Diabetic Macular EdemaPhase 4NCT05990829
Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial
A Phase 4 study testing Ozurdex and Aflibercept in people with Diabetic Macular Edema and Pars Plana Vitrectomy, run by Tianjin Medical University Eye Hospital at 1 site in China.
Trial summary
Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Pars Plana Vitrectomy, Dexamethasone Intravitreal Implant
- What is being tested?
- Ozurdex and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age;
- Patients and their families fully understand the research and must sign an informed consent form;
- Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination;
- Haemoglobin A1c (HbA1c) levels of <10% within 3 months;
- No contraindication of vitrectomy;
- Pseudophakia or this operation is combined with phacoemulsification and lens implantation;
- Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy
Who cannot join
- The follow-up period is less than 6 months;
- Patients need gas or silicon oil tamponade;
- Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis;
- Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule);
- Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion);
- Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF injection one month prior to screening;
- Patients with uncontrolled systemic disease
Trial locations and contacts
1 site in 1 country.
Bojie Hu contact
China1 site, 1 recruiting
- Recruiting
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality
Bojie Hu, 13612130943, bhu07@tmu.edu.cn
About this study
Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.
- Conditions
- Diabetic Macular Edema, Pars Plana Vitrectomy, Dexamethasone Intravitreal Implant, Intraoperative Optical Coherence Tomography
- Being tested
- Ozurdex, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.
AfliberceptDrug
Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex group | Experimental | Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery. Receives: Drug: Ozurdex |
| Aflibercept group | Active comparator | Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in central foveal thickness (CFT)
Three-dimensional swept source optical coherence tomography (SS-OCT)
Measured: 1, 3, 6 month postoperatively
Secondary outcomes (2)
Average change in best corrected visual acuity (BCVA)
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Measured: 1, 3, 6 month postoperatively
Number of reinjections
Each participant will receive pro re nata therapy, with regular monitoring for 6 months, at least 3 months apart for the study group and 1 month apart for the control group. Further treatment will be performed if the following criteria are met: (1) existence of recent or persisting cystoid retinal lesions; (2) a decrease of no less than 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in BCVA; and (3) an increase of 50 m or more in central foveal thickness (CFT) compared with the best value previously achieved.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular 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
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Bojie Hu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990829
- Sponsor's protocol ID
- TianjinMUEHhbj001
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05990829
- Acronym / sponsor ID
- TianjinMUEHhbj001
- Conditions
- Diabetic Macular Edema, Pars Plana Vitrectomy, Dexamethasone Intravitreal Implant, Intraoperative Optical Coherence Tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozurdex group | Experimental | Drug: OzurdexStandard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery. |
| Aflibercept group | Active comparator | Drug: AfliberceptStandard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age;
- Patients and their families fully understand the research and must sign an informed consent form;
- Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination;
- Haemoglobin A1c (HbA1c) levels of <10% within 3 months;
- No contraindication of vitrectomy;
Key exclusion criteria (7 listed)
- The follow-up period is less than 6 months;
- Patients need gas or silicon oil tamponade;
- Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis;
- Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule);
- Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion);
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 |
|---|---|---|
| OzurdexStandard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery. | Drug | Ozurdex group |
| AfliberceptStandard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery. | Drug | Aflibercept group |
Primary outcome
Average change in central foveal thickness (CFT)
Time frame: 1, 3, 6 month postoperatively
Three-dimensional swept source optical coherence tomography (SS-OCT)
2 secondary outcomes
Average change in best corrected visual acuity (BCVA)
Time frame: 1, 3, 6 month postoperatively
Number of reinjections
Time frame: 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
Bojie Hu contact
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 Ozurdex and Aflibercept in people with Diabetic Macular Edema and Pars Plana Vitrectomy, run by Tianjin Medical University Eye 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 7 inclusion and 7 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 6 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojie Hu (bhu07@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in central foveal thickness (CFT) (time frame: 1, 3, 6 month postoperatively). 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 6 Mar 2024.