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Completed

NCT Number: NCT00466479

Brimonidine vs ALTP in Progressing Human Glaucoma

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

sezione di Oftalmologia

Parma, 43100, Italy

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brimonidine

Drug

laser trabeculoplasty

Procedure

Primary outcomes

  1. progression of visual field measured as loss of sensitivity in decibels per year

  2. progression of visual field measured as number of eyes showing at least one cluster of points progressing

Secondary outcomes

  1. number of drop out(s) for adverse events

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

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

Important dates

Study start
1999
Study completion
2002
First posted
Apr 27, 2007
Registry last updated
Apr 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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