Brimonidine vs ALTP in Progressing Human Glaucoma

University of Parma

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: brimonidine

Procedure: laser trabeculoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00466479

PARMANP001

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

50 to 70 years old

Volunteers

No 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)