Clinical Trials Register

Summary
EudraCT Number:	2012-001910-40
Sponsor's Protocol Code Number:	OPHT-120312
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:	2012-04-30
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

2012-001910-40

A.3

Full title of the trial

The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy

Die Wirkung von intravenösen Glukokortikoiden auf den Tränenfilm bei endokriner Orbitopathie

A.3.1

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

The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy

Die Wirkung von intravenösen Glukokortikoiden auf den Tränenfilm bei endokriner Orbitopathie

A.3.2

Name or abbreviated title of the trial where available

Tearfilm in eyes with TAO

A.4.1

Sponsor's protocol code number

OPHT-120312

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	Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
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	Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
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	Medizinische Universität Wien
B.5.2	Functional name of contact point	Univ. Klinik f. Klin. Pharmakologie
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431404002981
B.5.5	Fax number	+431404002998
B.5.6	E-mail	klin-pharmakologie@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	Urbason solubile 250 mg-Trockenampullen mit Lösungsmittel
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis GmbH, 1220 Vienna
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Urbason solubile 250 mg
D.3.2	Product code	0147507
D.3.4	Pharmaceutical form	Powder and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METHYLPREDNISOLONE HYDROGEN SUCCINATE
D.3.9.1	CAS number	2921-57-5
D.3.9.4	EV Substance Code	SUB12159MIG
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	250
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

Thyroid-associated ophthalmopathy (TAO)

endokrine Orbitopathie

E.1.1.1

Medical condition in easily understood language

Graves-Basedow disease

Morbus Basedow

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	LLT
E.1.2	Classification code	10065624
E.1.2	Term	Graves-Basedow disease
E.1.2	System Organ Class	10014698 - Endocrine 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 change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids

Einfluss der Glukokortikoidtherapie auf die Tränenfilmdicke bei Patienten mit endokriner Orbitopathie

E.2.2

Secondary objectives of the trial

Break up time (BUT)
Visual Acuity
Tear film osmolarity
Degree of exophthalmia
Palpebral fissure width
OSI (Objective Scattering Index)
Impression cytology
Tear cytokines/chemokines
Staining of the cornea with fluorescein
Schirmer I test
Subjective symptoms of dry eye syndrome

Tränenfilmaufreißzeit
Tränenfilmosmolarität
OSI Index
Anfärbung der Hornhaut mit Fluorescein Streifen
Impressionszytologie
Zytokin- und Chemokinbestimmung in der Tränenflüssigkeit
Schirmer I Test
Grad des Exophthalmus
Subjektive Symptome

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Men and women aged over 18 years
- Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance.
- Normal ophthalmic findings except symptoms associated with TAO
- Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme

- Männer und Frauen über 18 Jahre
- Vorliegen einer endokrinen Orbitopathie mit entzündlicher Aktivität, sonst blande Ergebnisse bei der Augenuntersuchung
- Aktive endokrine Orbitopathie aufgrund Morbus Basedow mit einem Clinical Activity Score (CAS) > 3 oder kürzliche Verschlechterung einer bestehenden Proptose, Lidretraktion oder Augenmotilitätsstörungen
- Geplante Therapie mit systemischen Glukokortikoiden nach dem Kahaly Schema

E.4

Principal exclusion criteria

- Chronic inactive TAO
- Previous treatment with oral or intravenous glucocorticoids 3 months preceeding the study
- Participation in a clinical trial in the 3 weeks before the screening visit
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- Wearing of contact lenses
- Intake of dietary supplements in the 3 months preceding the study
- Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
- Ocular infection
- Ocular surgery in the 3 months preceding the study
- Sjögren’s syndrome
- Stevens-Johnson syndrome
- Pregnancy, planned pregnancy or lactating

- Chronisch inaktive endokrine Orbitopathie
- Behandlung mit Corticosteroiden 3 Monate vor Beginn dieser Studie
- Teilnahme an einer klinischen Studie in den 3 Wochen vor der Voruntersuchung
- Symptome einer klinisch relevanten Erkrankung in den 3 Wochen vor Beginn dieser Studie
- Vorliegen oder Vorgeschichte einer schwerwiegenden Erkrankung, die sich nicht mit dem Ziel dieser Studie vereinbaren lässt, nach Einschätzung des Studienarztes
- Tragen von Kontaktlinsen
- Einnahme von Nahrungsergänzungsmitteln in den letzten 3 Monaten
- Lokale Behandlung mit einer ophthalmologischen Medikation in den 4 Wochen vor Beginn der Studie mit Ausnahme von topischen Lubrikantien
- Vorliegen einer okulären Infektion oder klinisch signifikanten Entzündung
- Augenoperation in den 3 Monaten vor Beginn der Studie
- Sjögren's Syndrom
- Stevens-Johnson Syndrom
- Vorliegen einer Schwangerschaft, geplante Schwangerschaft, oder stillende Frauen

E.5 End points

E.5.1

Primary end point(s)

Efficacy

Wirksamkeit

E.5.1.1

Timepoint(s) of evaluation of this end point

after 6- and 12-weeks-treatment

nach 6 und 12 Wochen Behandlungsdauer

E.5.2

Secondary end point(s)

Tolerability

Tolerabilität

E.5.2.1

Timepoint(s) of evaluation of this end point

after 6- and 12-weeks-treatment

nach 6 und 12 Wochen Behandlungsdauer

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

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

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.8.3

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.8.4.1

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

Yes

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 study may be prematurely terminated if SAEs or other significant side effects related to the medical product occurs.

Beim Auftreten von SAEs oder signifikanten Nebenwirkungen im Zusammenhang mit der Studienmedikation wird die Studie vorzeitig beendet.

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)

Medical follow-up by the department of ophthalmology of the medical university of vienna

Weiterbetreuung durch die Universitätsklinik für Augenheilkunde und Optometrie der Medizinischen Universität Wien

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

2012-06-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-07-17

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