Dataset Information

One-Year Effectiveness Study of Intravitreously Administered Conbercept^® Monotherapy in Diabetic Macular Degeneration: A Systematic Review and Meta-Analysis.

ABSTRACT:

Introduction

The evidence on efficacy of intravitreously administered Conbercept (IVC) monotherapy for diabetic macular degeneration was still limited.

Methods

A systematic review was conducted in November 2019 to summarize the current evidence on visual acuity (VA) changes with IVC monotherapy in the treatment of diabetic macular edema (DME) from Pubmed, ClinicalTrials.gov, EMbase, China National Knowledge Infrastructure (CNKI), Wanfang Database, Chin VIP Information (VIP), and Chinese Biomedical Database (CBM). Retrospective or prospective clinical studies which used IVC injection for the treatment of DME were included. Outcomes included in the analysis were change in best-corrected visual acuity (BCVA) and central macular thickness (CMT). A meta-regression was conducted to assess 1-year BCVA and CMT changes against numbers of injections.

Results

A total of 20 studies were included in current study. At 12-month follow-up, an overall increase of 0.67 logarithm of the minimum angle of resolution (logMAR) BCVA score [95% confidence interval (CI) 0.24-1.11; P = 0.003] and 1.03 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (95% CI 0.69-1.38; P < 0.001) was shown with IVC injection compared to baseline. Decrease in CMT was 142.79 μm (95% CI 112.71-172.87; P < 0.001) compared to baseline. The meta-regression showed a significant increase in effect size between number of injections and 12-month logMAR BCVA scale change as well as CMT.

Conclusion

Our findings suggest improved VA and CMT outcomes during 1-year follow-up in patients with DME who underwent IVC monotherapy. Increased injection frequency demonstrates a significant trend with improved outcomes at 12 months.

SUBMITTER: Wang H

PROVIDER: S-EPMC7192996 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: With the advent of aging society of China, fundus diseases related to pathological neovascularization, including age-related macular degeneration (AMD), diabetic macular edema (DME), and pathological myopia (PM), have become an increasingly serious medical and health problems. As effective drugs of the treatment, conbercept and ranibizumab have been commonly used and covered by the national basic medical insurance in China. However, the pharmacoeconomic evaluation of conbercept vs. ranibizumab for DME and PM remains lacking. This study would assess the cost-effectiveness of conbercept and ranibizumab for the treatment of AMD, DME, and PM from the perspective of Chinese payers. Methods: A Markov chain model was constructed based on the visual conditions of the patient indicated by the number of letters in best corrected visual acuity (BCVA). We conducted models based on real-world scenario to calculate the cost per the quality-adjusted life-year (QALY) gained. A 1-year cycle length and a 10-year simulation treatment were applied and the number of injections of conbercept and ranibizumab was assumed to the average number within 10 years. Transition probabilities, costs, utility data, and other parameters were obtained from literature searches. A 3.5% discounting rate was applied for both the costs and utilities. Results: The incremental cost-effectiveness ratios (ICERs) were more favorable for conbercept than ranibizumab in treatment of AMD, DME, and PM, with associated ICER of 66,669 renminbi (RMB), -258,813 RMB, and -373,185 RMB per QALY gained. Compared with ranibizumab, the incremental effectiveness of conbercept in treatment of AMD, DME, and PM was -0.665 QALYs, 0.215 QALYs, and 0.029 QALYs, respectively. The sensitivity analysis showed the same findings, although the ICER is sensitive to the costs of this program. Conclusion: Under the current Chinese healthcare setting, conbercept is suitable and cost-effective in treatment of AMD, DME, and PM compared with ranibizumab.

Project description:Background: Conbercept is a new anti-vascular endothelial growth factor (VEGF) drug. Here, we systematically conducted the efficacy, safety, compliance, and pharmacoeconomic evaluation of intravitreal conbercept (IVC) compared with other treatments in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or pathologic myopia choroidal neovascularization (pmCNV). Methods: Databases of PubMed, Embase, Cochrane Library, ClinicalTrials.gov, SinoMed, China National Knowledge Infrastructure, and WanFang Data were systematically searched from the inception to July 27, 2021. Randomized clinical trials and pharmacoeconomic studies comparing IVC with control groups in adults with nAMD, DME, or pmCNV were reviewed and selected. Meta-analyses were performed using the fixed-effects model when pooled data were homogeneous. Heterogeneous data were analyzed using the random-effects model. Primary outcomes included visual improvement rate, mean change in visual acuity or best corrected visual acuity, and pharmacoeconomic outcomes. Additional outcomes were the mean change in fundus examination values, adverse events (AEs), quality-of-life measures, and number of injections. Results: Among 3,591 screened articles, 22 original studies with 1,910 eyes of patients were finally included. For nAMD and DME, IVC was significantly associated with better visual acuity or best corrected visual acuity improvement and fundus quantitative measures than placebo, laser photocoagulation (LP), or intravitreal triamcinolone acetonide (IVT). However, IVC showed non-inferior efficacy to intravitreal ranibizumab (IVR) according to low quality of evidence, and there was lack of trials comparing the priority of IVC to other anti-VEGF regimens. No definitive increased risk of ocular or non-ocular AEs were observed in the study groups. All patients with AEs recovered after symptomatic treatments, and no severe AEs occurred. Patients treated with IVC might have higher quality-of-life scores than those in IVR in nAMD or LP in DME. Additionally, IVC showed cost-utility advantages in nAMD and cost-effectiveness advantages than IVR in pmCNV in China. Conclusion: IVC is well-tolerated and effective for improving vision acuity and quantitative measures in fundus condition in patients with nAMD and DME compared with LP, IVT, and placebo, but gains comparable efficacy to IVR. However, well-designed, large-sample, and long-term evaluation of IVC shall be conducted in additional studies worldwide.

Project description:BackgroundIn eyes with diabetic macular edema, the relative efficacy of administering aflibercept monotherapy as compared with bevacizumab first with a switch to aflibercept if the eye condition does not improve sufficiently (a form of step therapy) is unclear.MethodsAt 54 clinical sites, we randomly assigned eyes in adults who had diabetic macular edema involving the macular center and a visual-acuity letter score of 24 to 69 (on a scale from 0 to 100, with higher scores indicating better visual acuity; Snellen equivalent, 20/320 to 20/50) to receive either 2.0 mg of intravitreous aflibercept or 1.25 mg of intravitreous bevacizumab. The drug was administered at randomization and thereafter according to the prespecified retreatment protocol. Beginning at 12 weeks, eyes in the bevacizumab-first group were switched to aflibercept therapy if protocol-specified criteria were met. The primary outcome was the mean change in visual acuity over the 2-year trial period. Retinal central subfield thickness and visual acuity at 2 years and safety were also assessed.ResultsA total of 312 eyes (in 270 adults) underwent randomization; 158 eyes were assigned to receive aflibercept monotherapy and 154 to receive bevacizumab first. Over the 2-year period, 70% of the eyes in the bevacizumab-first group were switched to aflibercept therapy. The mean improvement in visual acuity was 15.0 letters in the aflibercept-monotherapy group and 14.0 letters in the bevacizumab-first group (adjusted difference, 0.8 letters; 95% confidence interval, -0.9 to 2.5; P = 0.37). At 2 years, the mean changes in visual acuity and retinal central subfield thickness were similar in the two groups. Serious adverse events (in 52% of the patients in the aflibercept-monotherapy group and in 36% of those in the bevacizumab-first group) and hospitalizations for adverse events (in 48% and 32%, respectively) were more common in the aflibercept-monotherapy group.ConclusionsIn this trial of treatment of moderate vision loss due to diabetic macular edema involving the center of the macula, we found no evidence of a significant difference in visual outcomes over a 2-year period between aflibercept monotherapy and treatment with bevacizumab first with a switch to aflibercept in the case of suboptimal response. (Funded by the National Institutes of Health; Protocol AC ClinicalTrials.gov number, NCT03321513.).

Dataset Information

One-Year Effectiveness Study of Intravitreously Administered Conbercept^® Monotherapy in Diabetic Macular Degeneration: A Systematic Review and Meta-Analysis.

Introduction

Methods

Results

Conclusion

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Dataset Information

One-Year Effectiveness Study of Intravitreously Administered Conbercept® Monotherapy in Diabetic Macular Degeneration: A Systematic Review and Meta-Analysis.

Introduction

Methods

Results

Conclusion

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

One-Year Effectiveness Study of Intravitreously Administered Conbercept^® Monotherapy in Diabetic Macular Degeneration: A Systematic Review and Meta-Analysis.