Non Proliferative Diabetic Retinopathy(NPDR)NCT05852132
Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy
A study testing pars plana vitrectomy(PPV), Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP) and Panretinal photocoagulation(PRP) in people with Non Proliferative Diabetic Retinopathy(NPDR), run by Fei Gao at 1 site in China.
Trial summary
To investigate the prognosis of retinal structure and function after vitrectomy in patients with severe non-proliferative diabetic retinopathy, to explore the feasibility of vitrectomy in patients with severe non-proliferative diabetic retinopathy(NPDR), and to seek the best way to delay the progression of diabetic… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Proliferative Diabetic Retinopathy(NPDR)
- What is being tested?
- pars plana vitrectomy(PPV), Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP) and Panretinal photocoagulation(PRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2024to 31 Oct 2026
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, men or women
- Severe nonproliferative diabetic retinopathy was diagnosed with any one of the following, according to the International Classification of Clinical Severity of Diabetic Retinopathy: more than 20 intraretinal hemorrhaged spots in any one of four quadrants, definite venous beading in more than two quadrants, or definite intraretinal microvascular changes in more than one quadrant.
- ETDRS beat corrected visual acuity(BCVA) letter score between 19 and 78 (Snellen equivalent 20/400-20/32) on the day of randomisation.
- At least partial corneal transparency (or central corneal transparency), good pupil dilation and full cooperation with PRP, and ensure that the fundus examination, visual function examination and optical coherence tomography (OCT) examination can be performed after vitrectomy.
- Able and willing to sign informed consent
Who cannot join
- Unwilling or unable to provide consent for participation in the study, unwilling to submit to the randomisation process or unable to return for the scheduled protocol visits
- Participating in another clinical trial within the past 3 months.
- Previous intraocular laser therapy, intraocular surgery (excluding cataract surgery), or scheduled to undergo surgery within the next 6 months
- Previous poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma medication)
- Patients previously diagnosed with wet AMD, retinal vein occlusion and other neovascular retinopathy
- Patients previously diagnosed with macular membrane, ischemic optic neuropathy, uveitis and other definite fundus diseases.
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- Received pro-VEGF or anti-VEGF treatment within the past 3 months (systemic or intravitreal).
- Has a history of corticosteroid treatment (peribulbar or intravitreal) in the past 3 months
- Underwent yttrium aluminum garnet capsulotomy within the past 3 months
- Patients with intraocular fillings of silicone oil or inert gas after treatment
- Has substantial cataract that, according to the investigator's judgement, is likely to decrease visual acuity by more than three lines (ie, the cataract reduces the visual acuity to 20/40 or worse).
- Aphakic eye
- Has severe external ocular infection, including conjunctivitis and substantial blepharitis.
- Patients with severe cardiopulmonary, liver and kidney impairment and advanced cancer
- Has blood pressure >180/110 mm Hg. If blood pressure is maintained below 180/110 mm Hg with antihypertensive medication, the individual is eligible to participate
- Has a history of transient ischaemic attack, stroke, myocardial infarction, acute congestive heart failure or other acute cardiac event requiring hospitalization within the past 3 months.
- For women of childbearing age: potential study participants would be questioned about pregnant, lactating or intending to become pregnant within the next 3 years. The investigator would determine when a pregnancy test is required.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin medical university eye hospital
Tianjin
Xiaorong Li, Pro., 18622818042, xiaorli@163.com
About this study
To investigate the prognosis of retinal structure and function after vitrectomy in patients with severe non-proliferative diabetic retinopathy, to explore the feasibility of vitrectomy in patients with severe non-proliferative diabetic retinopathy(NPDR), and to seek the best way to delay the progression of diabetic retinopathy from the perspective of therapeutic effect.
Read the detailed description
Patients were randomized into three groups according to the random number table: vitrectomy group, vitrectomy + panretinal photocoagulation group and panretinal photocoagulation group alone. 1. Vitrectomy group: vitrectomy was performed for severe non-proliferative diabetic retinopathy, but retinal laser photocoagulation was not performed. 2. Vitrectomy + panretinal photocoagulation group: vitrectomy was performed for severe non-proliferative diabetic retinopathy, and retinal laser photocoagulation was performed during the operation. 3. panretinal photocoagulation group: only retinal laser photocoagulation treatment was performed for severe non-proliferative diabetic retinopathy. All patients were regularly reviewed after surgery (preoperative, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and the time and frequency of follow-up were increased according to the specific condition recovery), and the same physician assessed the retinal restoration and visual acuity recovery, and the follow-up time was not less than 12 months. The main outcome measures included the incidence of PDR, such as vitreous hemorrhage, the presence of neovascularization, fibroproliferative membranes, or traction retinal detachment. Secondary study endpoints included: (1) optimal corrected visual acuity; (2) Changes in the thickness of each retina layer; (3) Visual field changes; (4) area of retina without perfusion; (5) retinal neovascularization area; (6) the epiretinal membrane; (7) Low intraocular pressure/increased intraocular pressure, iris neovascularization and lens opacity, etc.
- Being tested
- pars plana vitrectomy(PPV), Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP), Panretinal photocoagulation(PRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomy(PPV)Procedure or surgery
Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed
Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP)Procedure or surgery
PPV was performed for severe non-proliferative diabetic retinopathy with PRP.
Panretinal photocoagulation(PRP)Procedure or surgery
Only PRP was used for severe non-proliferative diabetic retinopathy.
| Study group | Role | What they receive |
|---|---|---|
| PPV+PRP | Experimental | PPV was performed for severe non-proliferative diabetic retinopathy with PRP. Receives: Procedure: Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP) |
| Pars plana vitrectomy(PPV) | Active comparator | Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed Receives: Procedure: pars plana vitrectomy(PPV) |
| Panretinal photocoagulation(PRP) | Placebo comparator | Only PRP was used for severe non-proliferative diabetic retinopathy. Receives: Procedure: Panretinal photocoagulation(PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of proliferative diabetic retinopathy (PDR)
fluorescence fundus angiography and fundus photos are used to evaluate the fundus vessels.
Measured: 24months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start5 May 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Proliferative Diabetic Retinopathy(NPDR)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fei Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fei Gao, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852132
- Sponsor's protocol ID
- TianjinMUEHlxr0001
- Status last verified
- Mar 2024
- First submitted
- 26 Apr 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy
- ClinicalTrials.gov ID
- NCT05852132
- Acronym / sponsor ID
- TianjinMUEHlxr0001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Fei GaoUniversity, hospital or other
- Study start
- 5 May 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 May 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.
To investigate the prognosis of retinal structure and function after vitrectomy in patients with severe non-proliferative diabetic retinopathy, to explore the feasibility of vitrectomy in patients with severe non-proliferative diabetic retinopathy(NPDR), and to seek the best way to delay the progression of diabetic retinopathy from the perspective of therapeutic effect.
Detailed description
Patients were randomized into three groups according to the random number table: vitrectomy group, vitrectomy + panretinal photocoagulation group and panretinal photocoagulation group alone. 1. Vitrectomy group: vitrectomy was performed for severe non-proliferative diabetic retinopathy, but retinal laser photocoagulation was not performed. 2. Vitrectomy + panretinal photocoagulation group: vitrectomy was performed for severe non-proliferative diabetic retinopathy, and retinal laser photocoagulation was performed during the operation. 3. panretinal photocoagulation group: only retinal laser photocoagulation treatment was performed for severe non-proliferative diabetic retinopathy. All patients were regularly reviewed after surgery (preoperative, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and the time and frequency of follow-up were increased according to the specific condition recovery), and the same physician assessed the retinal restoration and visual acuity recovery, and the follow-up time was not less than 12 months. The main outcome measures included the incidence of PDR, such as vitreous hemorrhage, the presence of neovascularization, fibroproliferative membranes, or traction retinal detachment. Secondary study endpoints included: (1) optimal corrected visual acuity; (2) Changes in the thickness of each retina layer; (3) Visual field changes; (4) area of retina without perfusion; (5) retinal neovascularization area; (6) the epiretinal membrane; (7) Low intraocular pressure/increased intraocular pressure, iris neovascularization and lens opacity, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PPV+PRP | Experimental | Procedure: Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP)PPV was performed for severe non-proliferative diabetic retinopathy with PRP. |
| Pars plana vitrectomy(PPV) | Active comparator | Procedure: pars plana vitrectomy(PPV)Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed |
| Panretinal photocoagulation(PRP) | Placebo comparator | Procedure: Panretinal photocoagulation(PRP)Only PRP was used for severe non-proliferative diabetic retinopathy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years, men or women
- Severe nonproliferative diabetic retinopathy was diagnosed with any one of the following, according to the International Classification of Clinical Severity of Diabetic Retinopathy: more than 20 intraretinal hemorrhaged spots in any one of four quadrants, definite venous beading in more than two quadrants, or definite intraretinal microvascular changes in more than one quadrant.
- ETDRS beat corrected visual acuity(BCVA) letter score between 19 and 78 (Snellen equivalent 20/400-20/32) on the day of randomisation.
- At least partial corneal transparency (or central corneal transparency), good pupil dilation and full cooperation with PRP, and ensure that the fundus examination, visual function examination and optical coherence tomography (OCT) examination can be performed after vitrectomy.
- Able and willing to sign informed consent
Key exclusion criteria (17 listed)
- Unwilling or unable to provide consent for participation in the study, unwilling to submit to the randomisation process or unable to return for the scheduled protocol visits
- Participating in another clinical trial within the past 3 months.
- Previous intraocular laser therapy, intraocular surgery (excluding cataract surgery), or scheduled to undergo surgery within the next 6 months
- Previous poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma medication)
- Patients previously diagnosed with wet AMD, retinal vein occlusion and other neovascular retinopathy
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 |
|---|---|---|
| pars plana vitrectomy(PPV)Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed | Procedure or surgery | Pars plana vitrectomy(PPV) |
| Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP)PPV was performed for severe non-proliferative diabetic retinopathy with PRP. | Procedure or surgery | PPV+PRP |
| Panretinal photocoagulation(PRP)Only PRP was used for severe non-proliferative diabetic retinopathy. | Procedure or surgery | Panretinal photocoagulation(PRP) |
Primary outcome
Incidence of proliferative diabetic retinopathy (PDR)
Time frame: 24months postoperatively
fluorescence fundus angiography and fundus photos are used to evaluate the fundus vessels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pars plana vitrectomy(PPV), Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP) and Panretinal photocoagulation(PRP) in people with Non Proliferative Diabetic Retinopathy(NPDR), run by Fei Gao 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 5 inclusion and 17 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 15 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of proliferative diabetic retinopathy (PDR) (time frame: 24months 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 15 Mar 2024.