- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244996
Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Experimental: Lycium Barbarum
Daily Lycium Barbarum dosage: 10g of granules for 12 months
|
Traditional Chinese Herbs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ETDRS Visual Acuity (High Contrast)
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Field Sensitivity
Time Frame: 12 months
|
Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central 30 degree visual field at time point of baseline and 12 months. Visual field is to measure the size of the field of view and the sensitivity of the corresponding locations of the field of view. The change of sensitivity (dB) between 12-month time point and baseline 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 |
12 months
|
Amplitudes of Flash Electroretinogram
Time Frame: 12 months
|
The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation. The change of cone response b-wave amplitude (uV) between 12-month and baseline will be provided to show the effect of interventions. The b-wave amplitude is to measure the magnitude of electrical responses of cone cells in the retina. 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
|
Implicit Times of Flash Electroretinogram
Time Frame: 12 months
|
The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation. The change of cone response b-wave implicit time (ms) between 12-month and baseline will be provided to show the effect of interventions. The b-wave implicit time is to measure the physiological changes of cone cells in the retina. 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
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01121876
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinitis Pigmentosa
-
MeiraGTx UK II LtdSyne Qua Non Limited; Bionical EmasCompletedGene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)X-Linked Retinitis PigmentosaUnited Kingdom, United States
-
Oslo University HospitalRecruitingRetinitis Pigmentosa | Retinitis Pigmentosa 11Norway
-
Jinnah Burn and Reconstructive Surgery Centre,...The Layton Rahmatullah Benevolent Trust (LRBT) Free Eye Hospital, Township... and other collaboratorsRecruitingRetinitis Pigmentosa (RP)Pakistan
-
AbbVieActive, not recruitingAdvanced Retinitis PigmentosaUnited States
-
jCyte, IncCalifornia Institute for Regenerative Medicine (CIRM)CompletedRetinitis Pigmentosa (RP)United States
-
Janssen Research & Development, LLCJanssen Research & Development, LLCActive, not recruitingX-Linked Retinitis PigmentosaBelgium, Canada, United States, Israel, United Kingdom, Spain, Denmark, France, Italy, Netherlands, Switzerland
-
Janssen Research & Development, LLCActive, not recruitingX-Linked Retinitis PigmentosaUnited States, United Kingdom
-
GenSight BiologicsRecruitingNon-syndromic Retinitis PigmentosaUnited States, France, United Kingdom
-
Janssen Research & Development, LLCJanssen Research & Development, LLCActive, not recruitingX-Linked Retinitis PigmentosaUnited States, Canada, Israel, United Kingdom, Spain, Denmark, France, Belgium, Italy, Netherlands, Switzerland
-
BiogenCompletedX-Linked Retinitis PigmentosaUnited States, United Kingdom
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States