Clinical Trial: Levodopa for the Treatment of Residual Amblyopia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Trial of Levodopa as Treatment for Residual Amblyopia (ATS 17)

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.

Detailed Summary:

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study where children 7 to 12 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

Many clinicians have recognized that conventional therapies with patching and atropine have not been universally successful and have sought alternatives. PEDIG has discussed for several years the problem of residual amblyopia and how the remaining visual acuity deficit could be reduced. A number of research groups have evaluated the short term use of oral levodopa-carbidopa as an adjunct to patching therapy for older children.

Current Primary Outcome:

• Distribution of Amblyopic Eye Visual Acuity Change From Baseline [ Time Frame: 18 weeks after enrollment ]

  The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.

  Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

• Mean Amblyopic Eye Visual Acuity Change From Baseline [ Time Frame: 18 weeks after enrollment ]

  The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.

  Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

Original Primary Outcome: Amblyopic Eye Visual Acuity [ Time Frame: 18 weeks after enrollment ]

Current Secondary Outcome:

• Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks [ Time Frame: 18 weeks after enrollment ]
  Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.
• Distribution of Amblyopic Eye Visual Acuity at 18 Weeks [ Time Frame: 18 weeks after enrollment ]
• Mean Amblyopic Eye Visual Acuity at 18 Weeks [ Time Frame: 18 weeks after enrollment ]
  Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
• Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks [ Time Frame: 4 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
• Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks [ Time Frame: 10 weeks after enrollment ]
  Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.
• Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks [ Time Frame: 16 weeks after enrollment ]
  Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.
• Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks [ Time Frame: 26 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
• Amblyopia Resolutionat 4 Weeks [ Time Frame: 4 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
• Amblyopia Resolution at 10 Weeks [ Time Frame: 10 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
• Amblyopia Resolution at 16 Weeks [ Time Frame: 16 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
• Amblyopia Resolution at 18 Weeks [ Time Frame: 18 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
• Amblyopia Resolution at 26 Weeks [ Time Frame: 26 weeks after enrollment ]
  Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
• Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks [ Time Frame: 4 weeks after enrollment ]
  Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
• Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks [ Time Frame: 4 weeks after enrollment ]
  A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.
• Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks [ Time Frame: 10 weeks after enrollment ]
  Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
• Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks [ Time Frame: 10 weeks after enrollment ]
  A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
• Di
  
  

  Original Secondary Outcome:

  • Visual Acuity Improvement [ Time Frame: 18 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
  • Amblyopia Resolution [ Time Frame: 18 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
  • Visual Acuity Improvement [ Time Frame: 4 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
  • Visual Acuity Improvement [ Time Frame: 10 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
  • Visual Acuity Improvement [ Time Frame: 16 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
  • Visual Acuity Improvement [ Time Frame: 26 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
  • Amblyopia Resolution [ Time Frame: 4 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
  • Amblyopia Resolution [ Time Frame: 10 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
  • Amblyopia Resolution [ Time Frame: 16 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
  • Amblyopia Resolution [ Time Frame: 26 weeks after enrollment ]
    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.
  • Adverse Event [ Time Frame: 26 weeks after enrollment ]
    The proportion of subjects reporting at least one adverse event will be compared between treatment groups using Fisher's Exact test.
  • Study Related Adverse Event [ Time Frame: 26 weeks after enrollment ]
    The proportion of subjects reporting at least one adverse event thought by investigator to be related to study drug will be compared between treatment groups using Fisher's Exact test.
  • Adverse Event Requiring Drug Discontinuation [ Time Frame: 26 weeks after enrollment ]
    The proportion of subjects who stopped study drug in response to an adverse event will be compared between treatment groups using Fisher's Exact test.
  • Amblyopic Eye Visual Acuity [ Time Frame: 4 weeks after enrollment ]
    A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.
  • Amblyopic Eye Visual Acuity [ Time Frame: 10 weeks after enrollment ]
    A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity.
  • Amblyopic Eye Visual Acuity [ Time Frame: 16 weeks after enrollment ]
    A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, adjusted for baseline acuity.
  • Amblyopic Eye Visual Acuity [ Time Frame: 26 weeks after enrollment ]
    A treatment group comparison of the mean amblyopic eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity.
  • Fellow Eye Visual Acuity [ Time Frame: 18 weeks after enrollment ]
    Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the me
    
    Information By: Jaeb Center for Health Research
    

    Dates:
    Date Received: August 17, 2010
    Date Started: September 2010
    Date Completion:
    Last Updated: May 3, 2016
    Last Verified: May 2016
    

    

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