NCT00432393

Brief Summary

Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in patients with recent onset NAION (less than 6 weeks duration). Patients and Methods: In this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2002

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
Last Updated

October 20, 2008

Status Verified

February 1, 2007

First QC Date

February 6, 2007

Last Update Submit

October 17, 2008

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy

Interventions

levodopa-carbidopaDRUG

Eligibility Criteria

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

You may qualify if:

  • age greater than 50 years old
  • first ophthalmic examination within 6 weeks after onset of disease
  • presence of optic disc swelling followed by optic atrophy within 6 weeks
  • altitudinal, central or generalized visual field defect
  • normal ESR

You may not qualify if:

  • confirmed giant cell arteritis
  • history of any ocular surgeries
  • optic neuropathy due to acute bleeding
  • advanced diabetic retinopathy
  • uncontrolled glaucoma
  • any ocular disorders that cause visual acuity reduction rather than NAION

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic research center

Tehran, Tehran Province, 1666694516, Iran

Location

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mohammad Pakravan, MD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 7, 2007

Study Start

June 1, 2002

Study Completion

April 1, 2003

Last Updated

October 20, 2008

Record last verified: 2007-02

Locations

IR(1)