Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

NCT ID: NCT00789672

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-12-31

Brief 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.

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.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

patching

Intervention Type: DEVICE

2 hours daily patching

levodopa/carbidopa

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

levodopa/carbidopa

Intervention Type: DRUG

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

patching

Intervention Type: DEVICE

2 hours daily patching

Interventions

levodopa/carbidopa

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

Intervention Type: DRUG

patching

2 hours daily patching

Intervention Type: DEVICE

levodopa/carbidopa

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

Intervention Type: DRUG

Other Intervention Names

Coverlet, 3M Opticlude, Ortopad®

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Ray Kraker

Director, PEDIG Coordinating Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael X. Repka, M.D.

Role: STUDY_CHAIR

Wilmer Eye Institute

Locations

Wilmer Eye Institute

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20837811 (View on PubMed)

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NEI-141

Identifier Type: -

Identifier Source: org_study_id