NCT03197493

Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD)

Extension of Protocol 002, Carbidopa-levodopa in Neovascular Extension of Protocol 002, Carbidopa-levodopa in Neovascular AMD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Snyder, Robert W., M.D., Ph.D., P.C. · Individual
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will use the two higher dose regimens of protocol 0002. these will be assigned according to how well the higher dose was tolerated in protocol 0002.

Detailed description

This extension will employ the same medications, measurements, guidelines for anti-VEGF injections and safeguards as in protocol 0002. In combination with protocol 0002, it will provide a total of 12 months of therapy with carbidopa-levodopa.

Conditions

• Macula; Degeneration
• Retina

Interventions

Type	Name	Description
DRUG	carbidopa-levodopa 25-100 mg	High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-07-09
• Completion: 2020-07-09
• First posted: 2017-06-23
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study