Macular Cystoid EdemaPhase 4JQMMT+RANCT06234514
Manage Macular Cystoid Edema With Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab
A Phase 4 study testing Jueling Mingmu decoction and intravitreal injections of 0.5mg ranibizumab in people with Macular Cystoid Edema, run by Dongyang People's Hospital at 1 site in China.
Trial summary
The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Cystoid Edema
- What is being tested?
- Jueling Mingmu decoction and intravitreal injections of 0.5mg ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 May 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Foveal center-involved macular edema (ME) lasting less than 9 months
- Central Macular Thickness (CMT) greater than or equal to 250 μm
- Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye
- Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections
Who cannot join
- Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula
- Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases
- Concerns or doubts regarding treatment
- Known allergies to the ingredients of the medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional Chinese Medicine and Ranibizumab in the Treatment of Macular Cystoid Edema Associated With Retinal Vein Obstruction.
The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.
Read the detailed description
Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.
- Conditions
- Macular Cystoid Edema
- Being tested
- Jueling Mingmu decoction, intravitreal injections of 0.5mg ranibizumab
- Keywords
- Traditional Chinese Medicine, Ranibizumab, Retinal Vein Obstruction
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jueling Mingmu decoctionDrug
Jueling Mingmu decoction comprises stone cassia, grass cassia, Leonurus, chrysanthemum, red peony, Schizonepeta, poria, plantago, salvia miltiorrhiza, rice bud, licorice. It is designed to clear liver heat, promote diuresis, activate blood circulation, strengthen the stomach, and harmonize spleen functions.
intravitreal injections of 0.5mg ranibizumabDrug
Also called 0.5mg ranibizumab
Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Experimental | During the initial month, the patient consumed Jueling Mingmu decoction daily for one month.
Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria. Receives: Drug: Jueling Mingmu decoction; Drug: intravitreal injections of 0.5mg ranibizumab |
| Intravitreal Ranibizumab Group | Active comparator | Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria. Receives: Drug: intravitreal injections of 0.5mg ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of injections
We will calculate the mean number of intravitreal ranibizumab injections at week 48.
Measured: 48 weeks
Secondary outcomes (2)
Change in BCVA
We will assess the participants' best-corrected distance visual acuity by ETDRS charts before and after the treatment at weeks 48.
Measured: 48 weeks
The mean change of central retinal thickness (CRT).
The participants' eyes will be fully dilated; the examiner will take the macular fovea as the center and perform a multi-directional, 6 mm-long, radial linear scan of the most prominent macular lesions and take linear scans in the same direction after the treatment. CRT is defined as the distance between internal limiting membrane and external limiting membrane, excluding the fluid under the retinal pigment epithelium (RPE).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Cystoid EdemaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongyang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Hangshuai, Dongyang People's Hospital
- Investigators
- Guangjin Zhao, Study director, Dongyang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234514
- Sponsor's protocol ID
- JQMMT
- Acronym
- JQMMT+RA
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2024
- Last updated
- 22 Aug 2025
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine and Ranibizumab in the Treatment of Macular Cystoid Edema Associated With Retinal Vein Obstruction.
- ClinicalTrials.gov ID
- NCT06234514
- Acronym / sponsor ID
- JQMMT+RA / JQMMT
- Conditions
- Macular Cystoid Edema
- Keywords
- Traditional Chinese Medicine, Ranibizumab, Retinal Vein Obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Dongyang People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 31 Jan 2024 (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.
The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.
Detailed description
Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Drug: Jueling Mingmu decoction, Drug: intravitreal injections of 0.5mg ranibizumabDuring the initial month, the patient consumed Jueling Mingmu decoction daily for one month. Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria. |
| Intravitreal Ranibizumab Group | Active comparator | Drug: intravitreal injections of 0.5mg ranibizumabPatients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Foveal center-involved macular edema (ME) lasting less than 9 months
- Central Macular Thickness (CMT) greater than or equal to 250 μm
- Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye
- Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections
Key exclusion criteria (4 listed)
- Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula
- Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases
- Concerns or doubts regarding treatment
- Known allergies to the ingredients of the medication.
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 |
|---|---|---|
| Jueling Mingmu decoctionJueling Mingmu decoction comprises stone cassia, grass cassia, Leonurus, chrysanthemum, red peony, Schizonepeta, poria, plantago, salvia miltiorrhiza, rice bud, licorice. It is designed to clear liver heat, promote diuresis, activate blood circulation, strengthen the stomach, and harmonize spleen functions. | Drug | Combination Therapy Group |
| intravitreal injections of 0.5mg ranibizumabAlso: 0.5mg ranibizumabPatients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria. | Drug | Combination Therapy Group, Intravitreal Ranibizumab Group |
Primary outcome
Mean number of injections
Time frame: 48 weeks
We will calculate the mean number of intravitreal ranibizumab injections at week 48.
2 secondary outcomes
Change in BCVA
Time frame: 48 weeks
The mean change of central retinal thickness (CRT).
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
Guangjin Zhao study director
Dongyang People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jueling Mingmu decoction and intravitreal injections of 0.5mg ranibizumab in people with Macular Cystoid Edema, run by Dongyang People's Hospital at 1 site in China.
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 4 inclusion and 4 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 22 Aug 2025. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean number of injections (time frame: 48 weeks). 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 22 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.