Trial Outcomes & Findings for Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy (NCT NCT01229410)

Last Updated: 2013-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

60 Days

Results posted on

2013-08-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	400 µg Brimonidine Tartrate Implant 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 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 Study STARTED	12	12
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	400 µg Brimonidine Tartrate Implant n=12 Participants 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 n=12 Participants 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 n=24 Participants Total of all reporting groups
Age Continuous	69.7 Years FULL_RANGE 2.87 • n=5 Participants	66.5 Years FULL_RANGE 9.67 • n=7 Participants	68.1 Years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 Days

Population: Per Protocol: all subjects with pharmacokinetic data available

Outcome measures

Outcome measures
Measure	400 µg Brimonidine Tartrate Implant n=11 Participants 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 n=12 Participants 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Highest Vitreous Humor Level of Brimonidine in the Study Eye	137.0 Nanogram/milliliter (ng/mL)	34.9 Nanogram/milliliter (ng/mL)

SECONDARY outcome

Timeframe: 60 Days

Population: Per Protocol: all subjects with pharmacokinetic data available

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.

Outcome measures

Outcome measures
Measure	400 µg Brimonidine Tartrate Implant n=12 Participants 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 n=10 Participants 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Highest Aqueous Humor Level of Brimonidine in the Study Eye	17.5 Nanogram/milliliter (ng/mL)	12.5 Nanogram/milliliter (ng/mL)

SECONDARY outcome

Timeframe: 60 Days

Population: Per Protocol: all subjects with qualified pharmacokinetic samples

Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.

Outcome measures

Outcome measures
Measure	400 µg Brimonidine Tartrate Implant n=60 Patient Samples 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 n=62 Patient Samples 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)	53.3 Percentage of Patient Samples	72.6 Percentage of Patient Samples

Adverse Events

400 µg Brimonidine Tartrate Implant

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

200 µg Brimonidine Tartrate Implant

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	400 µg Brimonidine Tartrate Implant n=12 participants at risk 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 n=12 participants at risk 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Eye disorders Choroidal Detachment	8.3% 1/12 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.	0.00% 0/12 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.
Cardiac disorders Atrial Fibrillation	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders Vitreous Haemorrhage	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Retinal Detachment	0.00% 0/12 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.	8.3% 1/12 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.

Other adverse events

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	400 µg Brimonidine Tartrate Implant n=12 participants at risk 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 n=12 participants at risk 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Eye disorders Conjunctival Haemorrhage	58.3% 7/12 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.	50.0% 6/12 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.
Eye disorders Conjunctival Hyperaemia	41.7% 5/12 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.	58.3% 7/12 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.
Eye disorders Conjunctival Oedema	16.7% 2/12 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.	16.7% 2/12 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.
Vascular disorders Hypertension	16.7% 2/12 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.	0.00% 0/12 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.
Investigations Intraocular Pressure Increased	8.3% 1/12 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.	25.0% 3/12 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.
Infections and infestations Nasopharyngitis	8.3% 1/12 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.	8.3% 1/12 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.
Eye disorders Cataract	8.3% 1/12 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.	8.3% 1/12 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.
Eye disorders Eye Pain	8.3% 1/12 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.	8.3% 1/12 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.
Cardiac disorders Atrial Fibrillation	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders Cataract Nuclear	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders Choroidal Detachment	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders Hypotony of Eye	8.3% 1/12 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.	0.00% 0/12 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.
Vascular disorders Phlebitis Superficial	8.3% 1/12 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.	0.00% 0/12 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.
Eye disorders Vitreous Haemorrhage	0.00% 0/12 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.	16.7% 2/12 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.
Eye disorders Retinal Detachment	0.00% 0/12 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.	16.7% 2/12 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.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/12 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.	8.3% 1/12 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.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Conjunctivitis	0.00% 0/12 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.	8.3% 1/12 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.
General disorders Device Dislocation	0.00% 0/12 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.	8.3% 1/12 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Visual Acuity Reduced	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Chorioretinal Disorder	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Eyelid Oedema	0.00% 0/12 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.	8.3% 1/12 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.
Investigations Intraocular Pressure Decreased	0.00% 0/12 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.	8.3% 1/12 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.
Gastrointestinal disorders Nausea	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Retinal Tear	0.00% 0/12 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.	8.3% 1/12 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.
Eye disorders Retinopathy Proliferative	0.00% 0/12 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.	8.3% 1/12 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.