Brimonidine vs ALTP in Progressing Human Glaucoma

• ClinicalTrials.gov Identifier: NCT00466479
• Recruitment Status: Completed
• First Posted: April 27, 2007
• Last Update Posted: April 27, 2007
• Sponsor: University of Parma
• Information provided by: University of Parma

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 (Clinical Trial)
• Enrollment: 50 participants
• 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: August 1999
• Actual Study Completion Date: October 2002

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Italy

sezione di Oftalmologia

Parma, Italy, 43100

Sponsors and Collaborators

University of Parma

Investigators

• Principal Investigator: stefano gandolfi, MD; University of Parma

More Information

• ClinicalTrials.gov Identifier: NCT00466479
• Other Study ID Numbers: PARMANP001
• First Posted: April 27, 2007
• Last Update Posted: April 27, 2007
• Last Verified: April 2007

Keywords provided by University of Parma:

neuroprotection; alpha one agonists; glaucoma; visual field

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases; Brimonidine Tartrate; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs