Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy

NCT05852132 | Not Yet Recruiting

• 1 other identifier: TianjinMUEHlxr0001
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief 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 retinopathy from the perspective of therapeutic effect.

Conditions

Non Proliferative Diabetic Retinopathy(NPDR)

Outcome Measures

Primary Outcomes (1)

• Incidence of proliferative diabetic retinopathy (PDR)

  fluorescence fundus angiography and fundus photos are used to evaluate the fundus vessels.

  24months postoperatively

Study Arms (3)

PPV+PRP

EXPERIMENTAL

PPV was performed for severe non-proliferative diabetic retinopathy with PRP.

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

Procedure: pars plana vitrectomy(PPV)

Panretinal photocoagulation(PRP)

PLACEBO COMPARATOR

Only PRP was used for severe non-proliferative diabetic retinopathy.

Procedure: Panretinal photocoagulation(PRP)

Interventions

pars plana vitrectomy(PPV) PROCEDURE

Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed

Pars plana vitrectomy(PPV)

Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP) PROCEDURE

PPV was performed for severe non-proliferative diabetic retinopathy with PRP.

PPV+PRP

Panretinal photocoagulation(PRP) PROCEDURE

Only PRP was used for severe non-proliferative diabetic retinopathy.

Panretinal photocoagulation(PRP)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Fei Gao: lead

Study Sites (1)

Tianjin medical university eye hospital

Tianjin, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Investigator

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 10, 2023
• Study Start: May 5, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)