生物类似药与近视CNVM中的创新药拉尼兹巴:比较现实世界结果-BRIM研究
Debdulal Chakraborty1, Tushar Kanti Sinha1, Sourav Sinha2
1Vitreo-Retina Services, Disha Eye Hospitals, Kolkata, WB, India.
Clinical ophthalmology (Auckland, N.Z.)
|October 16, 2025
概括
生物类似的拉尼比祖马布 (Razumab) 与创新版本 (Lucentis) 一样有效和安全,用于治疗近视性冠状腺新血管化 (mCNVM). 这两种治疗方法在12个月内显示出视力和视网膜厚度的类似改善.
科学领域:
- 眼科医生 眼科 眼科
- 视网膜疾病 视网膜疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 近视性冠状腺新血管化 (mCNVM) 是高近视的视力丧失的主要原因.
- 静脉内抗血管内皮生长因子 (VEGF) 治疗是mCNVM的标准治疗方法.
研究的目的:
- 为了比较生物仿制拉尼比祖马布 (Razumab) 与创新者拉尼比祖马布 (Lucentis/Accentrix) 在治疗mCNVM的疗效和安全性.
- 评估拉尼比祖马布两种配方的视觉和解剖结果,以及安全概况.
主要方法:
- 从2021年1月到2023年12月,对从未接受过治疗的mCNVM患者 (n=80) 的回顾性多中心研究.
- 患者接受了创新者或生物类似物拉尼比祖马布的静脉内注射,按照预先计划 (PRN) 协议.
- 结果包括最佳校正视敏度 (BCVA),中央黄斑厚度 (CMT),眼内压力 (IOP),注射频率和至少12个月的随访期间的安全性.
主要成果:
- 这两组在12个月后都显示出显著的BCVA改善和CMT减少 (p > 0.05).
- 在创新者和生物类似组中,平均BCVA从大约51-52个ETDRS字母增加到64.5个ETDRS字母.
- 在两组中,CMT从超过315μm下降到大约270μm. 在两种拉尼比祖马布配方之间,注射频率,IOP和安全性概况是可比的.
结论:
- 生物类似的拉尼比祖马布 (Razumab) 与创新型拉尼比祖马布 (Lucentis/Accentrix) 相比,在mCNVM治疗中显示出非劣质的视觉和解剖结果.
- 生物类似药和创新型拉尼比祖马布组的安全性和治疗负担相似.
- 这些发现支持使用生物类拉尼比祖马布作为mCNVM的可行的治疗选择.
更多相关视频
06:19Comparison of Three Clinical Stereoscopic Methods for Measuring Binocular Visual Function During Amblyopic Treatment in Unilateral Amblyopia
Published on: September 27, 2024
520
09:56In Vivo Multimodal Imaging and Analysis of Mouse Laser-Induced Choroidal Neovascularization Model
Published on: January 21, 2018
9.8K
相关概念视频
Bioequivalence studies: Biowaivers
220
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
220
Angle Closure Glaucoma: Treatment
1.1K
Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...
1.1K
Open Angle Glaucoma: Treatment
958
In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Drugs such as carbonic anhydrase inhibitors, α2- and...
958
Bioequivalence: Overview
1.8K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.8K
Glaucoma: Overview
1.2K
Glaucoma is an eye condition characterized by increased intraocular pressure that damages the retina and optic nerve, leading to irreversible blindness if left untreated. The human eye has various components, including the cornea, iris, pupil, lens, and optic nerve. Aqueous humor is secreted by the epithelium of the ciliary body in the posterior chamber and flows through the trabecular meshwork and canal of Schlemm, maintaining normal intraocular pressure. The trabecular meshwork and the canal...
1.2K
