Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia - Full Text View

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00789672

Purpose

This pilot study is being conducted as a prelude to a randomized trial. 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, and to provide limited data on its safety. In addition, this study will address whether oral levodopa with patching improves the visual acuity of subjects with residual amblyopia and provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.

Condition	Intervention	Phase
Amblyopia	Drug: levodopa/carbidopa Device: Patching	Phase II Phase III

Drug Information available for: Levodopa Carbidopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:

Tolerability of levodopa by adverse events reported and symptom survey [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: levodopa/carbidopa Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) Device: Patching 2 hours daily patching

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.

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
- Females who are potential subjects should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
- 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789672

Contacts

Contact: Raymond T. Kraker, M.S.P.H.	813-975-8690	pedig@jaeb.org
Contact: Heidi A. Gillespie	813-975-8690	pedig@jaeb.org

Locations

United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Study Chair:

Michael X. Repka, M.D.

Wilmer Eye Institute

More Information

NEI Clinical Studies Database This link exits the ClinicalTrials.gov site

Responsible Party:	Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director )
Study ID Numbers:	NEI-141
Study First Received:	October 27, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789672
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):

Amblyopia
Patching
Levodopa

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Levodopa
Dopamine
Vision Disorders
Amblyopia

Eye Diseases
Carbidopa
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Antiparkinson Agents
Dopamine Agents
Enzyme Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009