Clinical Trials Register

Summary
EudraCT Number:	2004-004997-10
Sponsor's Protocol Code Number:	206207-011-00
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-02-06
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

2004-004997-10

A.3

Full title of the trial

`A 3-Year, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial to Assess the Safety and Efficacy of 700 i`g and 350 i`g Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Diabetic Macular Edema`

Studio di 3 anni, di fase tre, multicentrico, cieco, randomizzato, controllo con trattamento simulato per valutare la tollerabilita` e l`efficacia di 700 ?g e 350 ?g di dexametasone da un sistema di rilascio del farmaco inserito nel segmento oculare posteriore? (DEX PS DDS) con applicatore nel trattamento di pazienti con edema maculare diabetico

A.3.1

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

A.4.1

Sponsor's protocol code number

206207-011-00

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00168389

A.5.4

Other Identifiers

Name:

MEAD

Number:

N/A

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	ALLERGAN Limited
B.1.3.4	Country	United Kingdom
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	Allergan
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Allergan - Regulatory Affairs Department
B.5.2	Functional name of contact point	Senior Regulatory Manager
B.5.3	Address:
B.5.3.1	Street Address	1st Floor Marlow International, The Parkway
B.5.3.2	Town/ city	Marlow
B.5.3.3	Post code	SL71YL
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	44-1628-494444
B.5.5	Fax number	441628 494449
B.5.6	E-mail	ml-eu_reg_affairs@allergan.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	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	DS PS DDS
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Ophthalmic insert
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	AGN206207
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350
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.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	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	DS PS DDS
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Ophthalmic insert
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	AGN206207
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	350
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Ophthalmic insert
D.8.4	Route of administration of the placebo	Intraocular use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Ophthalmic insert
D.8.4	Route of administration of the placebo	Intraocular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

diabetic macular edema

edema maculare diabetico

E.1.1.1

Medical condition in easily understood language

to treat damage (swelling) of the retina (the light sentsitive part of the eye) caused by complications of diabete

per il trattamento di danni (gonfiore) della retina (la parte sensibile alla luce degli occhi) causata da complicanze di Diabete

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10025409
E.1.2	Term	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 evaluate the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) and 350 µg DEX PS DDS Applicator System (350 µg dexamethasone) compared with a Sham DEX PS DDS Applicator System (needle-less applicator) in patients with diabetic macular edema.

Valutare la tollerabilita` e l`efficacia del 700 µg DEX PS DDS con applicatore (con 700 µg di dexametasone) e del 350 µg DEX PS DDS con applicatore (con 350 µg di dexametasone) comparati ad un simulatore di DEX PS DDS con applicatore (senz`ago) nel trattamento di pazienti con edema maculare diabetico.

E.2.2

Secondary objectives of the trial

To evaluate the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) compared with the 350 µg DEX PS DDS Applicator System (350 µg dexamethasone) in patients with diabetic macular edema.

Valutare la tollerabilita` e l`efficacia del 700 µg DEX PS DDS con applicatore (con 700 µg di dexametasone) comparato al 350 µg DEX PS DDS con applicatore (con 350 µg di dexametasone) nel trattamento di pazienti con edema maculare diabetico.Valutare la tollerabilita` e l`efficacia del 700 µg DEX PS DDS con applicatore (con 700 µg di dexametasone) comparato al 350 µg DEX PS DDS con applicatore (con 350 µg di dexametasone) nel trattamento di pazienti con edema maculare diabetico

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, at least 18 years of age 2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: - Current regular use of insulin for the treatment of diabetes - Current regular use of oral hypoglycemic agent(s)for the treatment of diabetes - Diabetes as defined by American Diabetes Association (ADA) guidelines: `• Symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) plus plasma glucose concentration at any time of the day regardless of time since last meal ¥ 200 mg/dl (11.1 mmol/l) or `• Eight-hour fasting plasma glucose ¥ 126 mg/dl (7.0 mmol/l) or `• Two-hour postload (75 g) glucose ¥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test 3. Diabetic macular edema in the study eye defined as clinically observable macular edema involving the center of the macula (fovea) associated with diabetic retinopathy, with any of the following characteristics: a) Prior medical therapy for diabetic macular edema b) Prior macular laser(s) for diabetic macular edema with the most recent laser at least 3 months prior to Baseline/ Qualification where, in the opinion of the investigator, the patient will be able to improve 15 or more letters in BCVA from baseline with the resolution of the macular edema despite the presence of macular laser scars c) In the investigator`s opinion the patient would not benefit from macular laser treatment d) The patient refuses laser treatment 4. BCVA score between 34 letters (approximately 20/200 Snellen equivalent) and 68 letters (approximately 20/50 Snellen equivalent) in the study eye measured by the ETDRS method at qualification/baseline 5. Retinal thickness of ¥ 300 µm by OCT in the 1mm central macular subfield of the study eye at qualification/baseline as determined by the investigator 6. Patients who have received intravitreal triamcinolone acetonide must satisfy the following: `• The intended dose for each injection was 4 mg or less `• The most recent dose was at least 6 months prior to qualification/baseline visit `• No treatment-related adverse event was seen that, in the opinion of the investigator, has the potential to worsen or reoccur with study treatment 7. Female patients of childbearing potential must have a negative urine pregnancy test at the randomization (day 0) visit 8. Written informed consent has been obtained 9. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained 10. Written Data Protection Consent (European sites only) has been obtained 11. Written documentation has been obtained, in accordance with state and country privacy requirements, where applicable.

1.Maschi o femmine di almeno 18 anni di eta` 2.Diagnosi di diabete mellito (tipo 1 o tipo 2). Un fattore qualsiasi della lista che segue sara` considerato come sufficiente per dimostrare la presenza di diabete: uso corrente e regolare di insulina per il trattamento del diabete uso corrente e regolare di antidiabetici orali per il trattamento del diabete diabete definito come (secondo le direttive ADA): `•sintomi di diabete (poliuria, polidipsia e inspiegabile perdita di peso) sommati ad una concentrazione plasmatica di glucosio ad un momento qualunque del giorno e senza tenere conto del tempo trascorso dall`ultimo pasto di ¥ 200 mg/dl (11.1 mmol/l) oppure `•concentrazione plasmatica di glucosio dopo 8 ore a digiuno di ¥ 126 mg/dl (7.0 mmol/l) oppure `•concentrazione plasmatica di glucosio a 2 ore dall`assunzione di 75 g di glucosio (nell`ambito di un test di tolleranza al glucosio) di ¥ 200 mg/dl (11.1 mmol/l) 3.Edema maculare diabetico nell`occhio in studio definito come un edema maculare clinicamente osservabile che coinvolge il centro della macula (fovea) ed e` associato ad una retinopatia diabetica e con una delle seguenti caratteristiche: a)pazienti trattati in precedenza con qualsiasi trattamento medico b)pazienti trattati in precedenza con una o piu` sessioni di laser dove il laser piu` recente e` stato effettuato almeno 3 mesi prima della visita basale e dove, nell`opinione dello Sperimentatore, il paziente potra` avere un miglioramento in BCVA in 15 o piu` lettere dalla visita di qualificazione/basale con risoluzione dell`edema maculare nonostante la presenza di cicatrici maculari dovute al laser c)secondo l`opinione dello sperimentatore il soggetto non trarrebbe benefici da un trattamento laser d)il paziente rifiuta il trattamento laser 4. BCVA tra 34 (circa 20/200 equivalenti Snellen) e 68 lettere (circa 20/50 equivalenti Snellen) per l`occhio in studio, misurata con il metodo ETDRS alla visita di qualificazione/basale 5.Spessore retinico > 300 µm misurato con OCT nel raggio di 1mm nel sottocampo centrale maculare dell`occhio in studio alla visita di qualificazione/basale, come determinato dallo sperimentatore 6.Pazienti che hanno ricevuto triamcinolone acetonide intravitreale devono soddisfare i seguenti requisiti: -La dose di ogni iniezione deve essere stata uguale o inferiore a 4 mg -La dose piu` recente e` stata iniettata almeno 6 mesi prima della visita di qualificazione/basale -Non deve essersi verificato alcun evento avverso correlato al farmaco che possa, ad opinione dello Sperimentatore, peggiorare o ripresentarsi con il trattamento in studio 7.Donne fertili devono avere un test di gravidanza negativo nelle urine alla visita di randomizzazione (giorno 0) 8.E` stato ottenuto il consenso informato scritto 9.E` stata ottenuta l`autorizzazione scritta per l`utilizzo e la divulgazione delle informazioni mediche e di ricerca relative allo studio (solo per i centri all`interno degli Stati Uniti) 10.E` stato ottenuto il consenso scritto per la tutela dei dati personali (solo per i centri europei) 11.E` stato ottenuto il consenso scritto per la confidenzialita` secondo i requisiti nazionali e provinciali, dove applicabili.

E.4

Principal exclusion criteria

1. Uncontrolled systemic disease or current immunosuppressive disease (e.g., HIV+, AIDS) 2. Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification/baseline visit 3. Blood HbA1c level greater than 10% at the qualification/baseline visit 4. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification/baseline visit 5. Adjusted glomerular filtration rate (GFR) less than 50 mL/min, based on the Modified Diet in Renal Disease (MDRD) formula adjusted for body surface area, at the qualification/baseline visit 6. Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., severe macular ischemia, extensive macular laser scarring or atrophy) 7. Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid macular edema or any other condition in the study eye which could be contributing to macular edema 8. Presence of an epiretinal membrane or vitreo-retinal interface changes in the study eye which, in the opinion of the investigator, is the primary cause of macular edema, or is severe enough to prevent improvement in visual acuity despite reduction in macular edema 9. History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: 1) a ¥ 10 mm Hg increase in IOP from baseline with an absolute IOP ¥ 25 mm Hg 2) required therapy with 3 or more anti-glaucoma medications 10. History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye. Patients with a history of previous angle-closure or similar conditions that have been successfully treated with either a laser or surgical peripheral iridotomy are allowed as long as the visual fields and optic nerves have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated 11. Ocular hypertension in the study eye at qualification/baseline with any of the following: 1) IOP > 23 mm Hg if taking no anti-glaucoma medications 2) IOP > 21 mm Hg if taking one anti-glaucoma medication 3) use of 2 or more anti-glaucoma medications (combination products should be considered 2 medications) Note: Anti-glaucoma medications or lack thereof must be stable for at least 4 weeks prior to qualification/baseline. 12. Aphakia or presence of anterior chamber intraocular lens in the study eye 13. Active optic disc or retinal neovascularization in the study eye at qualification/baseline 14. Active or history of choroidal neovascularization in the study eye 15. Presence of rubeosis iridis in the study eye at qualification/baseline 16. Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at qualification/baseline 17. History of herpetic infection in the study eye or adnexa 18. Presence of active or inactive toxoplasmosis in either eye at qualification/baseline Due to space resrtiction, only Exclusion Criteria 1-18 are listed.

1.Disturbo sistemico non controllato o malattia immunosoppressiva (per esempio, HIV e/o AIDS) 2.Inizio di terapia medica per il diabete o passaggio da antidiabetici orali alla terapia con insulina nei 4 mesi precedenti la visita di qualificazione/basale 3.Livello di HbA1c (emoglobina glicosilata) nel sangue maggiore del 10% alla visita di qualificazione/basale 4.Insufficienza renale necessitante emodialisi o dialisi peritonea nei 6 mesi precedenti la visita di qualificazione/basale 5.Velocita` di filtrazione glomerulare (GFR) inferiore a 50 ml/minuto, basata su MDRD (Modified Diet in renal Disease) con formula adattata alla superficie corporea, alla visita di qualificazione/basale 6.Qualsiasi disturbo oculare che, secondo lo sperimentatore, impedirebbe un miglioramento di 15 lettere nell`acuita` visiva (per esempio severa ischemia maculare, atrofia o estese cicatrici maculari dovute al trattamento laser) 7. Presenza di un`occlusione venosa di branca retinica, di un`occlusione della vena centrale della retina, di uveite, di edema maculare cistoide pseudofachico o di qualsiasi altro disturbo nell`occhio in studio che potrebbe contribuire all`edema maculare 8.Presenza di membrana epiretinica o di interfaccia vitreo-retinica nell`occhio in studio che, secondo lo sperimentatore, e` la causa primaria dell`edema maculare, o e` sufficientemente seria da rendere impossibili miglioramenti nell`acuita` visiva nonostante riduzione dell`edema maculare 9.Precedente di innalzamento della pressione intraoculare clinicamente significativo a seguito di trattamento con steroidi in un occhio o in entrambi gli occhi che risulta in una delle seguenti condizioni: 1) un innalzamento della pressione intraoculare > 10 mmHg dalla visita di qualificazione basale con un massimo di pressione intraoculare > 25 mmHg 2) richiesta una terapia con 3 o piu` farmaci anti-glaucoma 10.Precedente di glaucoma o alterazione della papilla ottica dovuta a danno glaucomatoso, e/o perdita di campo visivo dovuta al glaucoma nell`occhio in studio. Pazienti con una storia precedente di angolo-chiuso o condizioni simili che sono stati curati con successo con laser o iridotomia periferica sono ammessi se i campi visivi ed i nervi ottici sono stati stabili per piu` 1 anno prima dell`entrata di studio e se possono essere dilatati senza problemi 11.Ipertensione oculare nell`occhio in studio alla visita qualificazione/basale con una delle seguenti condizioni: -pressione intraoculare (IOP) > 23 mmHg se il paziente non assume nessun farmaco anti-glaucoma -pressione intraoculare (IOP) > 21 mmHg se il paziente assume un farmaco anti-glaucoma -uso di 2 o piu` farmaci antiglaucoma (prodotti combinati sono considerati come 2 farmaci) 12.Afachia o presenza di lente intraoculare nella camera anteriore dell`occhio in studio 13.Neovascolarizzazione retinica o del nervo ottico nell`occhio in studio attiva alla visita di qualificazione/basale 14.Precedenti di neovascolarizzazione coroidale o neovascolarizzazione coroidale attiva nell`occhio in studio 15.Presenza di rubeosi dell`iride nell`occhio in studio alla visita di qualificazione/basale 16.Qualsiasi infezione oculare attiva (batterica, virale, parassitica, fungale) in un occhio o in entrambi gli occhi alla visita di qualificazione/basale 17.Precedenti di infezioni erpetiche nell`occhio in studio o negli annessi oculari dello stesso 18.Presenza di toxoplasmosi attiva o inattiva in un occhio o in entrambi gli occhi alla visita di qualificazione/basale. Causa mancanza di spazio, sono stati elencati solo i Criteri di Esc. 1-18

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable for countries/regions other than the United States will be BCVA average change from baseline during the study (AUC approach) using observed data in the study eye. Best Corrected Visual Acuity (BCVA) is the primary efficacy variable and will be measured using the ETDRS method. It will be measured in both eyes (study eye and non-study eye) at the qualification visit and each follow-up visit. BCVA will be performed following manifest refraction, except 1, 7 and 21 days after the study treatment or re-treatment,. At days 1, 7 and 21 after a treatment or re-treatment, visual acuity (VA) evaluations may be performed using refraction obtained at baseline or at the preceding re-treatment visit, respectively. These VA evaluations will be considered as safety measures but not as efficacy measures. All other VA evaluations will be considered as both safety and efficacy measures.

La variabile primaria sull’efficacia per paesi/aree diversi dagli Stati Uniti sara' rappresentata dalla variazione media della BCVA dal momento della visita basale durante lo studio (approccio AUC) utilizzando i dati osservati nell’occhio in studio. BCVA e' la variabile di efficacia primaria e verra' misurata utilizzando il metodo ETDRS. Verra' misurata in entrambi gli occhi (occhio in studio e non) all visita di qualificazione e ad ogni visita di follow up. BCVA verra' calcolata dopo ogni manifestazione refrattaria, tranne nei giorni 1, 7 e 21 dopo il trattamento in studio o ri-trattamento. Nei giorni 1, 7 e 21 dopo un trattamento o ri-trattamento, valutazioni dell`acuita' visiva (VA) potranno essere eseguite usando rifrazione ottenute al basale o alla precedente visita ri-trattamento, rispettivamente. Tali valutazioni VA saranno considerate come misure di sicurezza, ma non come misure di efficacia. Tutte le altre valutazioni VA saranno considerate come misure di sicurezza che di efficacia.

E.5.1.1

Timepoint(s) of evaluation of this end point

36/39 months

36/39 mesi

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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)

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

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

- Stesso farmaco ad altro dosaggio

- same IMP used at different dosage

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

Brazil

Canada

Colombia

India

Korea, Republic of

New Zealand

Philippines

Singapore

South Africa

Taiwan

United States

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

Number of subjects for this age range:

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:

704

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

351

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-02-06.

Yes

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

400

F.4.2.2

In the whole clinical trial

1050

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)

once patients have exited from the study the investigator will be responsible for either continuing their care personally (at the same hospital) or referring them back to their regular ophthalmologist. In either case, patients will be treated according to current best clinical practice with existing treatments.

una volta che i pazienti sono usciti dallo studio lo sperimentatore sara' responsabile sia per continuare la loro cura personalmente (nello stesso ospedale) o di inviarli di nuovo al proprio oculista. In entrambi i casi, i pazienti saranno trattati secondo le attuali migliori prassi clinica con i trattamenti esistenti.

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

2006-02-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-12-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-05-29

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