Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

NCT02244996 | Completed Results

• 1 other identifier: 01121876
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa; Lycium barbarum; Antioxidation; Visual field; Electroretinogram

Outcome Measures

Primary Outcomes (1)

• ETDRS Visual Acuity (High Contrast)

  The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction. The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions. The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.

  12 months

Secondary Outcomes (3)

• Visual Field Sensitivity

  12 months

• Amplitudes of Flash Electroretinogram

  12 months

• Implicit Times of Flash Electroretinogram

  12 months

Study Arms (2)

Lycium Barbarum

EXPERIMENTAL

Daily Lycium Barbarum dosage: 10g of granules for 12 months

Dietary Supplement: Lycium Barbarum

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Lycium Barbarum DIETARY_SUPPLEMENT

Traditional Chinese Herbs

Also known as: Wolfberry

Lycium Barbarum

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 30877066 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

lycium barbarum polysaccharide

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Henry Chan
• Organization: Hong Kong Polytechnic University

henryhl.chan@polyu.edu.hk

85227667937

Study Officials

• Henry HL Chan, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 19, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: November 1, 2017
• Last Updated: February 19, 2019
• Results First Posted: January 28, 2019

Record last verified: 2019-01

Locations

HK (1)