Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Comparison of Early Micro-invasive Vitrectomy Surgery Versus Panretinal Photocoagulation for the Treatment of Early Proliferative Diabetic Retinopathy: A Multi-center Randomized Trial
2 other identifiers
interventional
100
1 country
6
Brief 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). It will also evaluate the safety and functional outcomes of early surgical intervention in this population. The main questions it aims to answer are: 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 10, 2026
May 14, 2026
May 1, 2026
1.4 years
May 7, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 months
Secondary Outcomes (4)
Proportion of Eyes With Partial Regression of Neovascularization
12 months
Incidence of Vitreous Hemorrhage
6 monthsï¼›12 months
Change in Visual Field
Baseline to 12 months
Change in Best Corrected Visual Acuity
Baseline to 12 months
Study Arms (2)
Microincision Vitrectomy Surgery
EXPERIMENTALParticipants 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.
Panretinal Photocoagulation
ACTIVE 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Ophthalmology Center Affiliated to Xiamen Universitylead
- Jiangsu Provincial People's Hospitalcollaborator
- Peking University People's Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- Nanjing Medical Universitycollaborator
- The First Affiliated Hospital of Dalian Medical Universitycollaborator
Study Sites (6)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Xiamen Eye Center of Xiamen University
Xiamen, Fujian, 361000, China
Henan Province People's Hospital
Zhengzhou, Henan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Nanjing Medical University affiliated Eye Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Related Publications (7)
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.
PMID: 23439600BACKGROUNDJones 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.
PMID: 36466118BACKGROUNDVaz-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.
PMID: 27749694BACKGROUNDGawecki 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.
PMID: 38201340BACKGROUNDBahr 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.
PMID: 37240743BACKGROUNDFundus 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.
PMID: 2062515BACKGROUNDBerrocal 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.
PMID: 33770016BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoxin Li, PhD
Xiamen Eye Center of Xiamen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 14, 2026
Study Start
January 1, 2025
Primary Completion (Estimated)
June 10, 2026
Study Completion (Estimated)
June 10, 2026
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.