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CompletedNCT00789672ATS14Updated Jul 13, 2016Results posted

Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

A Phase 2 interventional study of levodopa/carbidopa and patching in Amblyopia, sponsored by Jaeb Center for Health Research. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Jaeb Center for Health Research · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
8 Years to 17 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Amblyopia

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Keywords

  • Amblyopia
  • Patching
  • Levodopa
03

In context

Amblyopia

183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 133 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • 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.

    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.

    Drug: levodopa/carbidopa · Device: patching

Interventions

  • Druglevodopa/carbidopa

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

  • Devicepatching

    2 hours daily patching

    Also known as: Coverlet, 3M Opticlude, Ortopad®

  • Druglevodopa/carbidopa

    Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)

06

What researchers measure

Primary outcomes

  1. Distribution of Amblyopic Eye Visual Acuity Letter Scores at 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.).

    Time frame: 9 weeks after starting levodopa

  2. Mean Amblyopic Eye Visual Acuity Letter Scores at 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.

    Time frame: 9 weeks after starting levodopa

  3. Distribution of Change in Amblyopic Eye Visual Acuity Scores at 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 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Time frame: baseline to 9 weeks

  4. Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 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 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Time frame: baseline to 9 weeks

  5. Tolerability of Study Medication-Adverse Event Reporting

    Number of adverse events reported throughout entire study.

    Time frame: 24 weeks

Secondary outcomes

  1. Distribution of Amblyopic Eye Visual Acuity Letter Scores at 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.).

    Time frame: 4 weeks after enrollment

  2. Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post 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.

    Time frame: 4 weeks after enrollment

  3. Distribution of Amblyopic Eye Visual Acuity Letter Scores at 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.).

    Time frame: 10 weeks after stopping levodopa

  4. Mean Amblyopic Eye Visual Acuity Letter Scores at 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.

    Time frame: 10 weeks after stopping levodopa

  5. Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post 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. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Time frame: enrollment to 4 weeks

  6. Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post 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. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Time frame: enrollment to 4 weeks

  7. Distribution of Change in Amblyopic Eye Visual Acuity Scores at 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.

    Time frame: baseline to 10 weeks after stopping levodopa

  8. Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 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.

    Time frame: baseline to 10 weeks after stopping levodopa

07

Results

Posted Mar 23, 2011
Limitations and caveats
Without a patching-only control group, no conclusions can be made regarding efficacy, safety, or side effects with this treatment. Placebo controlled trial is needed to see if levodopa can augment occlusion therapy in the treatment of amblyopia.

Participant flow

Eligibility criteria included age 8 to \<18 years, best-corrected visual acuity in the amblyopic eye between 67 and 18 letters inclusive measured with E-ETDRS, fellow eye best-corrected visual acuity of 78 letters or better, and the presence or history of strabismus and/or anisometropia.

Participant flow — Overall Study
MilestoneLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Started1617
Completed1617
Not completed00

Outcome measures

PrimaryDistribution of Amblyopic Eye Visual Acuity Letter Scores at 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.).

Time frame:
9 weeks after starting levodopa
Reported as:
Number · participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
participantsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
<20/100 (<47 letters)25
20/100 (47 to 52 letters)20
20/80 (53 to 57)11
20/63 (58 to 62)35
20/50 (63 to 67)43
20/40 (68-72 letters)32
20/32 (73 to 77 letters)11
PrimaryMean Amblyopic Eye Visual Acuity Letter Scores at 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.

Time frame:
9 weeks after starting levodopa
Reported as:
Mean · letters
Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
lettersLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa59.9 ± 9.756.5 ± 12.7
PrimaryDistribution of Change in Amblyopic Eye Visual Acuity Scores at 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 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

Time frame:
baseline to 9 weeks
Reported as:
Number · participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa
participantsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
>=15 letters worse00
10 to 14 letters worse00
5 to 9 letters worse01
Within plus or minus 4 letters95
5 to 9 letters better56
10 to 14 letters better24
>=15 letters better01
SecondaryDistribution of Amblyopic Eye Visual Acuity Letter Scores at 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.).

Time frame:
4 weeks after enrollment
Reported as:
Number · participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment
participantsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
<20/100 (<47 letters)24
20/100 (47 to 52 letters)21
20/80 (53 to 57)13
20/63 (58 to 62)45
20/50 (63 to 67)43
20/40 (68-72 letters)31
20/32 (73 to 77 letters)00
SecondaryMean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post 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.

Time frame:
4 weeks after enrollment
Reported as:
Mean · letters
Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment
lettersLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment59.1 ± 9.254.3 ± 12.9
SecondaryDistribution of Amblyopic Eye Visual Acuity Letter Scores at 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.).

Time frame:
10 weeks after stopping levodopa
Reported as:
Number · participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
participantsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
<20/100 (<47 letters)25
20/100 (47 to 52 letters)01
20/80 (53 to 57)32
20/63 (58 to 62)43
20/50 (63 to 67)26
20/40 (68-72 letters)10
20/32 (73 to 77 letters)30
SecondaryMean Amblyopic Eye Visual Acuity Letter Scores at 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.

Time frame:
10 weeks after stopping levodopa
Reported as:
Mean · letters
Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
lettersLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa60.6 ± 11.153.9 ± 11.4
PrimaryMean Change in Amblyopic Eye Visual Acuity Letter Scores at 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 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

Time frame:
baseline to 9 weeks
Reported as:
Mean · letters
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
lettersLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa3.8 ± 3.56.1 ± 5.6
Statistical analysis
  • Lower Dose 0.51 mg Levodopa/Carbidopa vs Higher Dose 0.76 mg Levodopa/Carbidopa · Mean difference (final values): -2 · 95% CI -6 to 1
PrimaryTolerability of Study Medication-Adverse Event Reporting

Number of adverse events reported throughout entire study.

Time frame:
24 weeks
Reported as:
Number · events
Tolerability of Study Medication-Adverse Event Reporting
eventsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Headache66
Cold/Upper Respiratory Infection/Cough36
Rash13
Flu21
Nausea/Vomiting21
Fatigue/Sleepiness31
Dizziness/light-headedness30
Conjunctivitis02
Muscle pain02
Stomach ache02
Ear ache10
Fever10
Loss of appetite20
Nightmare10
Knee injury10
Sinus infection10
Weight loss10
Constipation10
Finger injury01
Pulled muscle01
SecondaryDistribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post 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. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

Time frame:
enrollment to 4 weeks
Reported as:
Number · participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment
participantsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
>=15 letters worse00
10 to 14 letters worse00
5 to 9 letters worse00
Within plus or minus 4 letters119
5 to 9 letters better57
10 to 14 letters better01
>=15 letters better00
SecondaryMean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post 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. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

Time frame:
enrollment to 4 weeks
Reported as:
Mean · letters
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment
lettersLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment2.9 ± 2.83.8 ± 3.6
SecondaryDistribution of Change in Amblyopic Eye Visual Acuity Scores at 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.

Time frame:
baseline to 10 weeks after stopping levodopa
Reported as:
Number · participants
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa
participantsLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
>=15 letters worse00
10 to 14 letters worse00
5 to 9 letters worse01
Within plus or minus 4 letters78
5 to 9 letters better67
10 to 14 letters better21
>=15 letters better00
SecondaryMean Change in Amblyopic Eye Visual Acuity Letter Scores at 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.

Time frame:
baseline to 10 weeks after stopping levodopa
Reported as:
Mean · letters
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
lettersLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa4.9 ± 3.73.5 ± 4.7

Adverse events

Collected over Up to 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lower Dose 0.51 mg Levodopa/Carbidopa—0/16 (0%)8/16 (50%)
Higher Dose 0.76 mg Levodopa/Carbidopa—0/17 (0%)11/17 (64.7%)
Most frequent other events
Showing 10 of 20
Most frequent other events
EventLower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/Carbidopa
HeadacheGeneral disorders3/163/17
Cold/Upper Respiratory Infection/CoughRespiratory, thoracic and mediastinal disorders3/163/17
RashSkin and subcutaneous tissue disorders1/163/17
FluGeneral disorders2/161/17
Nausea/VomitingGastrointestinal disorders2/161/17
Fatique/SleepinessGeneral disorders2/161/17
Stomache AcheGastrointestinal disorders0/162/17
Dizziness/Light-headednessGeneral disorders1/160/17
Ear AcheEar and labyrinth disorders1/160/17
FeverGeneral disorders1/160/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
Mean11.3 ± 2.211.0 ± 2.211.1 ± 2.2
Age, Customized
Age, Customized(participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
8 to <9336
9 to <10235
10 to <11347
11 to <12314
12 to <13033
13 to <14314
14 to <15202
15 to <16022
16 to <17000
17 to <18000
Sex: Female, Male
Sex: Female, Male(Participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
Female10919
Male6814
Region of Enrollment
Region of Enrollment(participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
United States161733
Cause of Amblyopia
Cause of Amblyopia(participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
Strabismus257
Anisometropia6511
Strabismus and anisometropia8715
Distance Visual Acuity in Amblyopic Eye
Distance Visual Acuity in Amblyopic Eye(participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
20/400 (18 to 22 letters)011
20/320 (23 to 27 letters)000
20/250 (28 to 32 letters)011
20/200 (33 to 37 letters)112
20/160 (38 to 42 letters)112
20/125 (43 to 47 letters)011
20/100 (48 to 52 letters)202
20/80 (53 to 57 letters)4610
20/63 (58 to 62 letters)459
20/50 (63 to 67 letters)415
Distance Visual Acuity in Fellow Eye
Distance Visual Acuity in Fellow Eye(participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
20/25 (78 to 82 letters)448
20/20 (83 to 87 letters)6814
20/16 (88 to 92 letters)5510
20/12 (93 to 97 letters)101
Race/Ethnicity
Race/Ethnicity(participants)Lower Dose 0.51 mg Levodopa/CarbidopaHigher Dose 0.76 mg Levodopa/CarbidopaTotal
White141731
African-American101
Hispanic or Latino101
Asian000
More than one race000
Unknown/Not reported000

8 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Wilmer Eye Institute
    Baltimore, Maryland 21287, United States
09

References and documents

Publications

  • Repka MX, Kraker RT, Beck RW, Atkinson CS, Bacal DA, Bremer DL, Davis PL, Gearinger MD, Glaser SR, Hoover DL, Laby DM, Morrison DG, Rogers DL, Sala NA, Suh DW, Wheeler MB; Pediatric Eye Disease Investigator Group. Pilot study of levodopa dose as treatment for residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol. 2010 Sep;128(9):1215-7. doi: 10.1001/archophthalmol.2010.178. No abstract available. PubMed 20837811 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00789672
Lead sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI)
Responsible party
Ray Kraker (Director, PEDIG Coordinating Center, Jaeb Center for Health Research) — Principal investigator
First posted
Nov 13, 2008
Start date
Jan 2009
Primary completion
Sep 2009
Completion
Dec 2009
Results posted
Mar 23, 2011
Last update
Jul 13, 2016

Study contacts

Michael X. Repka, M.D.
study chair · Wilmer Eye Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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