Official Title: “Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.”

This study is evaluating possible non-intraocular pressure (IOP) related effects of the alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Patients with open angle glaucoma and a history of relative stability of the visual field are followed for 18 months. A visual field is measured every 3 months for a total number of n = 6 eligible fields at the end of this phase. Then, those eyes showing progression of the field (i.e. deterioration of th eexisting glaucoma), are randomized to receive either 0.2% brimonidine tartrate eyedrops b.i.d. or 360° argon laser trabeculoplasty in one session.

Either treatment will be put "on top" of the pre-existing anti-glaucoma therapy. Then, a further 18-month phase is planned, with a sequnece of field taken at the same pace as the previous phase. Progression is detected (and measured) acording to a trend-analysis (i.e.

regression vs time of single points and of clusters of adjacent points).

Intervention(s) in this Clinical Trial

• Drug: brimonidine
• Procedure: laser trabeculoplasty

Primary Measures

• progression of visual field measured as loss of sensitivity in decibels per year
• progression of visual field measured as number of eyes showing at least one cluster of points progressing

Secondary Measures

• number of drop out(s) for adverse events

Inclusion Criteria:

• Glaucomatous visual field defect on achromatic perimetry (24/2 Humphrey full threshold,abnormal GHT and CPSD, p<0.01) considered clinically “unstable”
• IOP < 20 mmHg on repeated readings with no more than 2 medications,
• Open angle on gonioscopy,
• Glaucomatous optic neuropathy (HRTII, Moorfields regression analysis),
• Clear lens (LOCS2 score < C1, N0, P0)
• Best corrected visual acuity better than 0.2 LogMAR (ETDRS chart),
• No previous bulbar surgery
• Manifest refraction within – 5 and + 2 diopters
• No comorbidity (AMD and diabetic retinopathy.and negative history for neurological diseases)

Exclusion Criteria:

• Closed angle
• Previous bulbar surgery
• Unstable IOP
• Unreliable visual fields on historic data

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Parma

Overall Clinical Trial Officials and Contacts

stefano gandolfi, MD Principal Investigator University of Parma  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00466479

Study ID Number: PARMANP001

ClinicalTrials.gov Identifier: NCT00466479

Health Authority: Italy: Ethics Committee