Clinical Trials Register

Summary
EudraCT Number:	2011-001078-25
Sponsor's Protocol Code Number:	H.34.04.04.07.B1
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-21
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

UK - MHRA

A.2

EudraCT number

2011-001078-25

A.3

Full title of the trial

Long-term Follow-up of Patients Who Participated in the Multicenter Uveitis Steroid Treatment Trial (MUST Trial Follow-up Study).

A.3.1

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

Long term follow-up clinical trial to the MUST trial which investigates which treatment of systemic steroid treatment and a steroid implant which is inserted into the eye gives the best visual outcome for patients with chronic eye inflammation.

A.3.2

Name or abbreviated title of the trial where available

MUST FS

A.4.1

Sponsor's protocol code number

H.34.04.04.07.B1

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	National Institute of Health, National Eye Institute
B.1.3.4	Country	United States
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	National Institute of Health, National Eye Institute
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	National Institute of Health, National Eye Institute
B.5.2	Functional name of contact point	Sue Lightman
B.5.3	Address:
B.5.3.1	Street Address	Egerton Road
B.5.3.2	Town/ city	Guilford
B.5.3.3	Post code	GU2 7XX
B.5.3.4	Country	United States
B.5.4	Telephone number	02075662266
B.5.5	Fax number	02072519350
B.5.6	E-mail	s.lightman@ucl.ac.uk

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	Retisert
D.2.1.1.2	Name of the Marketing Authorisation holder	Bausch & Lomb
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/05/261
D.3 Description of the IMP
D.3.1	Product name	Retisert
D.3.2	Product code	C05AA10
D.3.4	Pharmaceutical form	Implant
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	FLUOCINOLONE ACETONIDE
D.3.9.1	CAS number	67-73-2
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	590
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

Non-infectious pan, intermediate and posterior uveitis (inflammatory eye disease)

E.1.1.1

Medical condition in easily understood language

Non-infectious uveitis (inflammatory eye disease)

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	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10033687
E.1.2	Term	Panuveitis
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10046851
E.1.2	Term	Uveitis
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10036370
E.1.2	Term	Posterior uveitis
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10022557
E.1.2	Term	Intermediate uveitis
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

The main purpose of this trial is to compare how two different uveitis treatments control uveitis over a longer period of time. The two treatments are:

A) a local ocular treatment with an implant filled with a corticosteroid medicine called fluocinolone acetonide and
B) systemic treatment with corticosteroid and if needed other immunosuppressive medicines taken by mouth.

E.2.2

Secondary objectives of the trial

This trial is also being conducted to get information about what happens to patients with different types of uveitis (inflammation of the eye) over time. This information may help researchers understand uveitis better and may suggest ways of improving treatment. These include looking at side-effects of treatments such as cataracts and glaucoma.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Only patients that are currently enrolled in the Multicentre Uveitis Steroid Treatment (MUST) Trial (EudraCT number: 2007-003612-53, REC reference: 07/H0311/200) will be invited to participate in this trial. Therefore the inclusion criteria have not been stipulated for the this trial i.e. no naive patients will be enrolled. All the participants in the MUST trial are at least 18 years old.

The main inclusion criteria for the MUST trial are as follows:
1) Age 13 years or older ( we did not recruit patients less than 18 years old)
2) Diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis by a MUST-certified ophthalmologist
3) Active uveitis of a degree for which systemic corticosteroid therapy is indicated in the judgment of a MUST-certified ophthalmologist or such uveitis active within the last 60 days as determined either by examination by a MUST-certified ophthalmologist or by review of ophthalmic medical records by a MUST-certified ophthalmologist
4)Uveitis with or without an associated systemic disease is acceptable; however, the
systemic disease must not be sufficiently active that it dictates therapy with oral
corticosteroids or immunosuppressive agents at the time of study entry;
5) Best-corrected visual acuity (BCVA) of hand motions or better in at least one eye with uveitis
6) Baseline intraocular pressure 24 mm Hg or less in all eyes with uveitis
7) Collection of required baseline data within 10 days prior to randomization
8) Signed informed consent

E.4

Principal exclusion criteria

Only patients that are currently enrolled in the Multicentre Uveitis Steroid Treatment (MUST) Trial (EudraCT number: 2007-003612-53, REC reference: 07/H0311/200) will be invited to participate in this trial. Therefore the exlusion criteria have not been stipulated for the this trial.

The main exclusion criteria for the MUST trial are as follows:

1) Diabetes mellitus that is inadequately controlled, according to best medical judgment
2) A known allergy to a required study medication
3) Uncontrolled glaucoma
4) Advanced glaucomatous optic nerve injury meeting the following criteria:
For patients able to perform a Humphrey Visual Field:
A) Depression of two or more points within 10 degrees of fixation by at least 10 dB
and/or
B) Mean deviation worse than -15 dB
For patients unable to perform a Humphrey Visual Field
A) Vertical C/D ≥ 0.9
5) A history of scleritis (because of concerns regarding the potential for scleral melting
with local corticosteroid therapy)
6) Presence of an ocular toxoplasmosis scar
7) Pregnancy
8) Breastfeeding
9) Known human immunodeficiency virus infection or other immunodeficiency disease
for which corticosteroid therapy would be contraintraindicated according to best
medical judgment;
10) Patients for whom participation in the trial would constitute a risk exceeding the
potential benefits of study participation, in the judgment of the treating physician;
11) Medical problems or drug or alcohol dependence

E.5 End points

E.5.1

Primary end point(s)

Change in best-corrected visual acuity.

E.5.1.1

Timepoint(s) of evaluation of this end point

6.5 years

E.5.2

Secondary end point(s)

Not specified.

E.5.2.1

Timepoint(s) of evaluation of this end point

N/A.

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

Yes

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Compared to NHS standard medical treatment care

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.8.4.1

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

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

Australia

United Kingdom

United States

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 last visit of the last subject.

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

250

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)

Baush & Lomb has agreed to provide replacement implants free of charge to those patients that already have implant(s) when enrolling into this study and will continue doing so for the duration of the trial. After the completion of the trial all the patients will receive treatment that is available and considered most suitable for them.

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

2011-11-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-31

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