Dataset Information

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration.

ABSTRACT:

Aim

To evaluate the efficacy and safety of HLX04-O, an investigational ophthalmic formulation of HLX04 (bevacizumab biosimilar) for intravitreal injection, as a treatment for wet age-related macular degeneration (wAMD) in a phase 1/2 clinical trial (NCT04993352).

Methods

Eligible patients with wAMD were enrolled to receive HLX04-O intravitreal injections at a dose of 1.25 mg/0.05 mL every four weeks. Efficacy and adverse events were evaluated every month during study visits.

Results

A 76-year-old male with wAMD in his left eye participated in the trial and completed six cycles of HLX04-O intravitreal injections. Changes were observed in macular center point thickness (baseline vs last study visit, 437 vs 255 µm) and best-corrected visual acuity letter score (baseline vs last study visit, 36 vs 77) of the affected eye, which indicated an improvement in wAMD over treatment. No adverse events were reported by the data cutoff date.

Conclusion

HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient, demonstrating promising safety and efficacy in wAMD treatment. Large-scale studies are required to confirm the outcomes.

SUBMITTER: Zhang Z

PROVIDER: S-EPMC9453407 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration.

Zhang Zhen Z Wu Ying Y Lyu Ya-Li YL Chang Meng-Qi MQ Xu Qiu-Jin QJ Liu Yi-Ming YM Kang Wen-Ying WY Wang Qing-Yu QY Li Chuan-Ling CL

International journal of ophthalmology 20220918 9

<h4>Aim</h4>To evaluate the efficacy and safety of HLX04-O, an investigational ophthalmic formulation of HLX04 (bevacizumab biosimilar) for intravitreal injection, as a treatment for wet age-related macular degeneration (wAMD) in a phase 1/2 clinical trial (NCT04993352).<h4>Methods</h4>Eligible patients with wAMD were enrolled to receive HLX04-O intravitreal injections at a dose of 1.25 mg/0.05 mL every four weeks. Efficacy and adverse events were evaluated every month during study visits.<h4>Re ...[more]

PMID: 36124180

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Project description:BackgroundSeveral studies have investigated the efficacy and safety of Conbercept versus Triamcinolone acetonide for the treatment of wet age-related macular degeneration (wAMD), but the results are controversial. Therefore, this meta-analysis aims to evaluate the efficacy and safety of Conbercept versus Triamcinolone acetonide for the treatment of wAMD.MethodsA total of seven databases were searched for literature on the treatment of wAMD with Conbercept, with the search period from database inception to May 2024. Patients in the experimental group received Conbercept treatment, while patients in the control group received Triamcinolone acetonide treatment. The observed indicators included central macular thickness, incidence of adverse reactions, clinical efficacy, and best-corrected visual acuity. Relative risk (RR) and mean difference (MD) were used as effect measures.ResultsA total of 12 studies with 864 patients were included in the meta-analysis. The results showed that the experimental group had a significantly better central macular thickness (MD = - 42.68, 95% CI = - 55.04 ~ - 30.32, P < 0.001), clinical response rate (RR = 1.25, 95% CI = 1.12 ~ 1.39, P < 0.001), and best-corrected visual acuity (MD = 0.16, 95% CI = 0.12 ~ 0.20, P < 0.001) compared to the control group. In terms of adverse events, the overall incidence of adverse events was lower in the experimental group (RR = 0.26, 95% CI = 0.14 ~ 0.51, P < 0.001) compared to the control group. Specifically, the incidence of intraocular pressure elevation (RR = 0.33, 95% CI = 0.12 ~ 0.94, P = 0.04) and intraocular inflammation (RR = 0.17, 95% CI = 0.03 ~ 0.97, P = 0.05) was lower in the experimental group compared to the control group, but there was no significant difference in the incidence of subconjunctival hemorrhage (RR = 0.7, 95% CI = 0.14 ~ 3.5, P = 0.66) and corneal edema (RR = 0.2, 95% CI = 0.04 ~ 1.12, P = 0.07).ConclusionConbercept demonstrated superior efficacy in treating wAMD compared to triamcinolone acetonide, with a lower incidence of adverse reactions. However, the current meta-analysis included a limited number of studies, with only two studies evaluating best-corrected visual acuity (BCVA). Further high-quality randomized controlled trials (RCTs) are warranted to validate these findings.

Dataset Information

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration.

Aim

Methods

Results

Conclusion

Publications

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration.

Similar Datasets

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