Brimonidine vs ALTP in Progressing Human Glaucoma

U

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)

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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