Clinical trial NCT02244996: Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
Official title: Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: Retinitis pigmentosa
Lycium barbarum
Antioxidation
Visual field
Electroretinogram
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2014-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study was a randomized controlled trial with a double-masked, placebo-controlled design. All the subjects were randomly allocated into either LB (treatment) group or placebo (control) group.

All the eligible subjects had the eye examination, including VA using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, refractions, tonometry, external and internal ocular health assessments, and fundus photo-documentation. Three additional tests were conducted to investigate the functional and structural changes in the RP patients, including Ganzfeld Electroretinogram, Humphrey Visual Field Analyser (Zeiss, Dublin, USA) and Spectral-domain Optical Coherent Tomography (SD-OCT) (Heidelberg Engineering, USA).

Eligibility criteria: Inclusion Criteria:

Ocular conditions:

* Retinitis pigmentosa;
* best corrected VA LogMAR 0.20 or better;
* Humphrey Visual Field Analysis (HVFA) 30-2 total mean defect \> or = 250 Decibel;
* Intra-ocular pressure (IOP) \<21 mmHg;
* van Herrick ratio \< or = 0.5;
* no other ocular diseases

Dietary conditions:

* Fruit and vegetable intake \<10 servings/day;
* spinach or kale intake \< or = serving/day;
* dietary lutein intake \< or = 5.4mg/day;
* no intake of cod liver oil or omega-3 capsules;
* dietary Lycium barbarum intake \< or =10 fruits/week;
* supplement intake \< or = 5000 IU/day of Vit. A and \< or = 30 IU/day of Vit. E;
* alcoholic consumption \< or = 3 beverages/day

Exclusion Criteria:

* BMI \> 40;
* intake of any anticoagulants (especially Warfarin),
* pregnant or planning to be pregnant;
* smoking;
* other clinically significant systemic diseases, eg. diabetes, liver disease and heart disease

Primary outcomes:
measure: ETDRS Visual Acuity (High Contrast)
timeFrame: 12 months
Secondary outcomes:
measure: Visual Field Sensitivity
timeFrame: 12 months
measure: Amplitudes of Flash Electroretinogram
timeFrame: 12 months
measure: Implicit Times of Flash Electroretinogram
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Henry HL Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan HH, Lam HI, Choi KY, Li SZ, Lakshmanan Y, Yu WY, Chang RC, Lai JS, So KF. Delay of cone degeneration in retinitis pigmentosa using a 12-month treatment with Lycium barbarum supplement. J Ethnopharmacol. 2019 May 23;236:336-344. doi: 10.1016/j.jep.2019.03.023. Epub 2019 Mar 12.