Brimonidine vs ALTP in Progressing Human Glaucoma

Sponsor

University of Parma (Other)

Overall Status

Completed

CT.gov ID

NCT00466479

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: brimonidine Procedure: laser trabeculoplasty	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.

Study Start Date :

Aug 1, 1999

Actual Study Completion Date :

Oct 1, 2002

Outcome Measures

Primary Outcome 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 Outcome Measures

number of drop out(s) for adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)