Brimonidine vs ALTP in Progressing Human Glaucoma

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466479
• Other study ID #: PARMANP001
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2007
• Last updated: April 26, 2007
• Start date: August 1999
• Est. completion date: October 2002

Study information

• Verified date: April 2007
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• brimonidine

Procedure:
• laser trabeculoplasty

Locations

Country	Name	City	State
Italy	sezione di Oftalmologia	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression of visual field measured as loss of sensitivity in decibels per year
Primary	progression of visual field measured as number of eyes showing at least one cluster of points progressing
Secondary	number of drop out(s) for adverse events