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Sponsored by: |
University of Parma |
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Information provided by: | University of Parma |
ClinicalTrials.gov Identifier: | NCT00466479 |
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 |
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Glaucoma |
Drug: brimonidine Procedure: laser trabeculoplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial. |
Estimated Enrollment: | 50 |
Study Start Date: | August 1999 |
Study Completion Date: | October 2002 |
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).
Ages Eligible for Study: | 50 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PARMANP001 |
Study First Received: | April 26, 2007 |
Last Updated: | April 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00466479 |
Health Authority: | Italy: Ethics Committee |
neuroprotection alpha one agonists glaucoma visual field |
Glaucoma Eye Diseases Brimonidine Hypertension Ocular Hypertension |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Adrenergic Agonists |