Retinitis PigmentosaNCT02244996
Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
A study testing Lycium Barbarum in people with Retinitis Pigmentosa, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Lycium Barbarum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
Read the 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).
- Conditions
- Retinitis Pigmentosa
- Being tested
- Lycium Barbarum, Placebo
- Keywords
- Retinitis pigmentosa, Lycium barbarum, Antioxidation, Visual field, Electroretinogram
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycium BarbarumDietary supplement
Also called Wolfberry
Traditional Chinese Herbs
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lycium Barbarum | Experimental | Daily Lycium Barbarum dosage: 10g of granules for 12 months Receives: Dietary Supplement: Lycium Barbarum |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Visual Field Sensitivity
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
Measured: 12 months
Amplitudes of Flash Electroretinogram
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.
Measured: 12 months
Implicit Times of Flash Electroretinogram
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Henry HL Chan, PhD, The Hong Kong Polytechnic University
- Investigators
- Henry HL Chan, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244996
- Sponsor's protocol ID
- 01121876
- Status last verified
- Jan 2019
- First submitted
- 17 Sep 2014
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30877066
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
- ClinicalTrials.gov ID
- NCT02244996
- Acronym / sponsor ID
- 01121876
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Lycium barbarum, Antioxidation, Visual field, Electroretinogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycium Barbarum | Experimental | Dietary Supplement: Lycium BarbarumDaily Lycium Barbarum dosage: 10g of granules for 12 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycium BarbarumAlso: WolfberryTraditional Chinese Herbs | Dietary supplement | Lycium Barbarum |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
Visual Field Sensitivity
Time frame: 12 months
Amplitudes of Flash Electroretinogram
Time frame: 12 months
Implicit Times of Flash Electroretinogram
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30877066Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry HL Chan, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycium Barbarum in people with Retinitis Pigmentosa, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETDRS Visual Acuity (High Contrast) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.