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Brimonidine vs ALTP in Progressing Human Glaucoma

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

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466479


Locations
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Italy
sezione di Oftalmologia
Parma, Italy, 43100
Sponsors and Collaborators
University of Parma
Investigators
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Principal Investigator: stefano gandolfi, MD University of Parma

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ClinicalTrials.gov Identifier: NCT00466479     History of Changes
Other Study ID Numbers: PARMANP001
First Posted: April 27, 2007    Key Record Dates
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:
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Brimonidine Tartrate
Glaucoma
Ocular Hypertension
Eye Diseases
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