Diabetic RetinopathyPhase 3NCT05138029
Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
A Phase 3 study testing Ranibizumab Injection [Lucentis], Inner limiting membrane stripping and Dexamethasone intravitreal implant in people with Diabetic Retinopathy, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Select Proliferative Proliferative diabetic retinopathy(PDR) patients who are planning to undergo vitrectomy for informed notification. After obtaining informed consent, vitrectomy will be performed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Ranibizumab Injection [Lucentis], Inner limiting membrane stripping and Dexamethasone intravitreal implant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2021to May 2024
- Phase
- Phase 3
- 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
- PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy
- Type 2 diabetes, aged 18~80 years old
- Good blood sugar control (glycated hemoglobin <8.3%)
- Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial
Who cannot join
- Exclude severe infections of conjunctiva, cornea, and sclera
- Combined with other retinal vascular diseases such as retinal vein occlusion
- Cardiorenal insufficiency
- Myocardial infarction or stroke occurred within 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Rongrong Zhu, Master, 13809089545, zrreye@126.com
Jian Zhu, Bachelor, 18860975286, 1321094354@qq.com
About this study
Official title: Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
Select Proliferative Proliferative diabetic retinopathy(PDR) patients who are planning to undergo vitrectomy for informed notification. After obtaining informed consent, vitrectomy will be performed. After hemorrhage is removed, the macular shape can be obtained through intraoperative optical coherence tomography (iOCT) real-time scanning. If the central Macular Thickness (CMT) of the patient is ≥250μm, random Enter the Anti-vascular endothelial growth factor (anti-VEGF) treatment group, the internal limiting membrane stripping group and the glucocorticoid treatment group for treatment, and compare the patients' visual acuity (1 day, 7 days, 1 month, 3 months, 6 months) and The thickness of the center of the macula, compare and observe its treatment effect.
Read the detailed description
- Test method:
- Include suitable cases of diabetic retinopathy and macular edema Inclusion criteria: a. PDR patients with severe vitreous hemorrhage who cannot collect oct images and require vitrectomy b. Type 2 diabetes, aged 18~80 years old c. Good blood sugar control (glycated hemoglobin <8.3%) d. Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial Exclusion criteria: a. Exclude severe infections of conjunctiva, cornea, and sclera b. Combined with other retinal vascular diseases such as retinal vein occlusion c. Cardiorenal insufficiency d. Myocardial infarction or stroke occurred within 6 months ②Intraoperative real-time operation All patients underwent 25Gauge(25G) transplanter three-channel vitrectomy to remove cloudy vitreous or vitreous hemorrhage and posterior vitreous cortex. Through intraoperative oct, the macular area was observed in real time and the central macular thickness was measured. If central macular thickness (CMT) ≥ 250 μm, anti-VEGF, glucocorticoid, or internal limiting membrane peeling was randomly selected to treat macular edema.
- Re-examine the effect of surgery after operation The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
- Conditions
- Diabetic Retinopathy
- Being tested
- Ranibizumab Injection [Lucentis], Inner limiting membrane stripping, Dexamethasone intravitreal implant
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab Injection [Lucentis]Drug
Also called Lucentis
The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Inner limiting membrane strippingProcedure or surgery
The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Dexamethasone intravitreal implantDrug
Also called Dexamethasone Implants
The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
| Study group | Role | What they receive |
|---|---|---|
| Anti-VEGF treatment group | Experimental | Visual acuity and center thickness of the macula Receives: Drug: Ranibizumab Injection [Lucentis] |
| Inner limiting membrane stripping group | Experimental | Visual acuity and center thickness of the macula Receives: Procedure: Inner limiting membrane stripping |
| Glucocorticoid treatment group | Experimental | Visual acuity and center thickness of the macula Receives: Drug: Dexamethasone intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Review the patient's vision before surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Measured: The day before the patient's surgery
Secondary outcomes (5)
Review the patient's vision for one day after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Measured: The patient's first day after surgery
Review the patient's vision for 7 days after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Measured: 1st week after surgery
Review the patient's vision for 1 month after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Measured: 4th week after surgery
Review the patient's vision for 3 months after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Measured: 12th week after surgery
Review the patient's vision for 6 months after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Measured: 24th week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start15 Nov 2021
- Primary completionDec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rongrong Zhu, master, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138029
- Sponsor's protocol ID
- MSZ20180
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu J, Liu J, Chen YX, Yang XW, Zhu RR. COMPARE COMBINED USE OF ANTI-VEGF DRUGS DURING OR AFTER PARS PLANA VITRECTOMY FOR DIABETIC MACULAR EDEMA GUIDED BY MICROSCOPE-INTEGRATED OPTICAL COHERENCE TOMOGRAPHY. Retina. 2026 Jun 1;46(6):1046-1056. doi: 10.1097/IAE.0000000000004801.
PubMed 41687084
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
- ClinicalTrials.gov ID
- NCT05138029
- Acronym / sponsor ID
- MSZ20180
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 30 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.
Select Proliferative Proliferative diabetic retinopathy(PDR) patients who are planning to undergo vitrectomy for informed notification. After obtaining informed consent, vitrectomy will be performed. After hemorrhage is removed, the macular shape can be obtained through intraoperative optical coherence tomography (iOCT) real-time scanning. If the central Macular Thickness (CMT) of the patient is ≥250μm, random Enter the Anti-vascular endothelial growth factor (anti-VEGF) treatment group, the internal limiting membrane stripping group and the glucocorticoid treatment group for treatment, and compare the patients' visual acuity (1 day, 7 days, 1 month, 3 months, 6 months) and The thickness of the center of the macula, compare and observe its treatment effect.
Detailed description
- Test method:
- Include suitable cases of diabetic retinopathy and macular edema Inclusion criteria: a. PDR patients with severe vitreous hemorrhage who cannot collect oct images and require vitrectomy b. Type 2 diabetes, aged 18~80 years old c. Good blood sugar control (glycated hemoglobin <8.3%) d. Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial Exclusion criteria: a. Exclude severe infections of conjunctiva, cornea, and sclera b. Combined with other retinal vascular diseases such as retinal vein occlusion c. Cardiorenal insufficiency d. Myocardial infarction or stroke occurred within 6 months ②Intraoperative real-time operation All patients underwent 25Gauge(25G) transplanter three-channel vitrectomy to remove cloudy vitreous or vitreous hemorrhage and posterior vitreous cortex. Through intraoperative oct, the macular area was observed in real time and the central macular thickness was measured. If central macular thickness (CMT) ≥ 250 μm, anti-VEGF, glucocorticoid, or internal limiting membrane peeling was randomly selected to treat macular edema.
- Re-examine the effect of surgery after operation The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-VEGF treatment group | Experimental | Drug: Ranibizumab Injection [Lucentis]Visual acuity and center thickness of the macula |
| Inner limiting membrane stripping group | Experimental | Procedure: Inner limiting membrane strippingVisual acuity and center thickness of the macula |
| Glucocorticoid treatment group | Experimental | Drug: Dexamethasone intravitreal implantVisual acuity and center thickness of the macula |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy
- Type 2 diabetes, aged 18~80 years old
- Good blood sugar control (glycated hemoglobin <8.3%)
- Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial
Key exclusion criteria (4 listed)
- Exclude severe infections of conjunctiva, cornea, and sclera
- Combined with other retinal vascular diseases such as retinal vein occlusion
- Cardiorenal insufficiency
- Myocardial infarction or stroke occurred within 6 months.
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 |
|---|---|---|
| Ranibizumab Injection [Lucentis]Also: LucentisThe visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure. | Drug | Anti-VEGF treatment group |
| Inner limiting membrane strippingThe visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure. | Procedure or surgery | Inner limiting membrane stripping group |
| Dexamethasone intravitreal implantAlso: Dexamethasone ImplantsThe visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure. | Drug | Glucocorticoid treatment group |
Primary outcome
Review the patient's vision before surgery
Time frame: The day before the patient's surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
5 secondary outcomes
Review the patient's vision for one day after surgery
Time frame: The patient's first day after surgery
Review the patient's vision for 7 days after surgery
Time frame: 1st week after surgery
Review the patient's vision for 1 month after surgery
Time frame: 4th week after surgery
Review the patient's vision for 3 months after surgery
Time frame: 12th week after surgery
Review the patient's vision for 6 months after surgery
Time frame: 24th week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 41687084Zhu J, Liu J, Chen YX, Yang XW, Zhu RR. COMPARE COMBINED USE OF ANTI-VEGF DRUGS DURING OR AFTER PARS PLANA VITRECTOMY FOR DIABETIC MACULAR EDEMA GUIDED BY MICROSCOPE-INTEGRATED OPTICAL COHERENCE TOMOGRAPHY. Retina. 2026 Jun 1;46(6):1046-1056. doi: 10.1097/IAE.0000000000004801.
- 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.
Rongrong Zhu, master principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab Injection [Lucentis], Inner limiting membrane stripping and Dexamethasone intravitreal implant in people with Diabetic Retinopathy, run by Affiliated Hospital of Nantong University 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongrong Zhu, Master (13809089545, zrreye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Review the patient's vision before surgery (time frame: The day before the patient's surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138029, which also lists 1 linked publication.
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 1 Aug 2023.