N/A
Completed N=50
Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
Source: ClinicalTrials.gov NCT02244996 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: ETDRS Visual Acuity (High Contrast) — -0.02; 0.11 log unit
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ETDRS Visual Acuity (High Contrast) |
-0.02; 0.11 | — |
| SECONDARY Visual Field Sensitivity |
0.32; -0.16 | — |
| SECONDARY Amplitudes of Flash Electroretinogram |
2.75; -4.00 | — |
| SECONDARY Implicit Times of Flash Electroretinogram |
-1.33; -1 | — |
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT02244996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.