Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborator: National Eye Institute (NEI)
• Treatments: Carbidopa; Levodopa

Criteria

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.