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Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

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ClinicalTrials.gov Identifier: NCT02244996
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Henry HL Chan, PhD, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Dietary Supplement: Lycium Barbarum Dietary Supplement: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
Study Start Date : November 2014
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: Lycium Barbarum
Daily Lycium Barbarum dosage: 10g of granules for 12 months
Dietary Supplement: Lycium Barbarum
Traditional Chinese Herbs
Other Name: Wolfberry

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Visual field sensitivity [ Time Frame: up to 18 months ]
    Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central visual field at time points of 0, 6, 12 and 18 months. The sensitivity (dB) will be provide to show the effects 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


Secondary Outcome Measures :
  1. Amplitudes of electroretinogram [ Time Frame: 0, 6, 12 and 18 months ]
    The retinal electrical responses from electroretinogram will be measured at the time points of 0, 6, 12 and 18 months. The amplitude (uV) 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

  2. Implicit times of electroretinogram [ Time Frame: 0, 6, 12 and 18 months ]
    The retinal electrical responses from electroretinogram will be measured at the time points of 0, 6, 12 and 18 months. The implicit time (msec) 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

  3. ETDRS Visual Acuity [ Time Frame: 0, 6, 12 and 18 months ]
    The high contrast and low contrast Visual acuity will be measured at the time points of 0, 6, 12 and 18 months. The acuity (sec of arc) 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244996


Contacts
Contact: Henry HL Chan, PhD 852-27667937 henryhl.chan@polyu.edu.hk

Locations
Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
The University of Hong Kong
Investigators
Principal Investigator: Henry HL Chan, PhD The Hong Kong Polytechnic University

Responsible Party: Henry HL Chan, PhD, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02244996     History of Changes
Other Study ID Numbers: 01121876
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Henry HL Chan, PhD, The Hong Kong Polytechnic University:
Retinitis pigmentosa
Lycium barbarum
Antioxidation
Visual field
Electroretinogram

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn