Clinical Trials Register

Summary
EudraCT Number:	2014-002168-34
Sponsor's Protocol Code Number:	FNB-OK-2013-01
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-09-15
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

Czechia - SUKL

A.2

EudraCT number

2014-002168-34

A.3

Full title of the trial

Study To Determine Efficacy of Aflibercept For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Stanovení účinnosti Afliberceptu v léčbě zmnožení cév uvnitř sítnice způsobeného věkem podmíněnou makulární degenerací

A.3.1

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

Aflibercept Efficacy in Patients Suffering Age-Related Damage of the Yellow Spot of the Light-sensitive Tissue Layer in the Eye

Účinnosti Afliberceptu u pacientů trpících věkem způsobeným poškozením žluté skvrny sítnice oka.

A.4.1

Sponsor's protocol code number

FNB-OK-2013-01

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	Doc. MUDr. Petr Kolář, PhD, Oční klinika FN Brno
B.1.3.4	Country	Czech Republic
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.r.o.
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Doc. MUDr. Petr Kolář, PhD, Oční klinika FN Brno
B.5.2	Functional name of contact point	Petr Kolář
B.5.3	Address:
B.5.3.1	Street Address	Jihlavská 20
B.5.3.2	Town/ city	Brno
B.5.3.3	Post code	62500
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	00420532233263
B.5.5	Fax number	00420532233378
B.5.6	E-mail	pkolar@fnbrno.cz

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
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	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	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

Retinal angiomatous proliferation secondary to wet age related macular degeneration.

Zmnožení cév uvnitř sítnice způsobené „vlhkou“ formou věkem podmíněné makulární degenerace (VPMD).

E.1.1.1

Medical condition in easily understood language

Wet form of age-related damage of the macula with abnormal proliferation of retinal blood vessels (associated with blood leakage as well as epithelial detachments).

Při vlhké formě VPMD se v centrální oblasti sítnice (zvané makula, žlutá skvrna) abnormálně vytvářejí krevní cévy, které jsou slabé a prosakují, což způsobuje jizvení poškozující sítnici.

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	10064930
E.1.2	Term	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	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	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 assess the efficacy of intravitreal aflibercept by assessing the best corrected visual acuity (BCVA) in subjects with retinal angiomatous proliferation (RAP) secondary to wet AMD.

Zhodnotit na základě vyšetření zrakové ostrosti účinnost injekcí Afliberceptu do sklivce u pacientů se zmnožením cév uvnitř sítnice způsobeným „vlhkou“ formou věkem podmíněné makulární degenerace.

E.2.2

Secondary objectives of the trial

To assess other efficacy parameters of intravitreal aflibercept in subjects with retinal angiomatous proliferation (RAP) secondary to wet AMD.

Zhodnotit další parametry účinnosti injekcí Afliberceptu do sklivce u pacientů se zmnožením cév uvnitř sítnice způsobeným „vlhkou“ formou věkem podmíněné makulární degenerace.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Ability to provide written informed consent and comply with study assessments for the full duration of the study.
2) Men and women ≥ 50 years old; women has to be postmenopausal
3) Definite characteristic signs of retinal angiomatous proliferation secondary to wet AMD as determined by clinical signs (retinal oedema, subretinal fluid, sub RPE fluid, retinal or subretinal hemorrhage) and angiography (minimally classic leakage on fluorescein angiography)

E.4

Principal exclusion criteria

A subject who meets any of the following criteria will be excluded from the study.
1) Prior treatment with ranibizumab, bevacizumab, pegaptanib, verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
2) Previous subfoveal focal laser photocoagulation involving the foveal centre in the study eye
3) Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding baseline
4) History of pars plana vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
5) Previous participation in any studies of investigational drugs within 1 month preceding baseline
6) Subjects with scar or fibrosis making up >50% of the total lesion or scar, fibrosis, or atrophy involving the centre of the fovea in the study eye.
7) Subjects with clinical evidence of diabetic macular oedema, diabetic retinopathy or any retinal vascular disease other than AMD in either eye.
8) Subjects with other causes of CNV in the study eye.
9) Subjects with history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
10) Subjects with intraocular pressure >25 mmHg despite treatment with antiglaucoma medication in the study eye.
11) Active intraocular, extraocular and periocular infection in either eye.

E.5 End points

E.5.1

Primary end point(s)

The primary variable is change from baseline in the best corrected visual acuity score (BCVA) on the ETDRS chart at 12 months.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

E.5.2

Secondary end point(s)

Secondary variables are:
1) Proportion of subjects with vision loss of <15 letters in the best corrected visual acuity score (BCVA) on the ETDRS chart at 12 and 24 months compared to baseline
2) Proportion of subjects who gain >15 letters in the best corrected visual acuity score on the ETDRS chart at 6, 12 and 24 months compared to baseline
3) Change from baseline in the best corrected visual acuity score on the ETDRS chart at 6 and 24 months.
4) Proportion of subjects who lose > 15 letters of vision in the best corrected visual acuity score on the ETDRS chart at 6, 12 and 24 months from baseline
5) Change from baseline to 12 and 24 months in CRT as measured by OCT
6) Proportion of subjects who show complete resolution of FA leakage at 12 and 24 months
7) Mean change from baseline in total NEI VFQ-25 score at 12 and 24 months
8) Number of injections during the study period

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months
12 months
24 months

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

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

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.8.2.4

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

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 treatment period for each subject is scheduled to be 24 months.

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)

Expected normal treatment.

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

2014-12-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-11-22

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