Brimonidine vs ALTP in Progressing Human Glaucoma - Full Text View

Sponsor:	University of Parma
Information provided by:	University of Parma
ClinicalTrials.gov Identifier:	NCT00466479

Purpose

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	Intervention	Phase
Glaucoma	Drug: brimonidine Procedure: laser trabeculoplasty	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by University of Parma:

Primary Outcome Measures:

progression of visual field measured as loss of sensitivity in decibels per year
progression of visual field measured as number of eyes showing at least one cluster of points progressing

Secondary Outcome Measures:

number of drop out(s) for adverse events

Estimated Enrollment:	50
Study Start Date:	August 1999
Study Completion Date:	October 2002

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).

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466479

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00466479 History of Changes
Other Study ID Numbers:	PARMANP001
Study First Received:	April 26, 2007
Last Updated:	April 26, 2007
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Parma:

neuroprotection
alpha one agonists
glaucoma
visual field

Additional relevant MeSH terms:

Glaucoma
Ocular Hypertension
Eye Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012