Diabetic Macular Edema (DME)NCT06846073
Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of DME.
A study testing The combination of intravitreal anti-VEGF and dexamethasone implants injections. in people with Diabetic Macular Edema (DME), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-VEGF superior to anti-VEGF monotherapy in the treatment of DME in Chinese patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- The combination of intravitreal anti-VEGF and dexamethasone implants injections.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1/type 2 diabetes mellitus with good glycaemic control and glycated haemoglobin ≤ 10.0%; DR stage II-III;
- DME with involvement of the central concavity and resulting in the patient's vision loss;
- Central retinal thickness (CRT) ≥250 μm;
- No refractive interval clouding and pupillary constriction affecting fundus examination;
- No Pan-Retinal Photocoagulation treatment within 3 months before enrolment;
- No macular laser treatment in the past or during the follow-up period;
- Good patient cooperation and compliance.
Who cannot join
- other macular lesions such as macular preexisting membranes, macular schisis, or other causes of macular oedema such as uveitis and central retinal vein occlusion;
- Co-existence of diabetic optic neuropathy;
- Previous intraocular injection therapy such as anti-VEGF drugs or glucocorticoid drugs in the target eye;
- History of vitreoretinal surgery in the target eye;
- A history of uncontrolled stable glaucoma or hypertension, hormonal hypertension in the target eye;
- Aphakic eyes with posterior lens capsule rupture with an anterior chamber IOL (ACIOL), iris or transscleral fixed intraocular IOLs, and patients with posterior lens capsule rupture;
- Pregnant or breastfeeding patients, uncontrolled hypertension within 3 months, cerebrovascular accident or myocardial infarction, uncontrolled diabetes mellitus, or other reasons for not being able to co-operate with the relevant examination;
- Lost visits and data loss.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Prospective Clinical Study on the Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of Diabetic Macular Edema (DME) in Naive Patients.
The goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-VEGF superior to anti-VEGF monotherapy in the treatment of DME in Chinese patients. The main questions it aims to answer are:
- Whether combination therapy improves the best corrected visual acuity at 6 months and 12 months?
- Does combination therapy improve retinal anatomy better than monotherapy at each time point?
Read more
Researchers will compare the combination therapy to the monotherapy to see if dexamethasone implant combined with anti-VEGF will leads to better results.
Participants will:
- be randomly assigned to one of two groups with equal probability to receive the combination of intravitreal anti-VEGF and dexamethasone implant injections or intravitreal anti-VEGF injections.
- During the first 3 months, patients in both groups will receive monthly injections of anti-VEGF. In the double protocol group, the first dexamethasone implant injection will be administered simultaneously with the first loading dose of anti-VEGF injections. Between 4 and 12 months, patients will receive intravitreal anti-VEGF injections as needed/pro-re-nata (PRN).
- Patients will have regular follow-up. Routine examination includes Central retinal thickness (CRT), intraocular pressure (IOP), slit lamp examination, best corrected visual acuity (BCVA) and OCT.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- The combination of intravitreal anti-VEGF and dexamethasone implants injections.
- Keywords
- dexamethasone implant, vascular endothelial growth factor, Corticosteroids, combination therapy, biomarker, best corrected visual acuity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The combination of intravitreal anti-VEGF and dexamethasone implants injections.Combination product
Early combination of intravitreal dexamethasone implant and anti-VEGF injection for the treatment of DME.
| Study group | Role | What they receive |
|---|---|---|
| The combination of intravitreal anti-VEGF and dexamethasone implants injections. | Experimental | The patients will receive the combination of intravitreal anti-VEGF and dexamethasone implants injections. Receives: Combination Product: The combination of intravitreal anti-VEGF and dexamethasone implants injections. |
| Anti-VEGF injections monotherapy | No intervention | The patients will receive intravitreal anti-VEGF injections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6.
BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart.
Measured: 6 month.
Secondary outcomes (3)
Average change in best corrected visual acuity (BCVA) of each group from baseline to month 3, 12.
BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart.
Measured: 3 month and 12 month
Average change in central retinal thickness (CRT) of each group from baseline to month 3, 6,12.
Central retinal thickness (CRT) is a measurement of the macula from the internal limiting membrane to the RPE and can be quantified by OCT scans
Measured: 3, 6 and 12 month
The proportion of eyes with a 5-letter /10-letter improvement from baseline of BCVA at month 6 and 12.
BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart.
Measured: 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start30 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Eye Hospital, Jiaxing Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Zhiqing Chen, M.D., Study chair, Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846073
- Sponsor's protocol ID
- 2024-0369
- Status last verified
- Nov 2024
- First submitted
- 5 Dec 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographic data, diagnostic results, treatment data, lab test results, follow-up data Etc.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study on the Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of Diabetic Macular Edema (DME) in Naive Patients.
- ClinicalTrials.gov ID
- NCT06846073
- Acronym / sponsor ID
- 2024-0369
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- dexamethasone implant, vascular endothelial growth factor, Corticosteroids, combination therapy, biomarker, best corrected visual acuity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Eye Hospital, Jiaxing Hospital of Traditional Chinese Medicine
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (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 goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-VEGF superior to anti-VEGF monotherapy in the treatment of DME in Chinese patients. The main questions it aims to answer are:
- Whether combination therapy improves the best corrected visual acuity at 6 months and 12 months?
- Does combination therapy improve retinal anatomy better than monotherapy at each time point?
Researchers will compare the combination therapy to the monotherapy to see if dexamethasone implant combined with anti-VEGF will leads to better results.
Participants will:
- be randomly assigned to one of two groups with equal probability to receive the combination of intravitreal anti-VEGF and dexamethasone implant injections or intravitreal anti-VEGF injections.
- During the first 3 months, patients in both groups will receive monthly injections of anti-VEGF. In the double protocol group, the first dexamethasone implant injection will be administered simultaneously with the first loading dose of anti-VEGF injections. Between 4 and 12 months, patients will receive intravitreal anti-VEGF injections as needed/pro-re-nata (PRN).
- Patients will have regular follow-up. Routine examination includes Central retinal thickness (CRT), intraocular pressure (IOP), slit lamp examination, best corrected visual acuity (BCVA) and OCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The combination of intravitreal anti-VEGF and dexamethasone implants injections. | Experimental | Combination Product: The combination of intravitreal anti-VEGF and dexamethasone implants injections.The patients will receive the combination of intravitreal anti-VEGF and dexamethasone implants injections. |
| Anti-VEGF injections monotherapy | No intervention | –The patients will receive intravitreal anti-VEGF injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 1/type 2 diabetes mellitus with good glycaemic control and glycated haemoglobin ≤ 10.0%; DR stage II-III;
- DME with involvement of the central concavity and resulting in the patient's vision loss;
- Central retinal thickness (CRT) ≥250 μm;
- No refractive interval clouding and pupillary constriction affecting fundus examination;
- No Pan-Retinal Photocoagulation treatment within 3 months before enrolment;
Key exclusion criteria (8 listed)
- other macular lesions such as macular preexisting membranes, macular schisis, or other causes of macular oedema such as uveitis and central retinal vein occlusion;
- Co-existence of diabetic optic neuropathy;
- Previous intraocular injection therapy such as anti-VEGF drugs or glucocorticoid drugs in the target eye;
- History of vitreoretinal surgery in the target eye;
- A history of uncontrolled stable glaucoma or hypertension, hormonal hypertension in the target eye;
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 |
|---|---|---|
| The combination of intravitreal anti-VEGF and dexamethasone implants injections.Early combination of intravitreal dexamethasone implant and anti-VEGF injection for the treatment of DME. | Combination product | The combination of intravitreal anti-VEGF and dexamethasone implants injections. |
Primary outcome
Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6.
Time frame: 6 month.
BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart.
3 secondary outcomes
Average change in best corrected visual acuity (BCVA) of each group from baseline to month 3, 12.
Time frame: 3 month and 12 month
Average change in central retinal thickness (CRT) of each group from baseline to month 3, 6,12.
Time frame: 3, 6 and 12 month
The proportion of eyes with a 5-letter /10-letter improvement from baseline of BCVA at month 6 and 12.
Time frame: 6 month and 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes. demographic data, diagnostic results, treatment data, lab test results, follow-up data Etc.
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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.
Zhiqing Chen, M.D. study chair
Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The combination of intravitreal anti-VEGF and dexamethasone implants injections. in people with Diabetic Macular Edema (DME), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6. (time frame: 6 month.). 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 25 Feb 2025.