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Completed

NCT Number: NCT00789672

Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 8 to < 18 years old
  • Amblyopia associated with strabismus, anisometropia, or both
  • Visual acuity in the amblyopic eye 18 to 67 letters inclusive (20/50 to 20/400)
  • Visual acuity in the sound eye ≥ 78 letters (20/25 or better)
  • Current amblyopia treatment of at least 2 hours patching per day
  • No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 4 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement of more than 4 letters or one logMAR line.

Exclusion criteria

  • Myopia more than -6.00 D (spherical equivalent) in either eye.
  • Current vision therapy or orthoptics
  • Ocular cause for reduced visual acuity
  • nystagmus per se does not exclude the subject if the above visual acuity criteria are met
  • Prior intraocular or refractive surgery
  • History of narrow-angle glaucoma
  • Strabismus surgery planned within 16 weeks
  • Known allergy to levodopa-carbidopa
  • History of dystonic reactions
  • Current requirement to take oral iron supplements including multivitamins containing iron during the 8 weeks of treatment with levodopa-carbidopa
  • Current use of antihypertensive, anti-depressant medications, phenothiazines, butyrophenones, risperidone and isoniazid, non-specific monoamine oxidase inhibitors
  • Current use of medication for the treatment of attention deficit hyperactivity disorder
  • Known gastrointestinal or liver disease
  • History of melanoma
  • Known psychological problems
  • Known skin reactions to patch or bandage adhesives
  • Prior levodopa treatment
  • Current treatment with topical atropine
  • Females who are pregnant, lactating, or intending to become pregnant within the next 16 weeks.
  • A negative urine pregnancy test will be required for all females who have experienced menarche.
  • Requirements regarding the establishment of pregnancy and monitoring of pregnancy over the course of the study as defined by each individual Institutional Review Board may supersede these criteria.

Treatment and study plan

Levodopa/carbidopa

Drug

Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation)

Patching

Device

2 hours daily patching

Other names: Coverlet, 3M Opticlude, Ortopad®

Primary outcomes

  1. 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.).

  2. 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.

  3. 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.

  4. Mean Change in Amblyopic Eye Visual Acuity Letter 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.

  5. Tolerability of Study Medication-Adverse Event Reporting

    Time frame: 24 weeks

    Number of adverse events reported throughout entire study.

Secondary outcomes

  1. 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.).

  2. 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.

  3. 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.).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Acronym: ATS14

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2008
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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