A Phase 2 interventional study of Levodopa/carbidopa in Albinism and Oculocutaneous Albinism, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
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.
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.
17 studies on the registry are indexed under Albinism; 8 are open to participants now.
Browse Albinism studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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Exclusion Criteria:
Treatment drug taken orally three times daily
Drug: Levodopa/carbidopa
Visual Acuity Change
Change in visual acuity from baseline to 3 months as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP). logMar lower values equals better visual outcome.
Time frame: 3 months
Contrast Sensitivity
Ancillary testing of visual/retinal function with contrast sensitivity testing. Contrast sensitivity testing measures how well the eyes can distinguish between finer and finer light increments compared to dark. This test is a chart with different capital letters organized in horizontal lines. The contrast decreases with each line. The person will move down the chart to determine the least level of contrast they can see.
Time frame: 3 months
| Milestone | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Change in visual acuity from baseline to 3 months as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP). logMar lower values equals better visual outcome.
| logMar | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| Visual Acuity Change | .774 ± .207 |
Ancillary testing of visual/retinal function with contrast sensitivity testing. Contrast sensitivity testing measures how well the eyes can distinguish between finer and finer light increments compared to dark. This test is a chart with different capital letters organized in horizontal lines. The contrast decreases with each line. The person will move down the chart to determine the least level of contrast they can see.
| score on a scale | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| Contrast Sensitivity | 23.7 ± 21.6 |
Collected over Adverse event data was collected for each patient starting at baseline through the month 4 study follow up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levodopa/Carbidopa 4mg/kg/Day | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| <=18 years | 15 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| Female | 9 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| Race/Ethnicity — Non hispanic or latino/ white | 16 |
| Race/Ethnicity — non hispanic or latino/ asian | 3 |
| Race/Ethnicity — hispanic or latino | 1 |
| Region of Enrollment(participants) | Levodopa/Carbidopa 4mg/kg/Day |
|---|---|
| United States | 19 |
| Canada | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Levodopa · Carbidopa
University of Wisconsin, Madison →