Trial Outcomes & Findings for Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma (NCT NCT01105065)

Results Overview

We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-04-04

Participant Flow

46 participants enrolled but only 23 had retinal vascular dysregulation.

Participant milestones

Participant milestones
Measure	Patients With RVD Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks. Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With RVD Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks. Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.
Overall Study Adverse Event	5
Overall Study Technical Problems	1

Baseline Characteristics

Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With RVD n=23 Participants Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks. Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.
Age, Continuous	57.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.

Outcome measures

Outcome measures
Measure	Patients With RVD n=17 Participants Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks. Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.	RVD Patients Post-brimonidine Treatment Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
Presence of Retinal Blood Flow Autoregulation	14 participants	—

SECONDARY outcome

Timeframe: 8 weeks

Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant.

Outcome measures

Outcome measures
Measure	Patients With RVD n=17 Participants Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks. Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.	RVD Patients Post-brimonidine Treatment n=17 Participants Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
Frequency Doubling Perimetry	-2.03 dB Standard Deviation 3.50	-2.77 dB Standard Deviation 5.03

Adverse Events

Patients With RVD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With RVD n=23 participants at risk Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks. Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.
Eye disorders Allergic reaction	21.7% 5/23

Additional Information

Louis R. Pasquale, MD

Massachusetts Eye and Ear Infirmary

Phone: 617-573-4270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place