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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	16 February 2015
Main ID:	EUCTR2010-019079-32-PT
Date of registration:	05/04/2010
Prospective Registration:	Yes
Primary sponsor:	Allergan Limited
Public title:	A Multicenter, Patient-Masked, Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Scientific title:	A Multicenter, Patient-Masked, Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Date of first enrolment:	19/05/2010
Target sample size:	290
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019079-32
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Sham applicator
Phase:

Countries of recruitment
Czech Republic	Germany	Italy	Portugal	United Kingdom

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
1. Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
2. Written informed consent has been obtained
3. Written Authorization for Use and Release of Health and Research Study
Information (US sites only) has been obtained
4. Written Data Protection Consent (European sites only) has been obtained
5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
6. Willing to follow instructions and likely to complete all required visits
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Exclusion criteria:
n/a

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients who participated in a previous intravitreal Brimo PS DDS study, including 190342-028D (Retinitis pigmentosa) and 190342-032D (Geographic Atrophy from Age-related Macular Degeneration).

Intervention(s)

Product Name: Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator System
Product Code: 9715X
Pharmaceutical Form: Implant
INN or Proposed INN: Brimonidine Tartrate
CAS Number: 70359-46-5
Current Sponsor code: AGN 190342-LF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Intravitreal use

Product Name: Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator System
Product Code: 9742X
Pharmaceutical Form: Implant
INN or Proposed INN: Brimonidine Tartrate
CAS Number: 70359-46-5
Current Sponsor code: AGN 190342-LF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Intravitreal use

Product Name: Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS) Applicator System
Product Code: 9741X
Pharmaceutical Form: Implant
INN or Proposed INN: Brimonidine Tartrate
CAS Number: 70359-46-5
Current Sponsor code: AGN 190342-LF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Intravitreal use

Primary Outcome(s)

Main Objective: To evaluate the biodegradation and related safety profile of the intravitreal Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS®) Implant

Primary end point(s): Safety Measures:
• Adverse events
• Vital signs (blood pressure, pulse, respiration)
• Manifest refraction and BCVA by ETDRS
• Biomicroscopic examination
• IOP
• Indirect ophthalmoscopic examination
• DDS® residual assessment
• Photograph of the implant if visible

Secondary Objective: n/a

Secondary Outcome(s)

Secondary ID(s)

190342-033D

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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