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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVR group | Active Comparator | 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. |
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| IVC group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative intravitreal injections of ranibizumab or conbercept | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | best-corrected visual acuity | from preoperation to 3 months follow-up |
| CRT | central retinal thickness | from preoperation to 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| surgery time | surgery time | during surgery |
| intraoperative bleeding | intraoperative bleeding | during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinfeng Qu, MD | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20335585 | Background | 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. | |
| 20168268 |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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| intraocular electrocoagulation use | intraocular electrocoagulation use | during surgery |
| incidence of iatrogenic retinal breaks | incidence of iatrogenic retinal breaks | during surgery |
| relaxing retinotomy | relaxing retinotomy | during surgery |
| retinal reattachment | retinal reattachment | during surgery |
| silicone oil tamponade | silicone oil tamponade | during surgery |
| postoperative vitreous hemorrhage (VH) | postoperative vitreous hemorrhage (VH) | during 3 months follow-up |
| neovascular glaucoma (NVG) | neovascular glaucoma (NVG) | during 3 months follow-up |
| recurrent retinal detachment | recurrent retinal detachment | during 3 months follow-up |
| postoperative fibrovascular proliferation progression | postoperative fibrovascular proliferation progression | during 3 months follow-up |
| 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. |
| 23807371 | Background | 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. |
| 20222885 | Background | 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. |
| 19837381 | Background | 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. |
| 27034822 | Background | 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. |
| 30046459 | Background | 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. |
| 36451252 | Derived | 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. |