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Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
preoperative intravitreal injections of ranibizumab or conbercept
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative diabetic retinopathy; ranibizumab; conbercept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with diabetic retinopathy (DR); hemoglobin A1c (HbA1c) ≤ 12%;
  • persistent VH for more than 1 month or recurrent vitreous hemorrhage (VH) with or without panretinal photocoagulation (PRP);
  • TRD detected by indirect ophthalmoscope or B-scan ultrasonography.

Exclusion Criteria:

  • previous vitreoretinal surgeries (including vitrectomy, intravitreal drug 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;
  • 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 like ranibizumab injection again or supplementary retinal photocoagulation during follow-up periods.

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IVR group

IVC group

Arm Description

Patients that received intravitreal ranibizumab injections (IVR) (0.5mg/0.05ml) before vitreous surgery were assigned to IVR group 3-5 days before three-port transconjunctival 25-G pars plana vitrectomy (PPV). All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge Constellation system (Alcon, Fort Worth, TX, USA) system under local or anesthesia. A speed of 5000 cuts per minute was used for vitrectomy.

Patients that received intravitreal conbercept injection (IVC) (0.5mg/0.05ml) before vitreous surgery were assigned to IVC group 3-5 days before three-port transconjunctival 25-G pars plana vitrectomy (PPV). All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge Constellation system (Alcon, Fort Worth, TX, USA) system under local or anesthesia. A speed of 5000 cuts per minute was used for vitrectomy.

Outcomes

Primary Outcome Measures

BCVA
best-corrected visual acuity
CRT
central retinal thickness

Secondary Outcome Measures

surgery time
surgery time
intraoperative bleeding
intraoperative bleeding
intraocular electrocoagulation use
intraocular electrocoagulation use
incidence of iatrogenic retinal breaks
incidence of iatrogenic retinal breaks
relaxing retinotomy
relaxing retinotomy
retinal reattachment
retinal reattachment
silicone oil tamponade
silicone oil tamponade
postoperative vitreous hemorrhage (VH)
postoperative vitreous hemorrhage (VH)
neovascular glaucoma (NVG)
neovascular glaucoma (NVG)
recurrent retinal detachment
recurrent retinal detachment
postoperative fibrovascular proliferation progression
postoperative fibrovascular proliferation progression

Full Information

First Posted
June 7, 2022
Last Updated
June 7, 2022
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05414149
Brief Title
Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy
Official Title
Efficacy and Safety Comparison of Ranibizumab and Conbercept Pretreatment Before Vitrectomy in Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital

4. Oversight

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

5. Study Description

Brief Summary
Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).Although pars plana vitrectomy (PPV) is the cornerstone for treatment of advanced PDR, related postoperative complications such as recurrent VH, NVG, and postoperative fibrovascular proliferation progression may still cause serious visual impairment. Preoperative intravitreal injections of anti-VEGF drugs may represent a new strategy for making vitrectomy safer and more effective for severe PDR.
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 postoperative fibrovascular proliferation progression 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.preoperative intravitreal injections of anti-VEGF drugs may represent a new strategy for making vitrectomy safer and more effective for severe PDR.Until now, there are two kinds of anti-VEGF drugs in China, including monoclonal antibodies, like imported drug Ranibizumab, militating by block VEGF-A, and fusion proteins, like domectic drug Conbercept, competitively inhibiting the binding of VEGF with its receptor by blocking multiple targets, VEGF-A, VEGF-B, and placental insulin-like growth factor (PlGF). Studies focusing on the comparison of efficacy between preoperative intravitreal injections of the two drugs for patients with severe PDR undergoing vitrectomy is still limited. Thus, in this study, we aim to carry out a more comprehensive comparison in intraoperative and postoperative aspects on the efficacy and safety between intravitreal ranibizumab injection (IVR) and intravitreal conbercept injection (IVC) before vitrectomy of PDR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Proliferative diabetic retinopathy; ranibizumab; conbercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVR group
Arm Type
Active Comparator
Arm Description
Patients that received intravitreal ranibizumab injections (IVR) (0.5mg/0.05ml) before vitreous surgery were assigned to IVR group 3-5 days before three-port transconjunctival 25-G pars plana vitrectomy (PPV). All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge Constellation system (Alcon, Fort Worth, TX, USA) system under local or anesthesia. A speed of 5000 cuts per minute was used for vitrectomy.
Arm Title
IVC group
Arm Type
Experimental
Arm Description
Patients that received intravitreal conbercept injection (IVC) (0.5mg/0.05ml) before vitreous surgery were assigned to IVC group 3-5 days before three-port transconjunctival 25-G pars plana vitrectomy (PPV). All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge Constellation system (Alcon, Fort Worth, TX, USA) system under local or anesthesia. A speed of 5000 cuts per minute was used for vitrectomy.
Intervention Type
Procedure
Intervention Name(s)
preoperative intravitreal injections of ranibizumab or conbercept
Intervention Description
IVR group means patients received intravitreal ranibizumab injections (IVR) (0.5mg/0.05ml) before vitreous surgery. IVC group means patients that received intravitreal conbercept injection (IVC) (0.5mg/0.05ml) before vitreous surgery.
Primary Outcome Measure Information:
Title
BCVA
Description
best-corrected visual acuity
Time Frame
from preoperation to 3 months follow-up
Title
CRT
Description
central retinal thickness
Time Frame
from preoperation to 3 months follow-up
Secondary Outcome Measure Information:
Title
surgery time
Description
surgery time
Time Frame
during surgery
Title
intraoperative bleeding
Description
intraoperative bleeding
Time Frame
during surgery
Title
intraocular electrocoagulation use
Description
intraocular electrocoagulation use
Time Frame
during surgery
Title
incidence of iatrogenic retinal breaks
Description
incidence of iatrogenic retinal breaks
Time Frame
during surgery
Title
relaxing retinotomy
Description
relaxing retinotomy
Time Frame
during surgery
Title
retinal reattachment
Description
retinal reattachment
Time Frame
during surgery
Title
silicone oil tamponade
Description
silicone oil tamponade
Time Frame
during surgery
Title
postoperative vitreous hemorrhage (VH)
Description
postoperative vitreous hemorrhage (VH)
Time Frame
during 3 months follow-up
Title
neovascular glaucoma (NVG)
Description
neovascular glaucoma (NVG)
Time Frame
during 3 months follow-up
Title
recurrent retinal detachment
Description
recurrent retinal detachment
Time Frame
during 3 months follow-up
Title
postoperative fibrovascular proliferation progression
Description
postoperative fibrovascular proliferation progression
Time Frame
during 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with diabetic retinopathy (DR); hemoglobin A1c (HbA1c) ≤ 12%; persistent VH for more than 1 month or recurrent vitreous hemorrhage (VH) with or without panretinal photocoagulation (PRP); TRD detected by indirect ophthalmoscope or B-scan ultrasonography. Exclusion Criteria: previous vitreoretinal surgeries (including vitrectomy, intravitreal drug 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; 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 like ranibizumab injection again or supplementary retinal photocoagulation during follow-up periods.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinfeng Qu, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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20335585
Citation
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Results Reference
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PubMed Identifier
20168268
Citation
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Results Reference
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PubMed Identifier
23807371
Citation
Bressler SB, Qin H, Melia M, Bressler NM, Beck RW, Chan CK, Grover S, Miller DG; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol. 2013 Aug;131(8):1033-40. doi: 10.1001/jamaophthalmol.2013.4154.
Results Reference
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PubMed Identifier
20222885
Citation
Ehrlich R, Harris A, Ciulla TA, Kheradiya N, Winston DM, Wirostko B. Diabetic macular oedema: physical, physiological and molecular factors contribute to this pathological process. Acta Ophthalmol. 2010 May;88(3):279-91. doi: 10.1111/j.1755-3768.2008.01501.x. Epub 2010 Mar 11.
Results Reference
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PubMed Identifier
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Citation
Wang X, Wang G, Wang Y. Intravitreous vascular endothelial growth factor and hypoxia-inducible factor 1a in patients with proliferative diabetic retinopathy. Am J Ophthalmol. 2009 Dec;148(6):883-9. doi: 10.1016/j.ajo.2009.07.007. Epub 2009 Oct 17.
Results Reference
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PubMed Identifier
27034822
Citation
Yang X, Xu J, Wang R, Mei Y, Lei H, Liu J, Zhang T, Zhao H. A Randomized Controlled Trial of Conbercept Pretreatment before Vitrectomy in Proliferative Diabetic Retinopathy. J Ophthalmol. 2016;2016:2473234. doi: 10.1155/2016/2473234. Epub 2016 Mar 13.
Results Reference
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PubMed Identifier
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Citation
Cui J, Chen H, Lu H, Dong F, Wei D, Jiao Y, Charles S, Gu W, Wang L. Efficacy and Safety of Intravitreal Conbercept, Ranibizumab, and Triamcinolone on 23-Gauge Vitrectomy for Patients with Proliferative Diabetic Retinopathy. J Ophthalmol. 2018 Jun 25;2018:4927259. doi: 10.1155/2018/4927259. eCollection 2018.
Results Reference
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Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy

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