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

NCT ID: NCT05414149

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-05-31

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.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

preoperative intravitreal injections of ranibizumab or conbercept

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

preoperative intravitreal injections of ranibizumab or conbercept

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinfeng Qu, MD

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.

Reference Type: BACKGROUND

PMID: 20335585 (View on PubMed)

Tseng VL, Greenberg PB, Scott IU, Anderson KL. Compliance with the American Academy of Ophthalmology Preferred Practice Pattern for Diabetic Retinopathy in a resident ophthalmology clinic. Retina. 2010 May;30(5):787-94. doi: 10.1097/IAE.0b013e3181cd47a2.

Reference Type: BACKGROUND

PMID: 20168268 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23807371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20222885 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19837381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27034822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30046459 (View on PubMed)

Li S, Guo L, Zhou P, Tang J, Wang Z, Zhang L, Zhao M, Qu J. Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial. Eye Vis (Lond). 2022 Dec 1;9(1):44. doi: 10.1186/s40662-022-00316-z.

Reference Type: DERIVED

PMID: 36451252 (View on PubMed)

Other Identifiers

PKUPHophthalmol

Identifier Type: -

Identifier Source: org_study_id