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Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy

Primary Purpose

Non Proliferative Diabetic Retinopathy(NPDR)

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pars plana vitrectomy(PPV)
Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP)
Panretinal photocoagulation(PRP)
Sponsored by
Fei Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Proliferative Diabetic Retinopathy(NPDR)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Has a history of transient ischaemic attack, stroke, myocardial infarction, acute congestive heart failure or other acute cardiac event requiring hospitalization within the past 3 months. For women of childbearing age: potential study participants would be questioned about pregnant, lactating or intending to become pregnant within the next 3 years. The investigator would determine when a pregnancy test is required.

Sites / Locations

  • Tianjin medical university eye hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

PPV+PRP

Pars plana vitrectomy(PPV)

Panretinal photocoagulation(PRP)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of proliferative diabetic retinopathy (PDR)
fluorescence fundus angiography and fundus photos are used to evaluate the fundus vessels.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2023
Last Updated
May 10, 2023
Sponsor
Fei Gao
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1. Study Identification

Unique Protocol Identification Number
NCT05852132
Brief Title
Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy
Official Title
Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fei Gao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients were randomized into three groups according to the random number table: vitrectomy group, vitrectomy + panretinal photocoagulation group and panretinal photocoagulation group alone. 1. Vitrectomy group: vitrectomy was performed for severe non-proliferative diabetic retinopathy, but retinal laser photocoagulation was not performed. 2. Vitrectomy + panretinal photocoagulation group: vitrectomy was performed for severe non-proliferative diabetic retinopathy, and retinal laser photocoagulation was performed during the operation. 3. panretinal photocoagulation group: only retinal laser photocoagulation treatment was performed for severe non-proliferative diabetic retinopathy. All patients were regularly reviewed after surgery (preoperative, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and the time and frequency of follow-up were increased according to the specific condition recovery), and the same physician assessed the retinal restoration and visual acuity recovery, and the follow-up time was not less than 12 months. The main outcome measures included the incidence of PDR, such as vitreous hemorrhage, the presence of neovascularization, fibroproliferative membranes, or traction retinal detachment. Secondary study endpoints included: (1) optimal corrected visual acuity; (2) Changes in the thickness of each retina layer; (3) Visual field changes; (4) area of retina without perfusion; (5) retinal neovascularization area; (6) the epiretinal membrane; (7) Low intraocular pressure/increased intraocular pressure, iris neovascularization and lens opacity, etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Proliferative Diabetic Retinopathy(NPDR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
249 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PPV+PRP
Arm Type
Experimental
Arm Description
PPV was performed for severe non-proliferative diabetic retinopathy with PRP.
Arm Title
Pars plana vitrectomy(PPV)
Arm Type
Active Comparator
Arm Description
Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed
Arm Title
Panretinal photocoagulation(PRP)
Arm Type
Placebo Comparator
Arm Description
Only PRP was used for severe non-proliferative diabetic retinopathy.
Intervention Type
Procedure
Intervention Name(s)
pars plana vitrectomy(PPV)
Intervention Description
Vitrectomy was performed for severe non-proliferative diabetic retinopathy, but panretinal photocoagulation(PRP) was not performed
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy(PPV) +Panretinal photocoagulation(PRP)
Intervention Description
PPV was performed for severe non-proliferative diabetic retinopathy with PRP.
Intervention Type
Procedure
Intervention Name(s)
Panretinal photocoagulation(PRP)
Intervention Description
Only PRP was used for severe non-proliferative diabetic retinopathy.
Primary Outcome Measure Information:
Title
Incidence of proliferative diabetic retinopathy (PDR)
Description
fluorescence fundus angiography and fundus photos are used to evaluate the fundus vessels.
Time Frame
24months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Has a history of transient ischaemic attack, stroke, myocardial infarction, acute congestive heart failure or other acute cardiac event requiring hospitalization within the past 3 months. For women of childbearing age: potential study participants would be questioned about pregnant, lactating or intending to become pregnant within the next 3 years. The investigator would determine when a pregnancy test is required.
Facility Information:
Facility Name
Tianjin medical university eye hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaorong Li, Pro.
Phone
18622818042
Email
xiaorli@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy

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