Clinical Trial: Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

Brief Summary:

Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB) treatment on retinal functions, especially the cone function, and retinal structure in patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial

Setting: Primary Care clinical trial

Participants: 120 RP subjects will be recruited from Ophthalmology department at The University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1 year. After the 1st year, both groups will stop the treatment and all subjects will also have the same eye exam in 6-month period for the 2nd year.

Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4 programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual acuity.

Results: Lycium barbarum treatment provides the immediate effect and the persistent effect on retinal functions and structure in patients with retinitis pigmentosa to improve the cone activity. It does not cause any harmful effect to the subjects.

Conclusion: Cone rescue is an alternative approach to save the vision for RP patients. The result of this study will provide valuable information for the treatment of RP. The antioxidative effect of LB is believed to delay or minimize the cone degeneration in RP and the intake of LB will be a very economic way in the RP treatment.