Trial Outcomes & Findings for Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum (NCT NCT02244996)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

12 months

Results posted on

2019-02-19

Participant Flow

Recruited from a retinal disease patient association, Retina Hong Kong, and the Optometry Clinic at The Hong Kong Polytechnic University

All the eligible subjects had the eye examination, including VA (ETDRS) charts, refractions, tonometry, external and internal ocular health assessments, fundus photo-documentation, Ganzfeld Electroretinogram, Humphrey Visual Field Analyser and Spectral-domain Optical Coherent Tomography

Participant milestones

Participant milestones
Measure	Lycium Barbarum Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs	Placebo Placebo Placebo: Placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	23	19
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Lycium Barbarum Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs	Placebo Placebo Placebo: Placebo
Overall Study Lack of Efficacy	2	6

Baseline Characteristics

Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lycium Barbarum n=23 Participants Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs	Placebo n=19 Participants Placebo Placebo: Placebo	Total n=42 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 12.2 • n=93 Participants	48.4 years STANDARD_DEVIATION 9.3 • n=4 Participants	49.4 years STANDARD_DEVIATION 10.9 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment Hong Kong	23 participants n=93 Participants	19 participants n=4 Participants	42 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo Placebo: Placebo	Lycium Barbarum n=23 Participants Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs
ETDRS Visual Acuity (High Contrast)	0.11 log unit Standard Deviation 0.17	-0.02 log unit Standard Deviation 0.09

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo Placebo: Placebo	Lycium Barbarum n=23 Participants Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs
Visual Field Sensitivity	-0.16 dB Standard Deviation 0.94	0.32 dB Standard Deviation 2.93

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo Placebo: Placebo	Lycium Barbarum n=23 Participants Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs
Amplitudes of Flash Electroretinogram	-4.00 uV Standard Deviation 7.38	2.75 uV Standard Deviation 9.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo Placebo: Placebo	Lycium Barbarum n=23 Participants Daily Lycium Barbarum dosage: 10g of granules for 12 months Lycium Barbarum: Traditional Chinese Herbs
Implicit Times of Flash Electroretinogram	-1 msec Standard Deviation 6.69	-1.33 msec Standard Deviation 5.03

Adverse Events

Lycium Barbarum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Henry Chan

Hong Kong Polytechnic University

Phone: 85227667937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place