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Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05408416
Recruitment Status : Completed
First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).Intravitreal injection of anti-VEGF drugs is a good adjunct to vitreous surgery for severe PDR. Some studies have confirmed that the application of anti-VEGF drugs before vitrectomy for PDR patients can reduce the difficulty of surgery and improve postoperative best corrected visual acuity (BCVA), but very few researches focused on the injections of anti-VEGF during surgery.Therefore, investigators carry out this clinical trial to compare the effects of preoperative and intraoperative intravitreal injections of ranibizumab (IVR) on vitrectomy outcomes for PDR patients.One group receive ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy. Another group receive ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy. Intraoperative and postoperative indices are collected for further comparison.Investigators enroll PDR patients whose baseline characteristics including age, sex, BMI, type of diabetes, HbA1c level, duration of DM, hypertension, previous history of laser photocoagulation, status of lens, indication for surgery, baseline BCVA, IOP, baseline CRT and extent of VAG are comparable.The enrolled eyes are randomly assigned according to the Central Randomization System with a ratio of 1:1 to preoperative IVR group and intraoperative IVR group. Intraoperative including surgery time, intraoperative bleeding, intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade, and postoperative indices including postoperative best-corrected visual acuity (BCVA), central retinal thickness (CRT), postoperative vitreous hemorrhage (VH), neovascular glaucoma (NVG), recurrent retinal detachment, postoperative fibrovascular proliferation progression and reoperationare collected for further comparison.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Procedure: preoperative group and intraoperative group Not Applicable

Detailed Description:
Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).It is characterized by progressive loss of vision, retinal edema, vitreous hemorrhage (VH), retinal neovascularization, fibrovascular proliferation, tractional retinal detachment (TRD) and neovascular glaucoma (NVG).Although pars plana vitrectomy (PPV) is the cornerstone for treatment of advanced PDR, related postoperative complications such as recurrent VH, NVG, and progressive fibrovascular proliferation may still cause serious visual impairment.It is well known that vascular endothelial growth factor (VEGF) is a leading role of the neovascularization, vascular permeability, and diabetic macular edema.Intravitreal injection of anti-VEGF drugs before or during PPV maybe a good adjunct to vitreous surgery for severe PDR. Some studies have confirmed that the application of anti-VEGF drugs before vitrectomy for PDR patients can reduce the difficulty of surgery and improve postoperative best corrected visual acuity (BCVA),but very few researches focused on the injections of anti-VEGF during surgery.Therefore, investigators carried out this study to compare the effects of preoperative and intraoperative intravitreal injections of ranibizumab (IVR) on vitrectomy outcomes for PDR patients.Investigators enroll PDR patients whose baseline characteristics including age, sex, BMI, type of diabetes, HbA1c level, duration of DM, hypertension, previous history of laser photocoagulation, status of lens, indication for surgery, baseline BCVA, IOP, baseline CRT and extent of VAG are comparable.The enrolled eyes are randomly assigned according to the Central Randomization System with a ratio of 1:1 to preoperative IVR group and intraoperative IVR group. Intraoperative and postoperative indices are collected for further comparison. Intraoperative indices including surgery time, intraoperative bleeding, intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade. Investigators compare whether there are statistical differences in the above indicators between the two groups. Meanwhile, postoperative indices are collected during 1week, 1 month, 3 month follow-up, including best-corrected visual acuity (BCVA), central retinal thickness (CRT), postoperative vitreous hemorrhage (VH), neovascular glaucoma (NVG), recurrent retinal detachment, postoperative fibrovascular proliferation progression and reoperation. Investigators compare whether there are statistical differences in the above indicators between the two groups at different visit time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Surgery Outcome Between Preoperative and Intraoperative Intravitreal Injection of Ranibizumab for Vitrectomy in Proliferative Diabetic Retinopathy Patients
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : May 29, 2022
Actual Study Completion Date : May 29, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: preoperative group
PDR patients who received ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy were assigned to preoperative group
Procedure: preoperative group and intraoperative group
ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy or ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy

Experimental: intraoperative group
PDR patients who received ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy were assigned to intraoperative group
Procedure: preoperative group and intraoperative group
ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy or ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy




Primary Outcome Measures :
  1. best-corrected visual acuity (BCVA) [ Time Frame: from preoperation to 3 months follow-up ]
    every visit time

  2. central retinal thickness [ Time Frame: from preoperation to 3 months follow-up ]
    every visit time


Secondary Outcome Measures :
  1. surgery time [ Time Frame: during surgery ]
    intraoperative index

  2. intraoperative bleeding [ Time Frame: during surgery ]
    intraoperative index

  3. intraocular electrocoagulation use [ Time Frame: during surgery ]
    intraoperative index

  4. iatrogenic retinal breaks [ Time Frame: during surgery ]
    intraoperative index

  5. relaxing retinotomy [ Time Frame: during surgery ]
    intraoperative index

  6. silicone oil tamponade [ Time Frame: during surgery ]
    intraoperative index

  7. postoperative vitreous hemorrhage [ Time Frame: during 3 months follow-up ]
    postoperative index

  8. neovascular glaucoma [ Time Frame: during 3 months follow-up ]
    postoperative index

  9. recurrent retinal detachment [ Time Frame: during 3 months follow-up ]
    postoperative index

  10. postoperative fibrovascular proliferation progression [ Time Frame: during 3 months follow-up ]
    postoperative index

  11. reoperation [ Time Frame: during 3 months follow-up ]
    postoperative index



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with PDR;
  • persistent VH for more than 1 month or recurrent VH with or without panretinal photocoagulation (PRP);
  • TRD detected by indirect ophthalmoscope or B-scan ultrasonography.

Exclusion Criteria:

  • previous vitrectomy or intravitreal injection in the study eyes;
  • eyes with any ocular disease that may hinder visual improvement other than PDR, such as optic atrophy or macular hole;
  • poor control of diabetes mellitus (DM) with hemoglobin A1c (HbA1c) > 12%;
  • history of thromboembolic events (including cerebral vascular infarctions or myocardial infarctions) or coagulation system disorders or receiving anticoagulant or antiplatelet therapy;
  • eyes given gas tamponade or additional treatment during follow-up periods.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05408416


Locations
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China, Beijing
People's Hospital of Peking University
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Chair: Jinfeng Qu, MD Peking University People's Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05408416    
Other Study ID Numbers: PekingUPHJinfeng Qu
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
pars plana vitrectomy
ranibizumab
preoperative intravitreal injection
intraoperative intravitreal injection
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases