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Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia (ATS14)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00789672
First received: October 27, 2008
Last updated: May 16, 2012
Last verified: May 2012

October 27, 2008
May 16, 2012
January 2009
September 2009   (final data collection date for primary outcome measure)
  • Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa [ Time Frame: 9 weeks after starting levodopa ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Tolerability of Study Medication-Adverse Event Reporting [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Number of adverse events reported throughout entire study.
Tolerability of levodopa by adverse events reported and symptom survey [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00789672 on ClinicalTrials.gov Archive Site
  • Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment [ Time Frame: 4 weeks after enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Visual acuity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia
A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amblyopia
  • Drug: levodopa/carbidopa
    Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation)
    Other Name: levodopa/carbidopa
  • Device: patching
    2 hours daily patching
    Other Name: Coverlet, 3M Opticlude, Ortopad®
  • Drug: levodopa/carbidopa
    Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)
    Other Name: levodopa/carbidopa
  • Active Comparator: Lower Dose (3-1) 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 9 weeks after starting medication.
    Interventions:
    • Device: patching
    • Drug: levodopa/carbidopa
  • Active Comparator: Higher Dose (4.5-1) levodopa/carbidopa
    Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication.
    Interventions:
    • Drug: levodopa/carbidopa
    • Device: patching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00789672
NEI-141, 2U10EY011751
Yes
Ray Kraker, Jaeb Center for Health Research
Jaeb Center for Health Research
National Eye Institute (NEI)
Study Chair: Michael X. Repka, M.D. Wilmer Eye Institute
Jaeb Center for Health Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP