Clinical Trial: Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

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

Official Title: A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds

Brief Summary: This pilot study is being conducted as a prelude to a randomized trial to compare levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to demonstrate recruitment potential, to provide prospective data on the tolerability of levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide limited data on it's efficiency, and to provide data to assist in selecting a dose to use in a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.

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 (ATS3) where children 7 to 13 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.
Sponsor: Jaeb Center for Health Research

Current Primary Outcome:

  • Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa [ Time Frame: 9 weeks after starting levodopa ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).
  • Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa [ Time Frame: 9 weeks after starting levodopa ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
  • Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa [ Time Frame: baseline to 9 weeks ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
  • Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa [ Time Frame: baseline to 9 weeks ]
  • Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment [ Time Frame: 4 weeks after enrollment ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).
  • Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment [ Time Frame: 4 weeks after enrollment ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.
  • Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa [ Time Frame: 10 weeks after stopping levodopa ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).
  • Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa [ Time Frame: 10 weeks after stopping levodopa ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.
  • Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment [ Time Frame: enrollment to 4 weeks ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
  • Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment [ Time Frame: enrollment to 4 weeks ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
  • Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa [ Time Frame: baseline to 10 weeks after stopping levodopa ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
  • Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa [ Time Frame: baseline to 10 weeks after stopping levodopa ]
    Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.


Original Secondary Outcome: Visual acuity [ Time Frame: 16 weeks ]

Information By: Jaeb Center for Health Research

Dates:
Date Received: October 27, 2008
Date Started: January 2009
Date Completion:
Last Updated: July 7, 2016
Last Verified: July 2016