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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01105065
First received: April 14, 2010
Last updated: February 21, 2014
Last verified: February 2014

April 14, 2010
February 21, 2014
March 2010
December 2014   (final data collection date for primary outcome measure)
Presence or Absence of Retinal Blood Flow Autoregulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01105065 on ClinicalTrials.gov Archive Site
Improvement in Motion Detection [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma
Effect of Brimonidine 0.15% on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Tension Glaucoma

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Drug: Alphagan (brimonidine) 0.15%
One drop in each eye three times a day for 8 weeks.
Other Name: Alphagan
Experimental: Alphagan
Intervention: Drug: Alphagan (brimonidine) 0.15%
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01105065
10-03-019 (75643)
Not Provided
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Not Provided
Massachusetts Eye and Ear Infirmary
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP