Dataset Information

Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial.

ABSTRACT:

Background

To compare the efficacy and safety of preoperative intravitreal injections of ranibizumab and conbercept in Chinese proliferative diabetic retinopathy (PDR) patients.

Methods

This prospective randomized controlled trial enrolled 90 eyes of 80 patients with PDR. Forty-four eyes of 40 patients that received intravitreal ranibizumab (IVR) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVR group. Forty-six eyes of 40 patients that received intravitreal conbercept (IVC) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVC group. Intraoperative and postoperative indices were assessed for further comparison between the two groups.

Results

There were no statistically significant differences in all surgery indices, including intraoperative indices (surgery time, P = 0.225; intraoperative bleeding, P = 0.808; endodiathermy use, P = 0.693; incidence of iatrogenic retinal breaks, P = 0.740; relaxing retinotomy, P = 0.682; retinal reattachment, P = 0.682 and silicone oil tamponade, P = 0.814) and postoperative indices (postoperative vitreous hemorrhage (VH), P = 0.808; neovascular glaucoma (NVG), P = 0.964; recurrent retinal detachment, P = 0.531; postoperative fibrovascular proliferation progression, P = 0.682 and reoperation, P = 0.955) between the two groups. There were no statistically significant differences in best-corrected visual acuity (BCVA) at each follow-up visit (P = 0.939, 0.669, 0.741 and 0.717, respectively) or in central retinal thickness (CRT) (P = 0.976, 0.699, 0.551 and 0.686, respectively). As for safety profile, both groups had no ocular or system adverse events during the observation period.

Conclusions

IVR and IVC as a pretreatment of vitrectomy had similar efficacy and safety profile for Chinese PDR patients.

Trial registration

Registered at ClinicalTrials.gov ( NCT05414149 ).

SUBMITTER: Li S

PROVIDER: S-EPMC9714121 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial.

Li Siying S Guo Lili L Zhou Pingping P Tang Jiyang J Wang Zongyi Z Zhang Linqi L Zhao Mingwei M Qu Jinfeng J

Eye and vision (London, England) 20221201 1

<h4>Background</h4>To compare the efficacy and safety of preoperative intravitreal injections of ranibizumab and conbercept in Chinese proliferative diabetic retinopathy (PDR) patients.<h4>Methods</h4>This prospective randomized controlled trial enrolled 90 eyes of 80 patients with PDR. Forty-four eyes of 40 patients that received intravitreal ranibizumab (IVR) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVR group. Forty-six eyes of 40 patients that received intrav ...[more]

PMID: 36451252

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Project description:PurposeIntravitreal Conbercept (IVC) has been shown to be effective in treating proliferative diabetic retinopathy (PDR) as an adjuvant in pars plana vitrectomy (PPV); however, the best timing of IVC injection remains unknown. This network meta-analysis (NMA) sought to ascertain the comparative efficacy of different timings of IVC injection as an adjuvant to PPV on PDR.MethodsA comprehensive literature search was conducted in PubMed, EMBASE, and the Cochrane Library to identify relevant studies published before August 11, 2022. According to the mean time of IVC injection before PPV, the strategy was defined as very long interval if it was > 7 days but ≤ 9 days, long interval if it was > 5 days but ≤ 7 days, mid interval if it was > 3 days but ≤ 5 days, and short interval if it was ≤ 3 days, respectively. The strategy was defined as perioperative IVC if IVC was injected both before and at the end of PPV, and the strategy was intraoperative IVC if injected immediately at the end of PPV. The mean difference (MD) and odds ratio (OR) with corresponding 95% confidence interval (CI) for continuous and binary variables, respectively, were computed through network meta-analysis using Stata 14.0 MP.ResultsEighteen studies involving 1149 patients were included. There was no statistical difference between intraoperative IVC and control in treating PDR. Except for a very long interval, preoperative IVC significantly shortened operation time, and reduced intraoperative bleeding and iatrogenic retinal breaks. Long and short intervals reduced endodiathermy application, and mid and short intervals reduced postoperative vitreous hemorrhage. Moreover, long and mid intervals improved BCVA and central macular thickness. However, very long interval was associated with an increased risk of postoperative vitreous hemorrhage (RR: 3.27, 95%CI: 1.84 to 5.83). Moreover, mid interval was better than intraoperative IVC in shortening operation time (MD: -19.74, 95%CI: -33.31 to -6.17).ConclusionsThere are no discernible effects of intraoperative IVC on PDR, but preoperative IVC, except for very long interval, is an effective adjuvant to PPV for treating PDR.

Project description:IntroductionTo compare the efficacy and safety of intravitreal injections of ranibizumab (IVR) before and at the end of vitrectomy in proliferative diabetic retinopathy (PDR) patients.MethodsA prospective comparative study was performed on 60 eyes of 52 PDR patients who received ranibizumab injection (0.5 mg/0.05 ml) 3-5 days before vitrectomy (preoperative group) and 55 eyes of 50 PDR patients who received ranibizumab injection (0.5 mg/0.05 ml) at the end of vitrectomy (intraoperative group). Intra- and postoperative indices were collected for further comparison.ResultsPostoperative best-corrected visual acuity (BCVA) in preoperative group was better than in intraoperative group at 1 week after surgery (P < 0.05) but comparable at 1- and 3-month follow-up (P = 0.20 and P = 0.37, respectively). Central retinal thickness (CRT) in preoperative group was lower than in intraoperative group at 1 week postoperatively (P < 0.05), but comparable at 1- and 3-month follow-up (P = 0.39 and P = 0.77, respectively). The average surgery time was significantly shorter in preoperative group than in intraoperative group (61.50 ± 11.44 min vs. 74.49 ± 12.01 min, P < 0.01). The incidence of intraoperative bleeding was significant lower in preoperative group than in intraoperative group (21.7% vs. 40.0%, P < 0.05). Moreover, the incidence of intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade were all significantly lower in preoperative group than that in intraoperative group (P < 0.05, respectively). The incidences of postoperative vitreous hemorrhage (VH), neovascular glaucoma (NVG), recurrent retinal detachment, postoperative fibrovascular proliferation progression and reoperation showed no statistical differences between the two groups (P > 0.05, respectively). Both groups had no ocular or system adverse events during observation period.ConclusionIn vitrectomy for PDR, preoperative IVR can significantly reduce surgery time and lower the incidence of intraoperative bleeding, intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade during surgery and gain short-term better postoperative BCVA and thinner CRT.Trial registrationClinicalTrials.gov (identifier, NCT05408416).

Project description:BackgroundDiabetic retinopathy is a leading cause of visual loss in the working population. Pars plana vitrectomy has become the mainstream treatment option for severe proliferative diabetic retinopathy (PDR) associated with significant vitreous haemorrhage and/or tractional retinal detachment. Despite the advances in surgical equipment, diabetic vitrectomy remains a challenging operation, requiring advanced microsurgical skills, especially in the presence of tractional retinal detachment. Preoperative intravitreal bevacizumab has been widely employed as an adjuvant to ease surgical difficulty and improve postoperative prognosis.Aims: This study aims to assess the effectiveness of preoperative intravitreal bevacizumab in reducing intraoperative complications and improving postoperative outcomes in patients undergoing vitrectomy for the complications of PDR.MethodsA literature search was conducted using the PubMed, Cochrane, and ClinicalTrials.gov databases to identify all related studies published before 31/10/2020. Prespecified outcome measures were operation time, intraoperative iatrogenic retinal breaks, best-corrected visual acuity in the last follow-up visit, the presence of any postoperative vitreous haemorrhage and the need to re-operate. Evidence synthesis was performed using Fixed or Random Effects models, depending on the heterogeneity of the included studies. Heterogeneity was assessed using Q-statistic and I2. Additional meta-regression models, subgroup analyses and sensitivity analyses were performed as appropriate.ResultsThirteen randomized control trials, with a total of 688 eyes were included in this review. Comparison of the intraoperative data showed that bevacizumab reduced operation time (p < 0.001), minimized iatrogenic retinal breaks (p < 0.001), provided better long-term visual acuity outcomes (p = 0.005), and prevented vitreous haemorrhage (p < 0.001) and the need for reoperation (p = 0.001 < 0.05). Findings were strongly corroborated by additional sensitivity and subgroup analyses.ConclusionPreoperative administration of bevacizumab is effective in reducing intraoperative complications and improving the postoperative prognosis of diabetic vitrectomy.PROSPERO registration number: CRD42021219280.

Project description:ImportanceVascular endothelial growth factor plays a role in proliferative diabetic retinopathy (PDR). Intravitreal injection of saline has been shown potentially to lead to improved visual acuity compared with observation alone in eyes with vitreous hemorrhage. Therefore, it is important to determine if intravitreal anti-vascular endothelial growth factor can reduce vitrectomy rates (and risks associated with vitrectomy) compared with saline for vitreous hemorrhage from PDR that precludes placement or confirmation of complete panretinal photocoagulation.ObjectiveTo evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage from PDR.DesignPhase 3, double-masked, randomized, multicenter clinical trial. Data reported were collected from June 2010 to March 2012 and include 16 weeks of follow-up.SettingCommunity-based and academic-based ophthalmology practices specializing in retinal diseases.ParticipantsTwo hundred sixty-one eyes of 261 study participants, who were at least 18 years of age with type 1 or type 2 diabetes mellitus. Study eyes had vitreous hemorrhage from PDR precluding panretinal photocoagulation completion.InterventionEyes were randomly assigned to 0.5-mg intravitreal ranibizumab (n = 125) or intravitreal saline (n = 136) at baseline and 4 and 8 weeks.Main outcome measureCumulative probability of vitrectomy within 16 weeks.ResultsCumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab vs 17% with saline (difference, 4%; 95% CI, -4% to 13%) and of complete panretinal photocoagulation without vitrectomy by 16 weeks was 44% and 31%, respectively (P = .05). The mean (SD) visual acuity improvement from baseline to 12 weeks was 22 (23) letters and 16 (31) letters, respectively (P = .04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17%, respectively (P = .01). One eye developed endophthalmitis after saline injection.Conclusions and relevanceOverall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR. Short-term secondary outcomes including visual acuity improvement, increased panretinal photocoagulation completion rates, and reduced recurrent vitreous hemorrhage rates suggest biologic activity of ranibizumab. Long-term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab injection are different than observation alone cannot be determined from this study.Trial registrationThe study is listed on www.clinicaltrials.gov, under identifier NCT00996437 (website registration date October 14, 2009).

Dataset Information

Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial.

Similar Datasets

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