NCT00466479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 1999

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

April 26, 2007

Last Update Submit

April 26, 2007

Conditions

Glaucoma

Keywords

neuroprotectionalpha one agonistsglaucomavisual field

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • number of drop out(s) for adverse events

Interventions

brimonidineDRUG
laser trabeculoplastyPROCEDURE

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Closed angle
  • Previous bulbar surgery
  • Unstable IOP
  • Unreliable visual fields on historic data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sezione di Oftalmologia

Parma, 43100, Italy

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • stefano gandolfi, MD

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

August 1, 1999

Study Completion

October 1, 2002

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

IT(1)