Brimonidine vs ALTP in Progressing Human Glaucoma

Phase 4

Completed

• Conditions: Glaucoma

• Registration Number: NCT00466479
• Lead Sponsor: University of Parma

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 1999-08
• Study Completion: 2002-10
• Status Verified: 2007-04
• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-26
• Last Update Submitted: 2007-04-26
• Study First Posted: 2007-04-27
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
number of drop out(s) for adverse events

Trial Locations

Locations (1)

sezione di Oftalmologia; 🇮🇹 Parma, Italy