Levodopa for the Treatment of Residual Amblyopia

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01190813
• Date of registration: 17/08/2010
• Primary sponsor: Jaeb Center for Health Research
• Public title: Levodopa for the Treatment of Residual Amblyopia ATS17
• Scientific title: A Randomized Trial of Levodopa as Treatment for Residual Amblyopia (ATS 17)
• Date of first enrolment: September 2010
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01190813
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael X Repka, MD

• Name: Ray Kraker, MSPH

• Name: Michael X Repka, MD
• Affiliation: Jaeb Center for Health Research

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 7 to 12

2. Amblyopia associated with strabismus, anisometropia, or both

- Criteria for strabismus: One of the following criteria must be met:
Heterotropia at distance and/or near fixation on examination (with or without
spectacles); History of strabismus surgery; Documented history of strabismus
which is no longer present (which in the judgment of the investigator could have
caused amblyopia)

- Criteria for anisometropia: One of the following criteria must be met: =0.50 D
difference between eyes in spherical equivalent; =1.50 D difference between eyes
in astigmatism in any meridian

3. Visual acuity, measured in each eye (amblyopic eye without cycloplegia) within 7 days
prior to enrollment using the E-ETDRS protocol by a study certified visual acuity
tester as follows:

- Visual acuity in the amblyopic eye 18 to 67 letters inclusive (20/50 to 20/400)

- Visual acuity in the fellow eye =78 letters (20/25 or better)

4. Current amblyopia treatment (other than spectacles)

- 12 weeks of at least 2 hours of occlusion per day prescribed for the fellow eye
during the immediate pre-enrollment period.

- While on current treatment, visual acuity has not improved one line (5 letters)
or more since a non-study visit at least 6 weeks ago. Both acuity measurements
to define no improvement must have been done using the same testing method.

- Treatment with atropine at any time during this pre-enrollment period is not
allowed.

- Any treatment prior to the current patching episode with stable acuity is
acceptable.

5. Spectacle correction (if applicable) for measurement of enrollment visual acuity must
meet the following criteria and be based on a cycloplegic refraction that is no more
than 6 months old:

1. Requirements for spectacle correction:

- Spherical equivalent must be within 0.50 D of fully correcting the
anisometropia.

- Hypermetropia of 3.00D or more must be corrected.

- Hypermetropia must not be under corrected by more than 1.50 D spherical
equivalent, and reduction in plus sphere must be symmetric in the two eyes.

- Cylinder power in both eyes must be within 0.50 D of fully correcting the
astigmatism.

- Cylinder axis in both eyes is within 6 degrees of the axis in the
spectacles when cylinder power is =1.00 D.

- Myopia of amblyopic eye greater than 0.50 D by spherical equivalent must be
corrected, and the glasses must not under correct the myopia by more than
0.25 D or overcorrect it by more than 0.50 D.

2. Spectacles meeting above criteria must be worn :until visual acuity in amblyopic
eye is stable (defined as 2 consecutive visual acuity measurements by the same
testing method at least 4 weeks apart with no improvement of one line (5
letters) or more.

6. Eye examination within 6 months prior to enrollment

7. Parent available for at least one year of follow-up, has access to phone), and
willing to be contacted by clinical site and Jaeb Center staff

8. In the investigator's judgment, the subject is likely to comply with prescribed
treatment (e.g., no history of poor compliance with patching treatment) and unlikely
to continue to improve by using 2 hours of patching per day alone.

Exclusion Criteria:

1. Myopia more than -6.00 D (spherical equivalent) in either eye.

2. Current vision therapy or orthoptics

3. Ocular cause for reduced visual acuity

- nystagmus per se does not exclude the subject if the above visual acuity
criteria are met

4. Prior intraocular or refractive surgery

5. History of narrow-angle glaucoma

6. Bronchial asthma or severe pulmonary disease

7. Strabismus surgery planned within 26 weeks

8. Known allergy to levodopa or carbidopa

9. History of dystonic reactions

10. Current use of oral iron supplements including multivitamins containing iron during
treatment with levodopa-carbidopa

11. Current use of antihypertensive, anti-depressant medications, phenothiazines,
butyrophenones, risperidone and isoniazid, non-specific monoamine oxidase inhibitors,
or medication for the treatment of attention deficit hyperactivity disorder

12. Known liver disease

13. History of melanoma

14. Known psychological problems

15. Known skin reactions to patch or bandage adhesives

16. Prior levodopa treatment

17. Treatment with topical ophthalmic atropine within the past 12 weeks

18. A physician-prescribed diet high in protein

19. Females who are pregnant, lactating, or intend to become pregnant within the next 34
weeks.

- A negative urine pregnancy test will be required for all females who have
experienced menarche.

- Requirements regarding pregnancy testing prior to enrollment may be further
defined by each individual Institutional Review Board.



Age minimum: 7 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amblyopia

Intervention(s)

Drug: Levodopa/Carbidopa

Drug: Placebo

Other: Patching

Primary Outcome(s)

Amblyopic Eye Visual Acuity [Time Frame: 18 weeks after enrollment]

Secondary Outcome(s)

Adverse Event [Time Frame: 26 weeks after enrollment]

Adverse Event Requiring Drug Discontinuation [Time Frame: 26 weeks after enrollment]

Amblyopia Resolution [Time Frame: 10 weeks after enrollment]

Amblyopia Resolution [Time Frame: 16 weeks after enrollment]

Amblyopia Resolution [Time Frame: 18 weeks after enrollment]

Amblyopia Resolution [Time Frame: 26 weeks after enrollment]

Amblyopia Resolution [Time Frame: 4 weeks after enrollment]

Amblyopic Eye Visual Acuity [Time Frame: 10 weeks after enrollment]

Amblyopic Eye Visual Acuity [Time Frame: 16 weeks after enrollment]

Amblyopic Eye Visual Acuity [Time Frame: 26 weeks after enrollment]

Amblyopic Eye Visual Acuity [Time Frame: 4 weeks after enrollment]

Fellow Eye Visual Acuity [Time Frame: 18 weeks after enrollment]

Stereoacuity [Time Frame: 18 weeks after enrollment]

Study Related Adverse Event [Time Frame: 26 weeks after enrollment]

Symptom Survey Score [Time Frame: 10 weeks after enrollment]

Symptom Survey Score [Time Frame: 16 weeks after enrollment]

Symptom Survey Score [Time Frame: 18 weeks after enrollment]

Symptom Survey Score [Time Frame: 26 weeks after enrollment]

Symptom Survey Score [Time Frame: 4 weeks after enrollment]

Visual Acuity Improvement [Time Frame: 10 weeks after enrollment]

Visual Acuity Improvement [Time Frame: 16 weeks after enrollment]

Visual Acuity Improvement [Time Frame: 18 weeks after enrollment]

Visual Acuity Improvement [Time Frame: 26 weeks after enrollment]

Visual Acuity Improvement [Time Frame: 4 weeks after enrollment]

Secondary ID(s)

2U10EY011751

ATS 17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Eye Institute (NEI)