Clinical Trials Register

Summary
EudraCT Number:	2014-001639-35
Sponsor's Protocol Code Number:	CRFB002D2404
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-01-21
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-001639-35

A.3

Full title of the trial

A 24-week, randomized, single-masked, multicenter, phase IV study to compare systemic VEGF levels following monthly Intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept until week 24 in patients with visual impairment due to Diabetic Macular Edema (TIDE DME)

Studio di 24 settimane, randomizzato, in singolo cieco, multicentrico di fase IV per confrontare i livelli di VEGF sistemico dopo iniezioni intravitreali mensili di ranibizumab 0,5 mg rispetto ad aflibercept 2 mg a 24 settimane in pazienti con diminuzione visiva causata da edema maculare diabetico (TIDE DME )

A.3.1

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

Comparison of systemic VEGF levels after intravitreal ranibizumab versus
aflibercept injections in patients with diabetic macular edema

Confrontare i livelli di VEGF sistemico dopo iniezioni intravitreali di ranibizumab rispetto ad aflibercept in pazienti con edema maculare diabetico

A.3.2

Name or abbreviated title of the trial where available

TIDE DME

A.4.1

Sponsor's protocol code number

CRFB002D2404

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	NOVARTIS PHARMA SERVICES AG
B.1.3.4	Country	Switzerland
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	Novartis Pharma Services AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	NOVARTIS FARMA S.P.A.
B.5.2	Functional name of contact point	Drug Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni, 1
B.5.3.2	Town/ city	Origgio (VA)
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	0000390296541
B.5.5	Fax number	0039029659066
B.5.6	E-mail	info.studiclinici@novartis.com

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	Lucentis
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	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	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.2	Current sponsor code	RFB002
D.3.9.4	EV Substance Code	SUB22314
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	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
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	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.3.9.2	Current sponsor code	na
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 3
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	Lucentis
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	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	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.2	Current sponsor code	RFB002
D.3.9.4	EV Substance Code	SUB22314
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	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Visual impairment due to diabetic macula edema

diminuzione visiva causata da edema maculare diabetico (TIDE DME )

E.1.1.1

Medical condition in easily understood language

Impaired vision due to an edema in the area of the macula which is caused by an intrinsic substance, so-called vascular endothelial growth factor (VEGF)

L¿Edema maculare diabetico ¿ una condizione progressiva degli occhi, che, se non trattata, pu¿ causare la perdita della visione centrale in uno o entrambi gli occhi perch¿ la macula, che ¿ la parte ce

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10057934
E.1.2	Term	Diabetic macular edema
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 compare systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab (treatment group 1) versus monthly 2mg aflibercept (treatment group 3) as measured by the area under the curve (AUC) from baseline to study week 24

Per confrontare i livelli di VEGF-A sistemico dopo iniezioni intravitreali mensili di ranibizumab 0,5 mg (gruppo di trattamento 1) rispetto ad aflibercept 2 mg mensile (gruppo di trattamento 3) misurati come l'area sotto la curva (AUC) dal basale alla settimana 24.

E.2.2

Secondary objectives of the trial

To compare systemic VEGF-A levels in patients switching from monthly 2
mg aflibercept injections for first three months to monthly 0.5 mg
ranibizumab (treatment group 2) for the next three months compared to
patients treated with monthly 0.5 mg ranibizumab (treatment group 1)
for six months at specific time points from week 12 to week 24.
To compare systemic VEGF-A levels in patients switching from monthly 2
mg aflibercept injections for first three months to monthly 0.5 mg
ranibizumab (treatment group 2) for the next three months compared to
patients treated with monthly 2 mg aflibercept (treatment group 3) for
six months at specific time points from week 12 to week 24.
To evaluate ocular and systemic safety in all the three treatment groups

Confrontare i livelli di VEGF-A sistemico in pazienti che passano da iniezioni mensili di aflibercept 2 mg a ranibizumab 0,5 mg mensile (gruppo di trattamento 2) per i successivi tre mesi, rispetto ai pazienti trattati con ranibizumab 0,5 mg mensile (gruppo di trattamento 1) per sei mesi in momenti specifici dalla settimana 12 alla settimana 24.
Confrontare i livelli di VEGF-A sistemico in pazienti che passano dalle iniezioni mensili di aflibercept 2 mg per i primi tre mesi di tempo a ranibizumab 0,5 mg mensile (gruppo di trattamento 2) per i successivi tre mesi, rispetto ai pazienti trattati con aflibercept 2 mg mensile (gruppo di trattamento 3) per sei mesi in momenti specifici dalla settimana 12 alla settimana 24.
- Valutare la sicurezza oculare e sistemica in tutti e tre i gruppi di trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Male or female patients, = 18 years of age.
•Written informed consent must be obtained before any assessment is
performed.
•Type 1 or Type 2 diabetes mellitus according to ADA (2014) and/or
WHO (2006) classifications (see Appendix 1, Table 13-2) with
glycosylated hemoglobin (HbA1c) = 10% (= 86 mmol/mol) at screening.
Patients should be on dietand/or exercise and/or pharmacological
treatment for diabetes, which must have been stable for at least 3
months.
•Visual impairment due to DME
• Patients with a baseline BCVA of 78 to 24 (20/32–20/320) ETDRS letters

Pazienti di entrambi i sessi di età = 18 anni.
- Consenso informato scritto deve essere ottenuto prima di eseguire qualsiasi valutazione.
- Diabete mellito di tipo 1 o di tipo 2 in base alla classificazione ADA (2014) e/o WHO (2006) con livelli di emoglobina glicosilata (HbA1c) = 10% (= 86 mmol/mol) allo screening. I pazienti devono essere a dieta e/o esercizio e/o trattamento farmacologico per il diabete, che deve essere stabile per almeno 3 mesi.
- Diminuzione visiva causata da DME
- BCVA compresa tra 78 a 24 lettere (20 / 32-20 / 320) (incluse) nell’occhio in studio allo screening e al basale misurate secondo il sistema ETDRS (Early Treatment Diabetic Retinopathy Study)

E.4

Principal exclusion criteria

Systemic medical history and conditions
•Stroke less than 3 months prior to screening.
•Presence of uncontrolled systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening or baseline.
•Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening
Prior or current systemic medication:
•Use of any systemic anti-VEGF drugs (e.g., bevacizumab [Avastin®], ziv-aflibercept [Zaltrap®]) ithin 6 months prior to screening
•Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
•Use of any anti-coagulants agents within 3 months prior to screening
Prior or current ocular treatment or conditions:
For study eye:
•Panretinal laser photocoagulation within 6 months prior to randomization.
•Focal/grid laser photocoagulation within 3 months prior to randomization.
•Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
•Application of intravitreal corticosteroids (incl. corticosteroid releasing
implant, e.g. Ozurdex®) in vitreous within 6 months prior to screening.
Prior application of fluocinolone acetonide releasing implant (Iluvien®)
in vitreous within 36 months prior to screening.
For fellow eye
•Retinal or choroidal neovascularization or macula edema of any cause involving the fovea requiring anti-VEGF treatment at the time of screening or baseline or the anticipation of development of the above mentioned medical conditions requiring anti-VEGF treatment within 6 months past screening or baseline.
•History of treatment with any anti-angiogenic drugs (including any anti-VEGF agents, e.g., bevacizumab [Avastin®]) 6 months prior to screening

Storia medica sistemica e condizioni:
- Ictus nei tre mesi precedenti allo screening.
- Pressione sanguigna non controllata, definita come un valore sistolico = 160 mmHg o diastolico = 100 mmHg al momento dello screening e al basale
- Insufficienza renale che richiede dialisi o trapianto renale o insufficienza renale con livelli di creatinina > 2,0 mg/dl al momento dello screening
Precedenti o attuali trattamenti sistemici:
- uso di qualsiasi farmaco anti-VEGF sistemico (ad esempio, bevacizumab [Avastin], Ziv-aflibercept [Zaltrap®]) nei 6 mesi precedenti lo screening.
- Uso di corticosteroidi sistemici o per via inalatoria per almeno 30 giorni consecutivi, nei 3 mesi precedenti lo screening.
- Uso di farmaci anti-coagulanti nei 3 mesi precedenti lo screening
Precedenti o attuali trattamenti oculari o condizioni:
Per l’occhio in studio:
- Storia di trattamento con eventuali farmaci anti-angiogenici (comprese eventuali farmaci anti-VEGF, ad esempio, il bevacizumab [Avastin]).
- Fotocoagulazione laser panretinica entro 6 mesi prima della randomizzazione.
- Fotocoagulazione laser focale/griglia entro 3 mesi precedenti la randomizzazione.
- Corticosteroidi topici oculari somministrati per almeno 30 giorni consecutivi, entro 3 mesi prima dello screening.
- L'applicazione di corticosteroidi intravitreali (compreso l’impianto di desametasone acetato, per esempio Ozurdex®) nel vitreo entro 6 mesi prima dello screening. Precendenti applicazioni di un impianto di fluocinolone acetonide (Iluvien®) nel vitreo nei 36 mesi precedenti lo screening.
Per l’occhio controlaterale:
- neovascolarizzazione retinica o coroidale o edema maculare di qualsiasi causa che coinvolge la fovea che richiede il trattamento anti-VEGF, al momento dello screening o al basale o l'anticipazione dello sviluppo delle patologie di cui sopra che richiede un trattamento anti-VEGF entro 6 mesi dal momento dello screening o al basale.
- Storia di trattamento con eventuali farmaci anti-angiogenici (compresi eventuali agenti anti-VEGF, ad esempio, il bevacizumab [Avastin]) 6 mesi precedenti lo screening.
Per l'elenco completo dei criteri di esclusione si veda la Sezione 4.2

E.5 End points

E.5.1

Primary end point(s)

The primary variable is the area under the curve (AUC) of VEGF-A levels in plasma following monthly injections of ranibizumab or aflibercept monotherapy measured between baseline and study week 24

La variabile principale è l'area sotto la curva (AUC) dei livelli di VEGF-A nel plasma dopo iniezioni mensili di ranibizumab 0,5 mg o aflibercept 2,0 mg in monoterapia misurati tra il basale e la settimana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 24

E.5.2

Secondary end point(s)

Secondary endpoints are the Comparison of systemic VEGF-A levels in patients switching from monthly 2 mg aflibercept injections to monthly
0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab or aflibercept from baseline. The comparison will be performed at specific time points between week 12 and week 24.

Gli endpoint secondari sono i livelli sistemici VEGF-A in pazienti che passano da iniezioni mensili di aflibercept 2 mg a 0,5 mg mensile ranibizumab rispetto ai pazienti trattati con ranibizumab 0,5 mg o aflibercept mensili rispetto al basale. Il confronto sar¿ effettuato in punti temporali specifici tra la settimana 12 e la settimana 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 12 and week 24

Settimana 12 e settimana 24

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

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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

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

Yes

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

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

Information not present in EudraCT

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

Canada

France

Germany

Italy

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

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

E.8.9.2

In all countries concerned by the trial 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.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)

Lucentis and Eylea are available on the market

Lucentis e Eylea sono in commercio

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

2016-08-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-07-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Clinical trials