Manufacture and testing of overencapsulated tablets and placebo capsules for research purposes - LAMDARCT clinical trial

Schedule 5, (2) The public contract concerns the production of a prototype, or supply of other novel goods or services, for the purpose of (c) other research, experiment, study or development.

Age-related macular degeneration (AMD) is a leading cause of visual loss. There are two main forms of AMD: dry and wet. The current wet AMD treatment is intravitreal antiVEGF injections, repeated every 4-12 weeks. Due to the cost of the medication, the route and frequency of administration, this treatment is a significant burden on the NHS budget. An additional treatment option for wet AMD is L-dopa. L-dopa is a widely available drug (used in treatment of Parkinson's), typically in the form of Carbidopa-L-Dopa. It is taken as an oral tablet and is significantly cheaper than the antiVEGF injections.

The study will be a placebo-controlled clinical trial. Eligible patients will be randomised to receive either 100mg L-DOPA+25mg carbidopa or placebo twice a day, for 24 months, in addition to the current standard of care to determine if this is a more cost-effective and easier-to-administer treatment regime than the current standard of care.

To 'blind' this clinical trial (to reduce bias) requires the development, manufacture and testing of over encapsulated 100mg L-DOPA+25mg carbidopa tablets and development and manufacture of matching placebo capsules. The expertise required to develop and manufacture these capsules in the quantity required for this trial requires outsourcing to a manufacturer licensed by the MHRA possessing the necessary technical expertise.