Brimonidine vs ALTP in Progressing Human Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Study Completion Date

2002-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Glaucoma

Keywords

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neuroprotection alpha one agonists glaucoma visual field

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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brimonidine

Intervention Type DRUG

laser trabeculoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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stefano gandolfi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

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sezione di Oftalmologia

Parma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PARMANP001

Identifier Type: -

Identifier Source: org_study_id