbar flow velocities, anatomic changes in the macula region as assessed with a Spectralis-OCT, angiographic outcomes, macular pigment density

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Treatment naïve eyes with following subtypes of exsudative maculopathies will be included:
• Retinal angiomatous proliferation lesions (RAP)
• Pigment epithelium detachment (PED)
• Hemorrhagic CNV (if the size of hemorrhage is either >50% of the lesion area or >1 disk area in size) )
• Polypoidal choroidal vasculopathy (PCV)
Patients who have a BCVA score better than 20/400 in the study eye using ETDRS
Willingness and able to comply with clinic visits and study-related procedures
Proved a signed informed consent form

E.4

Principal exclusion criteria

Any prior treatment for exsudative maculopathy including photodynamic therapy and intravitreal anti-VEGF application in the study eye
Any surgical treatment of the eye within 3 months prior to baseline in the study eye
History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.)
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
Aphakia or absence of the posterior capsule in the study eye
Presence of a retinal pigment epithelial tear involving the macula in the study eye.
Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the twelve-month study period to prevent or treat visual loss that might result from that condition
Active intraocular inflammation (grade trace or above) in the study eye.
Active or suspected ocular or periocular infection in the study eye.
Any active infection involving eyeball adnexa
Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
in the study eye
Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
Other ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study.
Pregnant or breast-feeding women.
Women of childbearing potential with either a positive pregnancy test result or no
pregnancy test at baseline are excluded. Postmenopausal women must be amenorrheic
for at least 12 months in order not to be considered of child bearing potential.
Sexually active men or women of childbearing potential who are unwilling to practice
adequate contraception during the study are excluded. (adequate contraceptive
measures include stable use of oral contraceptives or other prescription
pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening;
intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus
contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or
jelly)
Allergy to fluorescein
Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)

E.5 End points

E.5.1

Primary end point(s)

Visual acuity

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year

E.5.2

Secondary end point(s)

Retinal vessel diameters
retrobulbar flow velocities
anatomic changes in the macula region as assessed with a Spectralis-OCT
angiographic outcomes
macular pigment density

E.5.2.1

Timepoint(s) of evaluation of this end point

one year

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

E.8.1.1

Randomised

E.8.1.2

Open

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.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

The trial ends one year after the initial treatment for the last enrolled patient.

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

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.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 treated at the Department of Ophthalmology at the Medical University of Vienna.

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

2014-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-04-30

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