Vision Response to Dopamine Replacement

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-17

Study Completion Date

2018-04-12

Brief Summary

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The purpose of the study is to evaluate and document physiologic and functional changes in visual performance and retinal function of patients diagnosed with albinism (a dopamine deficiency state) following a trial of oral Levodopa/carbidopa treatment.

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Detailed Description

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In this study the investigators propose that the retina itself in albinism is deficient in dopamine, and vision improvement will occur as a result of improved retinal function in response to the deficient neurotransmitter dopamine. This study has a pretest-posttest design in order to determine if improvement in vision is in response to replacement of deficiency (dopamine). The electroretinography (ERG) testing and optical coherence tomography (OCT) will be critical determinants to confirm vision improvement as a result of improved retinal function, but are not primary outcome data. Main outcome measures will be collected at pre-treatment, 1 month, 3 months, and 4 months. Change in visual acuity as measured in logMAR by Snellen or sweep visual evoked potential (SVEP) after 3 months of treatment is the primary outcome. Patients include OCA1a patients, OCA1b, OCA2, and unclassified Oculocutaneous albinism (OCA). OCA1a patients clinically are known to have the worst vision, and physiologically have the lowest (or absent) levels of tyrosinase function (Dopamine Production). All patients will be treated with Levodopa/carbidopa 4mg/kg/day in three divided doses.

Conditions

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Albinism Oculocutaneous Albinism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levodopa/carbidopa 4mg/kg/day

Treatment drug taken orally three times daily

Group Type OTHER

Levodopa/carbidopa

Intervention Type DRUG

This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.

Interventions

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Levodopa/carbidopa

This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.

Intervention Type DRUG

Other Intervention Names

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Sinemet Atamet Parcopa

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of oculocutaneous albinism
* age over 3 and weight over 25 lbs.

Exclusion Criteria

* ocular only albinism
* ocular pathology other than albinism
* neurologic disease, history of myocardial infarction, history of clinical depression, pregnancy

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No