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

NCT01105065 | Completed Results

• 1 other identifier: 10-03-019 (75643)
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have completed a study in which the investigators examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with Normal Tension Glaucoma (NTG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with NTG, this often does not occur. Upon analysis at the completion of the study , the investigators found that the patients who had been taking Alphagan (brimonidine) during the study did not exhibit the blood flow increases typical of NTG while lying down; instead, they maintained a steady blood flow rate as did the group of healthy control subjects. The investigators primary objective is to now demonstrate in a prospective study that Alphagan can restore retinal vascular autoregulatory function in patients with NTG who do not autoregulate. The investigators will also determine the effect of Alphagan treatment on the patients' ability to detect motion.

Conditions

Glaucoma

Keywords

Normal Pressure Glaucoma

Outcome Measures

Primary Outcomes (1)

• Presence of Retinal Blood Flow Autoregulation

  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%.

  8 weeks

Secondary Outcomes (1)

• Frequency Doubling Perimetry

  8 weeks

Study Arms (1)

Patients with RVD

EXPERIMENTAL

Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.

Drug: brimonidine 0.15%

Interventions

brimonidine 0.15% DRUG

One drop in each eye three times a day for 8 weeks.

Also known as: Alphagan

Patients with RVD

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects will have no history of IOP \> 24 mm Hg in either eye.
• All subjects will have open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes.
• Previously or newly diagnosed patient are required to have HVFs that are reliable and show loss consistent with nerve fiber layer atrophy.
• Patients with glaucoma-like discs (CDR\>0.7 in either eye) and normal/reliable visual fields who the PI has opted to observe without treatment will enter the study if they meet the other study criteria.
• In order to facilitate the retinal blood flow measurements, only subjects with refractive error within the range -10 to +10 diopters, no lens opacities greater than 1+ cortical spokes or 2+ nuclear sclerosis, and pupillary dilation of at least 6 mm following mydriasis will be included.

You may not qualify if:

• Patients with evidence of exfoliation or pigment dispersion syndrome in either eye.
• Patients with a cup/disc ratio \> 0.8.
• Known history of allergy to brimonidine.
• Patients already on treatment with brimonidine will be excluded from the study.
• Diabetic retinopathy.
• History of ocular laser or incisional surgery in either eye.
• Use of systemic alpha-2 blockers.
• Pregnant or planning to become pregnant.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Feke GT, Bex PJ, Taylor CP, Rhee DJ, Turalba AV, Chen TC, Wand M, Pasquale LR. Effect of brimonidine on retinal vascular autoregulation and short-term visual function in normal tension glaucoma. Am J Ophthalmol. 2014 Jul;158(1):105-112.e1. doi: 10.1016/j.ajo.2014.03.015. Epub 2014 Apr 5.

  PMID: 24709811 DERIVED

MeSH Terms

Conditions

Glaucoma; Low Tension Glaucoma

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Louis R. Pasquale, MD
• Organization: Massachusetts Eye and Ear Infirmary

Louis_Pasquale@meei.harvard.edu

617-573-4270

Study Officials

• Louis R Pasquale, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Glaucoma Service and Associate Director Telemedicine

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 16, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 4, 2017
• Results First Posted: October 27, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)