Dose Ranging Study of Carbidopa-levodopa
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|ClinicalTrials.gov Identifier: NCT03023059|
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : December 11, 2020
From 3 large patient databases, patients diagnosed with AMD who have never taken levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD at 79 years.
L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects the retina and downregulates VEGF, which is the cause of neovascularization.
The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD.
The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and measure the effects on visual acuity, retinal abnormalities due to "wet" AMD, and document the number of anti-VEGF injections required during the study.
|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration||Drug: Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proof of Concept and Dose Ranging Study of Carbidopa-levodopa in Neovascular AMD|
|Actual Study Start Date :||May 2, 2017|
|Actual Primary Completion Date :||March 18, 2020|
|Actual Study Completion Date :||May 4, 2020|
Experimental: Escalating dose of carbidopa-levodopa
The intervention is that patients will receive open label, commercially available Carbidopa-Levodopa 25 Mg-100 Mg oral tablet, once daily hs for one month, followed by one tablet dosed three times daily, in the morning, with supper and hs for one month, followed by two tablets dosed three times daily, in the morning, with supper and hs for one month (100-600 mg of levodopa daily). This is the equivalent of very low to moderate doses of carbidopa-levodopa in patients with Parkinson's disease (daily dose of levodopa 200-800 mg).
Drug: Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet
See Arm description
Other Name: Sinemet
- Change in ETDRS visual acuity [ Time Frame: From start of study to end (78-112 days) ]Visual acuity measured with optimum optical correction, using a standard ETDRS chart
- Change in central retinal (macular) thickness [ Time Frame: From start of study to end (78-112 days) ]Central retinal thickness measured by SD OCT
- New retinal blood (hemorrhage) [ Time Frame: From start of study to end (78-112 days) ]Visible blood on direct retinal examination
- Treatment Emergent Adverse Events [ Time Frame: From start of study to end (78-112 days) ]Vital signs, eye examinations and nondirected subjective adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023059
|United States, Arizona|
|Robert W Snyder, MD, PhD, PC|
|Tucson, Arizona, United States, 85712|
|Principal Investigator:||Robert W Snyder, MD, PhD||Robert W Snyder, MD, PhD, PC|
|Study Director:||Timothy C Fagan, MD||Robert W Snyder, MD, PhD, PC|