Back to resultsBrimonidine vs ALTP in Progressing Human Glaucoma
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
brimonidine
laser trabeculoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring neuroprotection, alpha one agonists, glaucoma, visual field
Eligibility 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
Sites / Locations
- sezione di Oftalmologia
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00466479
Brief Title
Brimonidine vs ALTP in Progressing Human Glaucoma
Official Title
Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Parma
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
neuroprotection, alpha one agonists, glaucoma, visual field
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
brimonidine
Intervention Type
Procedure
Intervention Name(s)
laser trabeculoplasty
Primary Outcome Measure Information:
Title
progression of visual field measured as loss of sensitivity in decibels per year
Title
progression of visual field measured as number of eyes showing at least one cluster of points progressing
Secondary Outcome Measure Information:
Title
number of drop out(s) for adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano gandolfi, MD
Organizational Affiliation
University of Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
sezione di Oftalmologia
City
Parma
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
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Brimonidine vs ALTP in Progressing Human Glaucoma
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