Macula EdemaPhase 2NCT05122702
An Innovative Chinese Herbal Formula for Macular Edema
A Phase 2 study testing modified Shenling Baizhu San in people with Macula Edema, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Macular edema (ME) is caused by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium induced by outer/inner blood-retinal barrier dysfunction (BRB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macula Edema
- What is being tested?
- modified Shenling Baizhu San
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Jul 2022to 27 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both gender;
- Age from 18 to 80 years;
- Known diagnosed with ME;
- Agree to under optical examination and willing to complete questionnaires and take medications as scheduled; and
- Agree to participate in the study and provide written informed consent. (for those illiterate subjects, their family member can sign the consent form upon subject's agreement)
Who cannot join
- Known ocular media opacities, such as cataract, vitreous hemorrhage, asteroid hyalosis, that affect the determination of retinal thickness from OCT imaging;
- Known clinically significant macular edema (CSME). The definition of CSME: if one or more of the following criteria are met 1) retinal thickening at or within 500 μm of the center of the macula; 2) hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; 3) a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula;
- On concomitant oral or injectable corticosteroids, topical non-steroidal anti-inflammatory drugs (NSAID) eye drops, leukotriene inhibitors, anti-VEGF, immunosuppressants for the treatment of ME within past 6 months or other Chinese herbal medicine for the treatment of ME within past month;
- Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
- Documented pregnant or lactating; or
- Subjects participating in other clinical studies at the same time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of an Innovative Chinese Herbal Formula for the Treatment of Macular Edema: A Double-blind, Randomized, Placebo-Controlled Trial
Macular edema (ME) is caused by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium induced by outer/inner blood-retinal barrier dysfunction (BRB). It is most commonly seen following many diseases such as diabetes mellitus (DM), intraocular surgery, uveitis, retinal vein occlusion, and posterior segment inflammatory disease. An estimated 11% of patients with DM develop diabetic macular edema (DME). While the overall prevalence of DME among patients with DM aged 20 to 79 years is approximately 7.5%, the risk increases over time. Currently, there is no cure for ME.
Chinese medicine (CM) is widely used to manage ME in China and other East Asian countries. Among them, Shenling Baizhu San (SBS) is one of the most commonly used formulae. In this proposal, a randomized, double-blind, placebo-controlled, multicenter clinical trial will be undertaken to evaluate the efficacy and safety of modified SBS (mSBS) developed by the project team for the treatment of ME.
Eligible subjects will be recruited and assigned randomly to receive orally mSBS or placebo twice a day for 12 consecutive weeks, with follow-up for another 4 weeks after stopping the treatment to observe the duration of efficacy.
Read the detailed description
Macular edema (ME) is characterized by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium, and the condition can be induced by outer/inner blood-retinal barrier dysfunction (BRB). It is most commonly seen following a number of local and systemic diseases and procedures such as diabetes, intraocular surgery, uveitis, retinal vein occlusion, posterior segment inflammatory disease, and cataract surgery. Pathologically, ME is characterized by a retinal thickening in the macular area due to the breakdown of the BRB. ME patients often suffer from blurred vision, dark spots, and deformation, which can seriously affect their central vision, and in severe case, can lead to blindness.
Nowadays, ME treatment options include intravitreal anti-vascular endothelial growth factor (VEGF) agents, intravitreal long-acting steroid, non-steroidal anti-inflammatory drugs, corticosteroids, carbonic anhydrase inhibitors, and subthreshold macular laser. Although the above treatment options have made great progress, the possible side effects of the potentially toxic pharmaceutical agents should be always alert by clinician. A stepwise therapeutic approach is a challenge for the management of ME arises in the chronic and persistent case. Additionally, surgical management should be considered for unremitting cases of ME. Side effects such as scotomas, corresponding to the laser burns, have been frequently noticed by the patients following photocoagulation.
Currently, there is no cure for ME in conventional medicine. Chinese medicine (CM) is becoming popular for managing ME in China and other East Asian countries. Several research groups worldwide have previously conducted clinical studies to evaluate the effectiveness of Chinese herbal medicines for the treatment of ME in recent decades. This study is of an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of macular edema. The goal of this treatment modality is to reduce the accumulation of intraretinal fluid, thus leading to improved visual acuity. Among different Chinese herbal formulae for ME, Shenling Baizhu San (SBS), which was originally described "Formulas from the Imperial Pharmacy" (Taiping Huiming Hejiju Fang in Chinese), has been reported have good efficacy in the treatment.
This study will use an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of ME. This clinical study will be able to provide robust clinical evidence on the efficacy and safety of mSBS for ME. Subjects will be recruited and assigned to receive orally mSBS or placebo twice a day for 12 weeks, with follow-up for another 4 weeks after stopping the treatment to observe the duration of efficacy.
- Conditions
- Macula Edema
- Being tested
- modified Shenling Baizhu San, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Shenling Baizhu SanDrug
modified Shenling Baizhu San granules, twice daily for 12 weeks.
PlaceboOther
Also called Placebo granules
Placebo granules, twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | 18.75g of "Modified Shenling Baizhu San" granules will be taken twice daily for 12 weeks. Receives: Drug: modified Shenling Baizhu San |
| Placebo Arm | Placebo comparator | 18.75g of placebo granules will be taken twice daily for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Central retinal (macular) thickness (CMT) score at week 12
A standard nine-subfield Early Treatment of Diabetic Retinopathy Study grid will represent the averaged CMT and total macular volume. The highest score of CMT, the more severe of edema.
Measured: 12 weeks
The change of Nest-Corrected Visual Acuity (BCVA) score at week 12
For BCVA, Each letter of the acuity chart will score a value of 0.02 log unit. The highest score of central retinal (macular) thickness (CMT), the poorer of visual acuity.
Measured: 12 weeks
Secondary outcomes (6)
The change of Best-Corrected Visual Acuity (BCVA) score at week 16
For BCVA, Each letter of the acuity chart will score a value of 0.02 log unit. The highest score of central retinal (macular) thickness (CMT), the poorer of visual acuity.
Measured: 16 weeks
The change of Central retinal (macular) thickness (CMT) at week 16
A standard nine-subfield Early Treatment of Diabetic Retinopathy Study grid will represent the averaged CMT and total macular volume. The highest score of CMT, the more severe of edema.
Measured: 16 weeks
The change of Optical coherence tomography angiography (OCTA) at week 12 & 16
OCTA will measured in both eyes of all participants. The highest score, the more severe of the angiography.
Measured: 12 & 16 weeks
The change of Five-Level Version of EuroQoL-five dimensions questionnaire (EQ-5D-5L) at week 12 & 16
It is a versatile quality of life (QOL) instrument with five dimensions used to calculate quality-adjusted life years.
Measured: 12 & 16 weeks
The change of National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) at week 12 & 16
It is a vision-specific measure of HRQoL composed of eight multi-item scales, four single-item scales, and one composite score ranging in value from 0 (poor) to 100 (high HRQoL).
Measured: 12 & 16 weeks
Adverse event
Any adverse event related to study treatment will be analyzed throughout the study
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start12 Jul 2022
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Why it stopped: Can't recruit the eligible subject for years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula EdemaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, PhD, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122702
- Sponsor's protocol ID
- Macular Edema study
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of an Innovative Chinese Herbal Formula for the Treatment of Macular Edema: A Double-blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05122702
- Acronym / sponsor ID
- Macular Edema study
- Conditions
- Macula Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Can't recruit the eligible subject for years
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Macular edema (ME) is caused by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium induced by outer/inner blood-retinal barrier dysfunction (BRB). It is most commonly seen following many diseases such as diabetes mellitus (DM), intraocular surgery, uveitis, retinal vein occlusion, and posterior segment inflammatory disease. An estimated 11% of patients with DM develop diabetic macular edema (DME). While the overall prevalence of DME among patients with DM aged 20 to 79 years is approximately 7.5%, the risk increases over time. Currently, there is no cure for ME.
Chinese medicine (CM) is widely used to manage ME in China and other East Asian countries. Among them, Shenling Baizhu San (SBS) is one of the most commonly used formulae. In this proposal, a randomized, double-blind, placebo-controlled, multicenter clinical trial will be undertaken to evaluate the efficacy and safety of modified SBS (mSBS) developed by the project team for the treatment of ME.
Eligible subjects will be recruited and assigned randomly to receive orally mSBS or placebo twice a day for 12 consecutive weeks, with follow-up for another 4 weeks after stopping the treatment to observe the duration of efficacy.
Detailed description
Macular edema (ME) is characterized by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium, and the condition can be induced by outer/inner blood-retinal barrier dysfunction (BRB). It is most commonly seen following a number of local and systemic diseases and procedures such as diabetes, intraocular surgery, uveitis, retinal vein occlusion, posterior segment inflammatory disease, and cataract surgery. Pathologically, ME is characterized by a retinal thickening in the macular area due to the breakdown of the BRB. ME patients often suffer from blurred vision, dark spots, and deformation, which can seriously affect their central vision, and in severe case, can lead to blindness.
Nowadays, ME treatment options include intravitreal anti-vascular endothelial growth factor (VEGF) agents, intravitreal long-acting steroid, non-steroidal anti-inflammatory drugs, corticosteroids, carbonic anhydrase inhibitors, and subthreshold macular laser. Although the above treatment options have made great progress, the possible side effects of the potentially toxic pharmaceutical agents should be always alert by clinician. A stepwise therapeutic approach is a challenge for the management of ME arises in the chronic and persistent case. Additionally, surgical management should be considered for unremitting cases of ME. Side effects such as scotomas, corresponding to the laser burns, have been frequently noticed by the patients following photocoagulation.
Currently, there is no cure for ME in conventional medicine. Chinese medicine (CM) is becoming popular for managing ME in China and other East Asian countries. Several research groups worldwide have previously conducted clinical studies to evaluate the effectiveness of Chinese herbal medicines for the treatment of ME in recent decades. This study is of an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of macular edema. The goal of this treatment modality is to reduce the accumulation of intraretinal fluid, thus leading to improved visual acuity. Among different Chinese herbal formulae for ME, Shenling Baizhu San (SBS), which was originally described "Formulas from the Imperial Pharmacy" (Taiping Huiming Hejiju Fang in Chinese), has been reported have good efficacy in the treatment.
This study will use an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of ME. This clinical study will be able to provide robust clinical evidence on the efficacy and safety of mSBS for ME. Subjects will be recruited and assigned to receive orally mSBS or placebo twice a day for 12 weeks, with follow-up for another 4 weeks after stopping the treatment to observe the duration of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: modified Shenling Baizhu San18.75g of "Modified Shenling Baizhu San" granules will be taken twice daily for 12 weeks. |
| Placebo Arm | Placebo comparator | Other: Placebo18.75g of placebo granules will be taken twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both gender;
- Age from 18 to 80 years;
- Known diagnosed with ME;
- Agree to under optical examination and willing to complete questionnaires and take medications as scheduled; and
- Agree to participate in the study and provide written informed consent. (for those illiterate subjects, their family member can sign the consent form upon subject's agreement)
Key exclusion criteria (6 listed)
- Known ocular media opacities, such as cataract, vitreous hemorrhage, asteroid hyalosis, that affect the determination of retinal thickness from OCT imaging;
- Known clinically significant macular edema (CSME). The definition of CSME: if one or more of the following criteria are met 1) retinal thickening at or within 500 μm of the center of the macula; 2) hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; 3) a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula;
- On concomitant oral or injectable corticosteroids, topical non-steroidal anti-inflammatory drugs (NSAID) eye drops, leukotriene inhibitors, anti-VEGF, immunosuppressants for the treatment of ME within past 6 months or other Chinese herbal medicine for the treatment of ME within past month;
- Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
- Documented pregnant or lactating; or
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 |
|---|---|---|
| modified Shenling Baizhu Sanmodified Shenling Baizhu San granules, twice daily for 12 weeks. | Drug | Active Arm |
| PlaceboAlso: Placebo granulesPlacebo granules, twice daily for 12 weeks. | Other | Placebo Arm |
Primary outcome
The change of Central retinal (macular) thickness (CMT) score at week 12
Time frame: 12 weeks
A standard nine-subfield Early Treatment of Diabetic Retinopathy Study grid will represent the averaged CMT and total macular volume. The highest score of CMT, the more severe of edema.
The change of Nest-Corrected Visual Acuity (BCVA) score at week 12
Time frame: 12 weeks
For BCVA, Each letter of the acuity chart will score a value of 0.02 log unit. The highest score of central retinal (macular) thickness (CMT), the poorer of visual acuity.
6 secondary outcomes
The change of Best-Corrected Visual Acuity (BCVA) score at week 16
Time frame: 16 weeks
The change of Central retinal (macular) thickness (CMT) at week 16
Time frame: 16 weeks
The change of Optical coherence tomography angiography (OCTA) at week 12 & 16
Time frame: 12 & 16 weeks
The change of Five-Level Version of EuroQoL-five dimensions questionnaire (EQ-5D-5L) at week 12 & 16
Time frame: 12 & 16 weeks
The change of National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) at week 12 & 16
Time frame: 12 & 16 weeks
Adverse event
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Can't recruit the eligible subject for years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Zhixiu Lin, PhD principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing modified Shenling Baizhu San in people with Macula Edema, run by Chinese University of Hong Kong 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Jul 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Can't recruit the eligible subject for years). Results are not available in the source record.
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?
The change of Central retinal (macular) thickness (CMT) score at week 12 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.