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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00789672 |
This pilot study is being conducted as a prelude to a randomized trial. 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, and to provide limited data on its safety. In addition, this study will address whether oral levodopa with patching improves the visual acuity of subjects with residual amblyopia and provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.
Condition | Intervention | Phase |
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Amblyopia |
Drug: levodopa/carbidopa Device: Patching |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds |
Estimated Enrollment: | 30 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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levodopa/carbidopa
Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
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Drug: levodopa/carbidopa
Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)
Device: Patching
2 hours daily patching
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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.
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Ocular cause for reduced visual acuity
• nystagmus per se does not exclude the subject if the above visual acuity criteria are met
Females who are pregnant, lactating, or intending to become pregnant within the next 16 weeks.
Contact: Raymond T. Kraker, M.S.P.H. | 813-975-8690 | pedig@jaeb.org |
Contact: Heidi A. Gillespie | 813-975-8690 | pedig@jaeb.org |
United States, Maryland | |
Wilmer Eye Institute | |
Baltimore, Maryland, United States, 21287 |
Study Chair: | Michael X. Repka, M.D. | Wilmer Eye Institute |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director ) |
Study ID Numbers: | NEI-141 |
Study First Received: | October 27, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00789672 |
Health Authority: | United States: Food and Drug Administration |
Amblyopia Patching Levodopa |
Signs and Symptoms Sensation Disorders Levodopa Dopamine Vision Disorders Amblyopia |
Eye Diseases Carbidopa Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Enzyme Inhibitors Central Nervous System Agents Pharmacologic Actions |