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Trial record 4 of 152 for:    Brimonidine

Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

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ClinicalTrials.gov Identifier: NCT01229410
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Vitrectomy
Interventions Drug: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant
Enrollment 24
Recruitment Details  
Pre-assignment Details Patients were enrolled in groups by planned time of pars plana vitrectomy (Week 2, 4, or 8 post-implant). Patients who had the implant removed during the vitrectomy did not complete the 6 month follow-up per protocol.
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Hide Arm/Group Description 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Period Title: Overall Study
Started 12 12
Completed 7 9
Not Completed 5 3
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant Total
Hide Arm/Group Description 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
69.7
(64 to 75)
66.5
(53 to 78)
68.1
(53 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
8
  66.7%
6
  50.0%
14
  58.3%
Male
4
  33.3%
6
  50.0%
10
  41.7%
1.Primary Outcome
Title Highest Vitreous Humor Level of Brimonidine in the Study Eye
Hide Description The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.
Time Frame 60 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol: all subjects with pharmacokinetic data available
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Hide Arm/Group Description:
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: Nanogram/milliliter (ng/mL)
137.0 34.9
2.Secondary Outcome
Title Highest Aqueous Humor Level of Brimonidine in the Study Eye
Hide Description The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.
Time Frame 60 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol: all subjects with pharmacokinetic data available
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Hide Arm/Group Description:
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: Nanogram/milliliter (ng/mL)
17.5 12.5
3.Secondary Outcome
Title Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)
Time Frame 60 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol: all subjects with qualified pharmacokinetic samples
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Hide Arm/Group Description:
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Overall Number of Participants Analyzed 11 11
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Samples
60 62
Measure Type: Number
Unit of Measure: Percentage of Patient Samples
53.3 72.6
Time Frame [Not Specified]
Adverse Event Reporting Description For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of the eye.
 
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Hide Arm/Group Description 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
All-Cause Mortality
400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   2/12 (16.67%) 
Cardiac disorders     
Atrial Fibrillation  1  1/12 (8.33%)  0/12 (0.00%) 
Eye disorders     
Choroidal Detachment  1  1/12 (8.33%)  0/12 (0.00%) 
Vitreous Haemorrhage  1  0/12 (0.00%)  1/12 (8.33%) 
Retinal Detachment  1  0/12 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant
Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   12/12 (100.00%) 
Cardiac disorders     
Atrial Fibrillation  1  1/12 (8.33%)  0/12 (0.00%) 
Eye disorders     
Conjunctival Haemorrhage  1  7/12 (58.33%)  6/12 (50.00%) 
Conjunctival Hyperaemia  1  5/12 (41.67%)  7/12 (58.33%) 
Conjunctival Oedema  1  2/12 (16.67%)  2/12 (16.67%) 
Cataract  1  1/12 (8.33%)  1/12 (8.33%) 
Eye Pain * 1  1/12 (8.33%)  1/12 (8.33%) 
Cataract Nuclear  1  1/12 (8.33%)  0/12 (0.00%) 
Choroidal Detachment  1  1/12 (8.33%)  0/12 (0.00%) 
Hypotony of Eye  1  1/12 (8.33%)  0/12 (0.00%) 
Vitreous Haemorrhage  1  0/12 (0.00%)  2/12 (16.67%) 
Retinal Detachment  1  0/12 (0.00%)  2/12 (16.67%) 
Conjunctivitis  1  0/12 (0.00%)  1/12 (8.33%) 
Visual Acuity Reduced * 1  0/12 (0.00%)  1/12 (8.33%) 
Chorioretinal Disorder  1  0/12 (0.00%)  1/12 (8.33%) 
Eyelid Oedema * 1  0/12 (0.00%)  1/12 (8.33%) 
Retinal Tear  1  0/12 (0.00%)  1/12 (8.33%) 
Retinopathy Proliferative  1  0/12 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders     
Nausea * 1  0/12 (0.00%)  1/12 (8.33%) 
General disorders     
Device Dislocation * 1  0/12 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Nasopharyngitis  1  1/12 (8.33%)  1/12 (8.33%) 
Investigations     
Intraocular Pressure Increased  1  1/12 (8.33%)  3/12 (25.00%) 
Intraocular Pressure Decreased  1  0/12 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders     
Hyperlipidaemia  1  0/12 (0.00%)  1/12 (8.33%) 
Hyperuricaemia  1  0/12 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/12 (0.00%)  1/12 (8.33%) 
Vascular disorders     
Hypertension  1  2/12 (16.67%)  0/12 (0.00%) 
Phlebitis Superficial  1  1/12 (8.33%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229410     History of Changes
Other Study ID Numbers: 190342-036
First Submitted: October 20, 2010
First Posted: October 27, 2010
Results First Submitted: March 13, 2013
Results First Posted: August 5, 2013
Last Update Posted: August 5, 2013