Clinical Trials Register

Summary
EudraCT Number:	2009-015586-31
Sponsor's Protocol Code Number:	190342-031D
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:	2010-03-17
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

2009-015586-31

A.3

Full title of the trial

A Multicenter, Masked, Randomized, Sham-Controlled, Parallel-Group, 3 Month Study with a 9-Month Safety Extension to Evaluate the Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS®) Applicator System in Improving Visual Function in Patients with a Previous Rhegmatogenous Macula-Off Retinal Detachment

A.4.1

Sponsor's protocol code number

190342-031D

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator System
D.3.2	Product code	9742X
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Brimonidine Tartrate
D.3.9.1	CAS number	70359-46-5
D.3.9.2	Current sponsor code	AGN 190342-LF
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	200
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator System
D.3.2	Product code	9741X
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Brimonidine Tartrate
D.3.9.1	CAS number	70359-46-5
D.3.9.2	Current sponsor code	AGN 190342-LF
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	400
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Implant
D.8.4	Route of administration of the placebo	Intravitreal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Rhegmatogenous Macula-off Retinal Detachment

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10065569
E.1.2	Term	Rhegmatogenous retinal detachment

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 efficacy of the Brimo PS DDS® Applicator System (200 µg and 400 µg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment

To evaluate the safety of the Brimo PS DDS® Applicator System (200 µg and 400 µg brimonidine tartrate) in patients with previous rhegmatogenous macula-off retinal detachment

E.2.2

Secondary objectives of the trial

N/A

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female age ≥ 18 years
2. The macula-off retinal detachment (including fovea) must have been rhegmatogenous in etiology; no suspected combined mechanism is permitted in the study eye
3. The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
4. No evidence of macular detachment or macular edema on screening optical coherence tomography (OCT) in the study eye
5. The best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score must be ≥ 24 letters (ie, approximately 20/320 or better) and ≤ 65 letters (ie, approximately 20/50 or worse) in the study eye at screening and Day 1 and, in the opinion of the investigator, the decreased visual acuity is due to rhegmatogenous macula-off (including fovea) retinal detachment
6. The best-corrected ETDRS visual acuity in the non-study eye at screening is ≥ 24 letters (approximately 20/320 or better)
7. The repair of the detachment must have been deemed an anatomic success, and must have required no more than one macular re-attachment procedure (at least 6 months before the Day 1 visit) in the study eye
8. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate clinical evaluation of posterior pole and for adequate visualization of DDS® in the study eye
9. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment on Day 1. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilized
10. Written informed consent has been obtained
11. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
12. Written Data Protection Consent (European sites only) has been obtained
13. Written documentation has been obtained in accordance with state and country privacy requirements, where applicable
14. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures

E.4

Principal exclusion criteria

1. Any sight-threatening ocular condition in the study eye other than RRD such as age-related macular degeneration, proliferative vitreo-retinopathy, moderate to severe diabetic retinopathy, epiretinal membrane or glaucoma requiring treatment that can interfere with the diagnosis or the assessment of disease progression or in the opinion of the investigator would prevent a 15-letter improvement in visual acuity
2. Silicone oil in the vitreous cavity of the study eye
3. Residual subretinal fluid in the macula or macular edema in the study eye by OCT or clinical exam
4. Cataract in the study eye defined as likely to:
a. require cataract surgery during the study or
b. contribute to worsening BCVA during the study or
c. prevent a 3-line improvement
5. Aphakia or presence of anterior chamber intraocular lens in the study eye
6. Anticipated need for ocular surgery in the study eye during the 12-month study period
7. Any injectable, periocular, or intravitreal corticosteroid treatment to the study eye within 6 months prior to screening (eg, triamcinolone acetonide) or any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
8. Any infectious condition in the study eye
9. Use of brimonidine, apraclonidine, or any other topical alpha-2 agonist in the study eye within 2 weeks prior to the screening visit or anticipated use during the study
10. Use of systemic alpha-2 antagonists (eg, phentolamine, phenoxybenzamine, yohimbine, idazoxan) or systemic alpha-2 agonists (eg, clonidine) within 2 weeks prior to the screening visit or anticipated use during the study
11. Sight-threatening disease in the non study eye
12. Known allergy to brimonidine tartrate or any component of the delivery vehicle or diagnostic agents used during the study (eg, dilation drops).
13. Contraindication to pupil dilation in either eye
14. Uncontrolled systemic disease
15. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
16. Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient’s ability to comply with study requirements including completion of the study
17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to the screening visit
18. Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

E.5 End points

E.5.1

Primary end point(s)

Efficacy measures:
Primary efficacy measure: BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] method)
Other efficacy measures: reading speed (selected sites), Humphrey visual field (selected sites), microperimetry (selected sites), and sweep visual evoked potential (VEP) (optional at selected sites)
Other prognostic measures: Stratus optical coherence tomography (OCT), Fourier Domain OCT (selected sites)
Health outcome measures: vision-related quality of life (patient-reported outcomes) using the National Eye Institute 25-Item Visual Functioning Questionnaire (NEI-VFQ-25)

Safety measures:
Adverse events, BCVA by ETDRS, reading speed (selected sites), biomicroscopy, intraocular pressure (IOP), indirect ophthalmoscopy, vital signs (blood pressure, pulse, respiration), DDS® residual assessment

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Sham applicator

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

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

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

Last subject last visit

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.1.3

Elderly (>=65 years)

Yes

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Subjects have very poor vision, and may be unable to read

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)

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.

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

2009-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-01-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-07-18

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