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

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: NCT05414149
Recruitment Status : Completed
First Posted : June 10, 2022
Last Update Posted : June 10, 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).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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Procedure: preoperative intravitreal injections of ranibizumab or conbercept 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Ranibizumab and Conbercept Pretreatment Before Vitrectomy in Proliferative Diabetic Retinopathy
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: IVR group
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.
Procedure: preoperative intravitreal injections of ranibizumab or conbercept
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.

Experimental: IVC group
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.
Procedure: preoperative intravitreal injections of ranibizumab or conbercept
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 Measures :
  1. BCVA [ Time Frame: from preoperation to 3 months follow-up ]
    best-corrected visual acuity

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


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

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

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

  4. incidence of iatrogenic retinal breaks [ Time Frame: during surgery ]
    incidence of iatrogenic retinal breaks

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

  6. retinal reattachment [ Time Frame: during surgery ]
    retinal reattachment

  7. silicone oil tamponade [ Time Frame: during surgery ]
    silicone oil tamponade

  8. postoperative vitreous hemorrhage (VH) [ Time Frame: during 3 months follow-up ]
    postoperative vitreous hemorrhage (VH)

  9. neovascular glaucoma (NVG) [ Time Frame: during 3 months follow-up ]
    neovascular glaucoma (NVG)

  10. recurrent retinal detachment [ Time Frame: during 3 months follow-up ]
    recurrent retinal detachment

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



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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 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.

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): NCT05414149


Locations
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China, Beijing
Peking University People's Hospital
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:

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05414149    
Other Study ID Numbers: PKUPHophthalmol
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: June 10, 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:
Proliferative diabetic retinopathy; ranibizumab; conbercept
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
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents