An Innovative Chinese Herbal Formula for Macular Edema

NCT05122702 | Unknown Phase 2 DMC

• 1 other identifier: Macular Edema study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Macula Edema

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (6)

• The change of Best-Corrected Visual Acuity (BCVA) score at week 16

  16 weeks

• The change of Central retinal (macular) thickness (CMT) at week 16

  16 weeks

• The change of Optical coherence tomography angiography (OCTA) at week 12 & 16

  12 & 16 weeks

• The change of Five-Level Version of EuroQoL-five dimensions questionnaire (EQ-5D-5L) at week 12 & 16

  12 & 16 weeks

• The change of National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) at week 12 & 16

  12 & 16 weeks

Study Arms (2)

Active Arm

EXPERIMENTAL

18.75g of "Modified Shenling Baizhu San" granules will be taken twice daily for 12 weeks.

Drug: modified Shenling Baizhu San

Placebo Arm

PLACEBO COMPARATOR

18.75g of placebo granules will be taken twice daily for 12 weeks.

Other: Placebo

Interventions

modified Shenling Baizhu San DRUG

modified Shenling Baizhu San granules, twice daily for 12 weeks.

Active Arm

Placebo OTHER

Placebo granules, twice daily for 12 weeks.

Also known as: Placebo granules

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Study Officials

• Zhixiu Lin, PhD

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiahe Song, PhD

CONTACT

28733252; thsong@cuhk.edu.hk

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: November 17, 2021
• Study Start: July 12, 2022
• Primary Completion: July 31, 2024
• Study Completion: January 1, 2025
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)