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Proliferative Diabetic Retinopathy (PDR)NCT07586787

Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy

A study testing Microincision Vitrectomy Surgery and Panretinal Photocoagulation in people with Proliferative Diabetic Retinopathy (PDR), run by Xiamen Ophthalmology Center Affiliated to Xiamen University at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether early microincision vitrectomy surgery (MIVS) can improve retinal neovascularization outcomes compared to standard pan-retinal photocoagulation (PRP) in patients with early proliferative diabetic retinopathy (PDR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Proliferative Diabetic Retinopathy (PDR)
What is being tested?
Microincision Vitrectomy Surgery and Panretinal Photocoagulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesChina
Study dates
1 Jan 2025to 10 Jun 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

  • Age 18 years or older.
  • Diagnosis of type 2 diabetes mellitus.
  • Presence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does not interfere with evaluation of neovascularization.
  • Relatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal photocoagulation and retinal imaging.
  • Ability and willingness to provide written informed consent.
  • If both eyes are eligible, the eye with worse vision will be included.

Who cannot join

  • Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye.
  • Retinal traction or retinal detachment.
  • Optic neuropathy.
  • Macular edema caused by reasons other than diabetes.
  • Coexisting ocular disease that may decrease visual acuity during the study.
  • Substantial cataract likely to decrease visual acuity by more than three lines.
Show all 19Show fewer
  • Major ocular surgery within the past 4 months or planned intraocular surgery within the next 6 months.
  • YAG capsulotomy within the past 2 months.
  • Any intravitreal injection within the past 3 months.
  • Aphakia.
  • Severe external ocular infection.
  • Uncontrolled glaucoma.
  • Significant renal disease requiring dialysis or kidney transplantation.
  • Unstable glycemic control.
  • Blood pressure greater than 180/110 mmHg.
  • History of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac event requiring hospitalization within the past 4 months.
  • Pregnant, lactating, or intending to become pregnant during the study period.
  • Participation in another clinical trial.
  • Unwilling or unable to provide informed consent, undergo randomization, or return for scheduled visits.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

China6 sites, 1 recruiting
  • Peking University People's Hospital

    Beijing, Beijing Municipality

    Completed
  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Completed
  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

    Completed
  • Nanjing Medical University affiliated Eye Hospital

    Nanjing, Jiangsu

    Completed
  • Xiamen Eye Center of Xiamen University

    Xiamen, Fujian, 361000

    Xiuju Chen, MD, 15121013344, joyychen@aliyun.com

    Xiaoxin Li, PhD

    Recruiting
  • Henan Province People's Hospital

    Zhengzhou, Henan

    Completed

Other trials in China

About this study

Official title: Comparison of Early Micro-invasive Vitrectomy Surgery Versus Panretinal Photocoagulation for the Treatment of Early Proliferative Diabetic Retinopathy: A Multi-center Randomized Trial

The goal of this clinical trial is to learn whether early microincision vitrectomy surgery (MIVS) can improve retinal neovascularization outcomes compared to standard pan-retinal photocoagulation (PRP) in patients with early proliferative diabetic retinopathy (PDR). It will also evaluate the safety and functional outcomes of early surgical intervention in this population.

The main questions it aims to answer are:

Read more

Does early MIVS increase the proportion of eyes achieving complete regression of retinal neovascularization at 12 months? Does early MIVS improve visual and functional outcomes, including visual acuity and visual field, compared to PRP? Researchers will compare early MIVS combined with peripheral scatter photocoagulation to standard PRP to determine whether early surgical intervention leads to better regression of neovascularization and improved clinical outcomes.

Participants will:

Receive either MIVS with peripheral photocoagulation or standard PRP Undergo retinal imaging assessments including fundus fluorescein angiography (FFA) or optical coherence tomography angiography (OCTA) Complete follow-up visits over 12 months, including visual acuity testing, visual field testing, and optical coherence tomography (OCT) imaging Be monitored for the occurrence of vitreous hemorrhage and other clinical outcomes

Read the detailed description

Diabetic retinopathy is a leading cause of vision impairment worldwide, particularly among working-age adults. The development of retinal neovascularization in proliferative diabetic retinopathy (PDR), including neovascularization at the disc (NVD) and neovascularization elsewhere (NVE), is associated with a high risk of vitreous hemorrhage, tractional retinal detachment, and severe vision loss.

Current standard treatment for early PDR includes panretinal photocoagulation (PRP) with or without adjunctive anti-vascular endothelial growth factor (anti-VEGF) therapy. While PRP has been shown to reduce the risk of severe vision loss, it is associated with several limitations, including peripheral visual field loss, reduced night vision, exacerbation of macular edema, and incomplete regression of neovascularization in a substantial proportion of patients. Anti-VEGF therapy requires repeated intravitreal injections and may be associated with treatment burden and variable response.

The vitreous body plays an important role in the pathophysiology of PDR by providing a scaffold for neovascular growth and contributing to the persistence of vascular endothelial growth factor (VEGF) within the vitreous cavity. Microincision vitrectomy surgery (MIVS) may offer potential therapeutic advantages by removing the vitreous scaffold, facilitating the clearance of VEGF, and improving intraocular oxygenation. These mechanisms may contribute to more effective regression of retinal neovascularization and reduction in disease progression.

This study is a multicenter, prospective trial designed to compare early MIVS intervention with standard PRP in patients with early PDR. Eligible participants will receive either MIVS combined with peripheral photocoagulation or standard PRP. The surgical procedure will be performed using small-gauge (25G or 27G) instrumentation with high-speed vitreous removal. In the experimental group, scattered photocoagulation will be applied to the far peripheral retina during surgery. In the control group, PRP will be delivered in accordance with standard clinical practice over multiple sessions.

Participants will undergo standardized follow-up evaluations over 12 months. Retinal neovascularization will be assessed using fundus fluorescein angiography (FFA) or optical coherence tomography angiography (OCTA). Functional outcomes, including best corrected visual acuity (BCVA) and visual field cumulated values , will be measured using standardized protocols. Structural outcomes such as central retinal thickness will be assessed by optical coherence tomography (OCT).

To enhance the reliability of outcome assessment, retinal imaging will be obtained using standardized acquisition protocols and evaluated by trained graders when feasible.

This study aims to generate clinical evidence on whether early surgical intervention with MIVS can improve neovascular regression and functional outcomes compared with PRP alone in early PDR, thereby informing optimal treatment strategies for this patient population.

Being tested
Microincision Vitrectomy Surgery, Panretinal Photocoagulation
Keywords
Panretinal photocoagulation, Proliferative diabetic retinopathy, Retinal neovascularization, Vitrectomy
Medical subject headings
Retinal Neovascularization

What participants receive

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

  • Microincision Vitrectomy SurgeryProcedure or surgery

    Also called Panretinal Photocoagulation

    Panretinal photocoagulation delivered using standard laser therapy, consisting of approximately 1000 to 1500 laser burns applied over one or two sessions according to routine clinical practice.

  • Panretinal PhotocoagulationProcedure or surgery

    Panretinal photocoagulation delivered using standard laser therapy, consisting of approximately 1000 to 1500 laser burns applied over one or two sessions according to routine clinical practice.

Study groups in NCT07586787
Study groupRoleWhat they receive
Microincision Vitrectomy SurgeryExperimentalParticipants undergo early microincision vitrectomy surgery (MIVS) using small-gauge instrumentation (25G or 27G) with high-speed vitreous removal. During surgery, scattered photocoagulation is applied to the far peripheral retina.
Receives: Procedure: Microincision Vitrectomy Surgery
Panretinal PhotocoagulationActive comparatorParticipants receive standard panretinal photocoagulation (PRP) according to routine clinical practice. Treatment consists of approximately 1000 to 1500 laser burns delivered over one or two sessions within several weeks after randomization.
Receives: Procedure: Panretinal Photocoagulation

What is being measured

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

  1. Proportion of Eyes With Complete Regression of Neovascularization

    Complete regression is defined as absence of neovascularization at the disc or neovascularization elsewhere in the retina, assessed by fundus fluorescein angiography or optical coherence tomography angiography.

    Measured: 12 months

Secondary outcomes (4)
  1. Proportion of Eyes With Partial Regression of Neovascularization

    Partial regression is defined as reduction in retinal neovascularization compared with baseline, assessed by fundus fluorescein angiography or optical coherence tomography angiography.

    Measured: 12 months

  2. Incidence of Vitreous Hemorrhage

    Incidence of vitreous hemorrhage through 6/12 months after treatment.

    Measured: 6 months;12 months

  3. Change in Visual Field

    Change in visual field cumulative values measured using the 60-degree visual field test.

    Measured: Baseline to 12 months

  4. Change in Best Corrected Visual Acuity

    Change in best corrected visual acuity measured using an ETDRS LogMAR chart.

    Measured: Baseline to 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 posted14 May 2026
  2. Study start1 Jan 2025
  3. Primary completion10 Jun 2026 (estimated)
  4. Study completion10 Jun 2026 (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
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586787
Sponsor's protocol ID
XMYKZX-KY-2024-061
Other IDs
IIT-92241613
Status last verified
May 2026
First submitted
7 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly available but may be shared upon reasonable request and with approval from the study sponsor and institutional review board.

Publications

  • Simpson AR, Dowell NG, Jackson TL, Tofts PS, Hughes EH. Measuring the effect of pars plana vitrectomy on vitreous oxygenation using magnetic resonance imaging. Invest Ophthalmol Vis Sci. 2013 Mar 21;54(3):2028-34. doi: 10.1167/iovs.12-11258.

    PubMed 23439600
  • Jones CH, Gui W, Schumann RG, Boneva S, Lange CA, van Overdam K, Chui TY, Rosen RB, Engelbert M, Sebag J. Hyalocytes in proliferative vitreo-retinal diseases. Expert Rev Ophthalmol. 2022;17(4):263-280. doi: 10.1080/17469899.2022.2100764. Epub 2022 Sep 6.

    PubMed 36466118
  • Vaz-Pereira S, Dansingani KK, Chen KC, Cooney MJ, Klancnik JM Jr, Engelbert M. TOMOGRAPHIC RELATIONSHIPS BETWEEN RETINAL NEOVASCULARIZATION AND THE POSTERIOR VITREOUS IN PROLIFERATIVE DIABETIC RETINOPATHY. Retina. 2017 Jul;37(7):1287-1296. doi: 10.1097/IAE.0000000000001336.

    PubMed 27749694
  • Gawecki M, Kicinski K, Bianco L, Battaglia Parodi M. Regression of Neovascularization after Panretinal Photocoagulation Combined with Anti-VEGF Injection for Proliferative Diabetic Retinopathy-A Review. Diagnostics (Basel). 2023 Dec 22;14(1):31. doi: 10.3390/diagnostics14010031.

    PubMed 38201340
  • Bahr TA, Bakri SJ. Update on the Management of Diabetic Retinopathy: Anti-VEGF Agents for the Prevention of Complications and Progression of Nonproliferative and Proliferative Retinopathy. Life (Basel). 2023 Apr 27;13(5):1098. doi: 10.3390/life13051098.

    PubMed 37240743
  • Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33.

    PubMed 2062515
  • Berrocal MH, Acaba-Berrocal L. Early pars plana vitrectomy for proliferative diabetic retinopathy: update and review of current literature. Curr Opin Ophthalmol. 2021 May 1;32(3):203-208. doi: 10.1097/ICU.0000000000000760.

    PubMed 33770016

Questions about this trial

What is this clinical trial studying?

A study testing Microincision Vitrectomy Surgery and Panretinal Photocoagulation in people with Proliferative Diabetic Retinopathy (PDR), run by Xiamen Ophthalmology Center Affiliated to Xiamen University at 6 sites 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 6 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Contact xiuju Chen, md (+8618060955810, joyychen@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eyes With Complete Regression of Neovascularization (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 NCT07586787, which also lists 7 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 14 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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