carbidopa-levodopa 25-100 mg 2 tablets daily hs

carbidopa-levodopa 25-100 mg, 2 tablets, 3 times daily, with breakfast, with supper and hs

Placebo, 2 tablets, 3 times daily, with breakfast, with supper and hs

Age Related Macular Degeneration

carbidopa-levodopa

Robert W Snyder, MD, PhD, PC

Carbidopa-Levodopa in Dry AMD With Geographic Atrophy

Carbidopa-Levodopa in Dry Age Related Macular Degeneration With Geographic Atrophy

area of retinal geographic atrophy measured by fundus autofluorescence

Central Retinal Thickness, measured by SD-OCT

New diagnosis of neovascular macular degeneration

Snyder, Robert W., M.D., Ph.D., P.C.

Randomized, prospective, placebo controlled

All tablets will be identical in appearance. The Director of Research will be aware of treatment assignment. Patients, their Care Providers and all other study staff will be blinded to treatment.

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).

Age-related Macular Degeneration

Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet

Dose Ranging Study of Carbidopa-levodopa

Proof of Concept and Dose Ranging Study of Carbidopa-levodopa in Neovascular AMD

Visual acuity measured with optimum optical correction, using a standard ETDRS chart

Central retinal thickness measured by SD OCT

Visible blood on direct retinal examination

Vital signs, eye examinations and nondirected subjective adverse events

carbidopa-levodopa 25-100 mg tablets once daily hs for up to 32 days

carbidopa-levodopa 25-100 mg tablets 3 times daily,in the morning, with supper and hs for up to 32 days

carbidopa-levodopa 25-100 mg tablets

Carbidopa-levodopa in Neovascular AMD

Short Term Effects of Carbidopa-levodopa in Neovascular AMD

The study will be terminated after the first anti-VEGF injection, which can occur 1,2,3 or 4 weeks after the start of the wtudy

Treatment with carbidopa-levodopa 25-100 mg tablets dosed once daily at bedtime for 45 +/- 5 days followed by carbidopa-levodopa 25-100 mg tablets dosed 3 times daily for 45 +/- 5 days.

Treatment with placebo for carbidopa-levodopa 25-100 mg in identical tablets dosed once daily at bedtime for 45 +/- 5 days followed by placebo for carbidopa-levodopa 25-100 mg tablets dosed 3 times daily for 45 +/- 5 days.

carbidopa-levodopa 25-100 mg

placebo for carbidopa-levodopa 25-100 mg

A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration

Pilot Study of L-DOPA Safety and Tolerability in Patients With AMD, and Proof of Concept That L-DOPA Improves Surrogate Biomarkers in Patients With Moderate to Advanced AMD

Treatment Emergent Adverse Events (AEs) will be assessed at each visit. These will be classified as mild, moderate or severe and by body organ system. All AEs will be specifically reassessed at each subsequent visit. Serious AEs will be reported to the institutional Review Board(IRB). All AEs will be aggregated by treatment arm.

After refraction to ascertain that the participant has the optimum correction for refractive error, standard visual acuity testing will be performed with an ETDRS chart. Results will be ascertained at 45 +/-5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

Using lenses for optimum correction for refractive error, Standard visual acuity testing will be performed using an ETDRS chart under standardized low light conditions. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

Using an AdaptDX machine, using standardized intensity and duration of bright light, measurement of the time after bright light exposure required to adapt to dim light will be measured using rod intercept as the measurement. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

This will be measured using a standard questionaire evaluating ability to function in low light conditions. Results will be tabulated by all correct answers and by number of correct answers on each subscale. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

Evaluating retinal structure, including drusen and reticular pseudodrusen using a standard scanning laser device. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

geographic atrophy/tyrosine

Carbidopa-Levodopa in Dry AMD With Geographic Atrophy

Dose Ranging Study of Carbidopa-levodopa

Carbidopa-levodopa in Neovascular AMD

A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration

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