Comparing two treatments for severe non-proliferative diabetic retinopathy

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

This study is testing which treatment, either surgery or laser therapy, works better to stop severe non-proliferative diabetic retinopathy from getting worse and causing vision loss.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04103671 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effectiveness of two interventions, pars-plana vitrectomy and panretinal photocoagulation, for patients suffering from severe non-proliferative diabetic retinopathy (NPDR). The study aims to determine which treatment better prevents the progression of NPDR to more severe forms of diabetic retinopathy, which can lead to vision loss. Participants will be randomly assigned to receive either treatment and will be monitored for visual outcomes over time. The trial focuses on patients who meet specific criteria related to their diabetes and eye health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with type 1 or type 2 diabetes and severe NPDR as defined by specific clinical criteria.

Not a fit: Patients with significant renal disease or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with severe NPDR, potentially reducing the risk of vision loss.

How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of treatments for severe NPDR is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥18 years, male or female
2. Type 1 or type 2 diabetes
3. 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
   * Prominent intraretinal microvascular abnormality (IRMA) in one or more quadrants
4. 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.
5. Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).
6. Able and willing to provide informed consent

Exclusion Criteria:

1. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
2. 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).
3. 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.
4. 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.
5. 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
6. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization

   \* These drugs should not be used during the study
7. 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
8. History of prior panretinal photocoagulation (prior PRP is defined as ≥100 burns outside of the posterior pole
9. If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema.
10. 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.).
11. 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).
12. History of intravitreal anti-VEGF treatment at any time in the past 2 months
13. History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months.
14. 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.
15. History of laser capsulotomy performed within 2 months prior to randomization
16. Aphakia.
17. Uncontrolled glaucoma (in investigator's judgment).
18. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Where this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: tao li, Dr

Conditions: Non Proliferative Diabetic Retinopathy, NPDR, Pars-plana vitrectomy, panretinal photocoagulation