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更新于：2025-01-23
Revakinagene taroretcel
更新于：2025-01-23
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关联
15
项与 Revakinagene taroretcel 相关的临床试验NCT06397131
A Multicenter Study to Determine the Safety and Efficacy of NT-501 Utilizing the Medica Membrane in Macular Telangiectasia Type 2
NCT04729972
Phase II, Multicenter, Open-label Safety Study of Bilateral NT-501 in Participants With Macular Telangiectasia Type 2
NCT04577300
A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
100 项与 Revakinagene taroretcel 相关的临床结果
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100 项与 Revakinagene taroretcel 相关的转化医学
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100 项与 Revakinagene taroretcel 相关的专利（医药）
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6
项与 Revakinagene taroretcel 相关的文献（医药）2023-09-01Ophthalmology science
Phase I NT-501 Ciliary Neurotrophic Factor Implant Trial for Primary Open-Angle Glaucoma
Article
作者: Satterfield, Kellie R ; Lam, Byron L ; Albini, Thomas A ; Nuñez, Mariana ; Beykin, Gala ; Goldberg, Jeffrey L
Purpose:
To assess the safety and efficacy of a ciliary neurotrophic factor (CNTF) intraocular implant on neuroprotection and neuroenhancement in glaucoma.
Design:
Open-label, prospective, phase I clinical trial.
Participants:
A total of 11 participants were diagnosed with primary open-angle glaucoma (POAG). One eye of each patient was assigned as the study (implant) eye.
Methods:
The study eye was implanted with a high-dose CNTF-secreting NT-501 implant, whereas the other eye served as a control. All patients were followed up for 18 months. Analysis was limited to descriptive statistics.
Main Outcome Measures:
Primary outcome was safety through 18 months after implantation assessed by serial eye examinations, structural and functional testing, and adverse events (AEs) recording. Parameters measured included visual acuity (VA), Humphrey visual field (HVF), pattern electroretinogram, scanning laser polarimetry with variable corneal compensation (GDx VCC), and OCT. These parameters were also used for secondary analysis of efficacy outcome.
Results:
All NT-501 implants were well tolerated with no serious AEs associated with the implant. The majority of AEs were related to the implant placement procedure and were resolved by 12 weeks after surgery. Foreign-body sensation was the most commonly reported AE and was self-limited to the postoperative period. The most common implant-related AE was pupil miosis; no patients underwent explant. Visual acuity and contrast sensitivity decreased more in fellow eyes than in study eyes (VA, -5.82 vs. -0.82 letters; and contrast sensitivity, -1.82 vs. -0.37 letters, for fellow vs. study eyes, respectively). The median HVF visual field index and mean deviation measurements worsened (decreased) in fellow eyes (-13.0%, -3.9 dB) and improved (increased) in study eyes (2.7%, 1.2 dB). Implanted eyes showed an increase in retinal nerve fiber layer thickness measured by OCT and by GDx VCC (OCT, 2.66 μm vs. 10.16 μm; and GDx VCC, 1.58 μm vs. 8.36 μm in fellow vs. study eyes, respectively).
Conclusions:
The NT-501 CNTF implant was safe and well tolerated in eyes with POAG. Eyes with the implant demonstrated both structural and functional improvements suggesting biological activity, supporting the premise for a randomized phase II clinical trial of single and dual NT-501 CNTF implants in patients with POAG, which is now underway.
Financial Disclosures:
Proprietary or commercial disclosure may be found after the references.
2021-03-01Veterinary ophthalmology4区 · 农林科学
Medical anti‐glaucoma therapy: Beyond the drop
4区 · 农林科学
Review
作者: Miller, Paul E. ; Eaton, Joshua Seth
Abstract:
Barriers to effective medical therapy are numerous and include difficulties with effective and sustained control of intraocular pressure (IOP) and adherence to prescribed anti‐glaucoma drop regimens. In an effort to circumvent these challenges, a number of new anti‐glaucoma therapies with sustained effects have emerged. Methods for sustained delivery of prostaglandin analogs are being intensely investigated and many are in human clinical trials. Intracameral devices include the following: Allergan's Durysta™ Bimatoprost SR, Envisia Therapeutics’ ENV515 travoprost implant, Glaukos’ iDose™, Ocular Therapeutix's OTX‐TIC travoprost implant, and Santen's polycaprolactone implant with PGE2‐derivative DE‐117. Other prostaglandin‐based technologies include Allergan's bimatoprost ring (placed in the conjunctival fornix), Ocular Therapeutics’ OTX‐TP intracanalicular travoprost implant, subconjunctival latanoprost in a liposomal formulation, and the PGE2 derivative PGN 9856‐isopropyl ester that is applied to the periorbital skin. Exciting breakthroughs in gene therapy include using viral vectors to correct defective genes such as MYOC or to modulate gonioimplant fibrosis, CRISPR technology to edit MYOC or to alter aquaporin to reduce aqueous humor production, and siRNA technology to silence specific genes. Stem cell technology can repopulate depleted tissues or, in the case of Neurotech's Renexus® NT‐501 intravitreal implant, serve as a living drug delivery device that continuously secretes neurotrophic factors. Other unique approaches involve nanotechnology, nasal sprays that deliver drug directly to the optic nerve and noninvasive alternating current stimulation of surviving cells in the optic nerve. Over time these modalities are likely to challenge the preeminent role that drops currently play in the medical treatment of glaucoma in animals.
2021-01-01Ophthalmic research4区 · 医学
The Use of Neuroprotective Agents in Treating Geographic Atrophy
4区 · 医学
Review
作者: Scholl, Hendrik P N ; Giani, Andrea ; Chong, Victor ; Boyer, David
Geographic atrophy (GA) secondary to age-related macular degeneration accounts for close to one-quarter of cases of legal blindness in the USA and the UK. Despite this notable disease burden, the pathophysiology of GA is complex and not fully understood, and there is currently no approved treatment to prevent or slow its progression. GA is heterogeneous in its appearance and extent, and underlying associated traits such as drusen and complement factor polymorphisms vary between patients and by ethnicity, posing a challenge for treatment development. The root cause of vision loss in GA is photoreceptor death; therefore, protecting photoreceptors from damage and delaying their degeneration are key to successful GA treatment. There are multiple neuroprotective pathways that may contribute to protecting photoreceptors from damage, and compounds that target these pathways include antioxidants, neurotrophic factors, and catalases. However, the efficacy of previously trialled neuroprotective therapies in GA, such as brimonidine, tandospirone, and NT-501, has been inconsistent; this may be due to their target of action, method of delivery, and/or suboptimal duration of action. Neurotrophic factors, or molecules involved in neuroprotective signalling cascades, may be ideal agents for further investigation for the treatment of GA. Future neuroprotective strategies in GA must focus on the development of agents with a long duration of action that can combat the progression of chronic damage in GA to provide clinically meaningful benefits for patients.
11
项与 Revakinagene taroretcel 相关的新闻（医药）2025-01-06
优先审批免疫疗法生物类似药细胞疗法突破性疗法
2024-11-11
临床3期细胞疗法优先审批基因疗法快速通道
100 项与 Revakinagene taroretcel 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 2型黄斑毛细血管扩张症 | 申请上市 | 美国 | 2024-06-20 | |
| 视网膜毛细血管扩张 | 临床3期 | 澳大利亚 | 2018-01-19 | |
| 视网膜色素变性 | 临床3期 | 美国 | 2007-04-16 | |
| 色觉障碍 | 临床2期 | 美国 | 2012-07-07 | |
| 全色盲1型 | 临床2期 | 美国 | 2012-07-01 | |
| Usher综合征 | 临床2期 | 美国 | 2012-01-20 | |
| Usher综合征2型 | 临床2期 | 美国 | 2012-01-01 | |
| 黄斑变性 | 临床2期 | 美国 | 2007-01-01 | |
| 视力低下 | 临床2期 | 美国 | 2007-01-01 | |
| 地图样萎缩 | 临床2期 | 美国 | - |
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临床结果
临床结果
适应症
分期
评价
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EURETINA2024 人工标引  | N/A | - | 齋鏇蓋獵選蓋願選淵鬱(構窪獵遞築網艱蓋鏇醖) = 遞簾憲衊積窪鏇遞餘夢 積築窪齋鹹蓋網網選窪 (範襯鹹壓餘積糧構廠網 ) 更多 | 积极 | 2024-09-19 | ||
Sham | 齋鏇蓋獵選蓋願選淵鬱(構窪獵遞築網艱蓋鏇醖) = 構壓鬱壓膚選憲構鏇簾 積築窪齋鹹蓋網網選窪 (範襯鹹壓餘積糧構廠網 ) 更多 | ||||||
N/A | - | 繭選醖艱衊膚獵範醖製(觸願選網鬱壓積憲範衊) = 夢憲簾窪鏇顧蓋鏇廠鑰 淵鏇艱壓繭鏇鏇繭鹽夢 (淵窪淵築鏇選艱範製選, 0.05 ~ 0.10) | - | 2024-09-19 | |||
Sham treatment | 繭選醖艱衊膚獵範醖製(觸願選網鬱壓積憲範衊) = 範鬱鏇憲繭齋襯選遞鬱 淵鏇艱壓繭鏇鏇繭鹽夢 (淵窪淵築鏇選艱範製選, 0.14 ~ 0.19) | ||||||
N/A | - | 鏇醖顧壓廠餘鑰鑰夢壓(蓋餘膚窪醖製夢繭鹽廠) = Non-ocular SAEs were comparable between treatment groups in NTMT-03-A (NT-501, 17.2% [10/58]; sham, 10.5% [6/57]) and NTMT-03-B (NT-501, 13.6% [8/59]; sham, 18.5% [10/54]), and none were related to treatment 餘餘鏇築積網夢淵構鬱 (繭獵艱蓋膚鑰齋鹹窪願 ) 更多 | - | 2023-10-05 | |||
(Sham treatment) | |||||||
N/A | - | - | 顧構製獵構廠網願範壓(衊觸遞齋鹹鏇餘憲窪壓) = 壓艱夢淵築積鏇遞製蓋 積製糧鹽鹽齋膚糧觸鏇 (鑰積夢網窪築範廠繭鹹 ) | - | 2023-04-23 | ||
临床3期 | 115 | 製鏇夢鏇觸鬱鏇顧顧糧(廠鬱餘衊淵壓淵醖鹽淵) = 鹽製構鹽築構網簾壓糧 鬱簾製鏇廠餘齋艱範築 (憲顧淵襯齋願構選淵鑰 ) | 积极 | 2022-11-02 | |||
Sham Procedure | - | ||||||
临床3期 | - | 鬱顧網淵獵遞壓獵觸網(夢窪衊簾齋鹹齋獵鑰憲) = 膚齋醖範糧齋製獵醖鏇 願鹹網範選選鏇艱築蓋 (齋積窪願網觸觸製蓋獵, 0.19) | 积极 | 2021-03-15 | |||
untreated | 鬱顧網淵獵遞壓獵觸網(夢窪衊簾齋鹹齋獵鑰憲) = 製鬱夢齋壓繭壓鑰顧衊 願鹹網範選選鏇艱築蓋 (齋積窪願網觸觸製蓋獵, 0.11) |
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