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Non Proliferative Diabetic RetinopathyNCT04103671

Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe NPDR

A study testing Prompt panretinal photocoagulation and 25G Pars-plana vitrectomy in people with Non Proliferative Diabetic Retinopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It is estimated that there are about 600 million diabetes mellitus (DM) patients all over the world until 2040，and almost 50% of whom have some degree of diabetic retinopathy (DR) at any given time. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Proliferative Diabetic Retinopathy
What is being tested?
Prompt panretinal photocoagulation and 25G Pars-plana vitrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
1 siteChina
Study dates
4 Dec 2019to 31 Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years, male or female
  • Type 1 or type 2 diabetes
  • Presence of severe NPDR according to the diagnosis of 4-2-1 rule,
  • One or more of the following, in the absence of PDR:
  • More than 20 intraretinal hemorrhages in each of four quadrants
  • Definite venous beading in two or more quadrants
Show all 10Show fewer
  • Prominent intraretinal microvascular abnormality (IRMA) in one or more quadrants
  • Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score > 24 (approximate Snellen equivalent 20/320) on the day of randomization.
  • Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).
  • Able and willing to provide informed consent

Who cannot join

  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
  • In the opinion of the investigator, A condition that would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
  • Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
  • If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
Show all 21Show fewer
  • Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization
  • These drugs should not be used during the study
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
  • Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed
  • History of prior panretinal photocoagulation (prior PRP is defined as ≥100 burns outside of the posterior pole
  • If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema.
  • An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal).
  • History of intravitreal anti-VEGF treatment at any time in the past 2 months
  • History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months.
  • History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • History of laser capsulotomy performed within 2 months prior to randomization
  • Aphakia.
  • Uncontrolled glaucoma (in investigator's judgment).
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Trial locations and contacts

1 site in 1 country.

tao li, Dr contact

66683995 ext. +8620

litao2@mail.sysu.edu.cn

shida chen, Dr contact

66610721 ext. +8620

chenshd3@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510060

    shida chen, +862066683995, chenshd3@mail.sysu.edu.cn

    lin lu, +862066683995, lulin888@126.com

    Recruiting

Other trials in China

About this study

Official title: Micro-invasive Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe Non-Proliferative Diabetic Retinopathy A Randomized Clinical Trial

It is estimated that there are about 600 million diabetes mellitus (DM) patients all over the world until 2040，and almost 50% of whom have some degree of diabetic retinopathy (DR) at any given time. About 5% to 10% diabetic retinopathy would develop vision-threatening complications, including proliferative diabetic retinopathy (PDR), capillary non-perfusion, or macular edema. Data from the DRS suggest that given long enough duration of diabetes, approximately 60% of patients with DR will develop PDR, and without intervention, 75% nonproliferative diabetic retinopathy (NPDR) will development PDR within 1 year follow up, 45% will develop high-risk PDR, nearly half of PDR will experience profound visual loss. panretinal photocoagulation (PRP) only reduced 50% risk of sever visual loss and about 25% of the sNPDR patients who finished PRP need Pars-plana vitrectomy (PPV) in a 5 year follow up.

Vitreous have been proven to play an important role in the development of NPDR to PDR, which were the collection of vascular endothelial growth factor (VEGF) factors and the major component of proliferative lesion in the later stage of PDR.

Micro-invasive Pars-plana vitrectomy has been shown as a safe and effective method in the treatment of PDR, through removing the pathological vitreous, proliferative membrane and also the VEGF factors. However, whether or not Micro-invasive Pars-plana vitrectomy will be more effective than PRP to control the progression of NDPR remained unknown.

Being tested
Prompt panretinal photocoagulation, 25G Pars-plana vitrectomy
Keywords
NPDR, Pars-plana vitrectomy, panretinal photocoagulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prompt panretinal photocoagulationProcedure or surgery

    Study eyes that receive panretinal photocoagulation (prompt PRP eyes at baseline) should have 1200 to1600 burns with a spot size on the retina of approximately 500 microns given over 1 to 3 sittings and completed within 4 weeks of initiation

  • 25G Pars-plana vitrectomyProcedure or surgery

    Study eyes that receive standard 25G Pars-plana vitrectomy that remove all the vitreous, without laser or Silicone oil tamponade, but filled with perfusion fluid. Surgery should be completed within 4 weeks after randomization.

Study groups in NCT04103671
Study groupRoleWhat they receive
Group AExperimentalPrompt panretinal photocoagulation
Receives: Procedure: Prompt panretinal photocoagulation
Group BExperimentalMicro-invasive Pars-plana vitrectomy
Receives: Procedure: 25G Pars-plana vitrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression rate of severe non proliferative diabetic retinopathy

    the number of patients with severe non proliferative diabetic retinopathy progressed to proliferative diabetic retinopathy in each group from the baseline to 12 months

    Measured: 12 months

Secondary outcomes (7)

  1. the change of best corrected visual acuity

    The mean change in best corrected visual acuity in each group from baseline to 12 months

    Measured: 12 months

  2. the rate of re-treatment

    The number of patients who need re-treatment including supplement laser or vitrectomy from baseline to 12 months

    Measured: 12 months

  3. The occurrence of diabetic macular edema

    The occurrence number of diabetic macular edema in each group from baseline to 12 months

    Measured: 12 months

  4. The change of central retinal thickness

    the change of central retinal thickness from baseline to 12 months

    Measured: 12 months

  5. The change of visual field

    the change of visual field from baseline to 12 months

    Measured: 12 months

  6. The occurrence of cataract

    the occurrence of cataract from baseline to 12 months

    Measured: 12 months

  7. The change of quality of life

    the change of quality of life as assessed by questionnaire at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start4 Dec 2019
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103671
Sponsor's protocol ID
2019KYPJ108
Status last verified
Mar 2023
First submitted
23 Sep 2019
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin Z, Zheng W, Ding X, Liu B, Jin L, Lai K, Xiao S, Lin Y, Liu B, Li J, Ma Y, Wu Y, Liu Y, Meng Y, Li Y, Chen S, Li T. Microinvasive pars plana vitrectomy versus panretinal photocoagulation for severe non-proliferative diabetic retinopathy: a randomised controlled trial. Br J Ophthalmol. 2026 Jul 17:bjo-2025-328536. doi: 10.1136/bjo-2025-328536. Online ahead of print.

    PubMed 42469016

  • Zheng W, Chen S, Ding X, Lai K, Xiao S, Lin Y, Liu B, Jin L, Li J, Wu Y, Ma Y, Lu L, Liu Y, Li T. Microinvasive pars plana vitrectomy versus panretinal photocoagulation in the treatment of severe non-proliferative diabetic retinopathy (the VIP study): study protocol for a randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e043371. doi: 10.1136/bmjopen-2020-043371.

    PubMed 33619191

Questions about this trial

What is this clinical trial studying?

A study testing Prompt panretinal photocoagulation and 25G Pars-plana vitrectomy in people with Non Proliferative Diabetic Retinopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 10 inclusion and 21 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 30 Mar 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.

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 tao li, Dr (66683995 ext. +8620, litao2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression rate of severe non proliferative diabetic retinopathy (time frame: 12 months). 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 NCT04103671, which also lists 2 linked publications.

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 30 Mar 2023.

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