An Arched Micro-Injector (ARCMI) for Innocuous Subretinal Injection

You, Yong Sung; Lee, Chang Yeol; Li, Chengguo; Lee, Sung Ho; Kim, Kibom; Jung, Hyungil

doi:10.1371/journal.pone.0104145

Cited by 10 publications

(3 citation statements)

References 12 publications

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“…). Such steps may be expected if greater hydraulic forces are required in NHPs compared to humans to overcome the adhesion between the retina and the RPE, which in turn may result in uneven rates of delivery of the subretinal injections 47, 50, 51, 52, 53. In fact, efforts are underway to de-risk the subretinal injections in patients with the use of mechanical devices that deliver precise volumes at prescribed hydrostatic pressures, as well as with the use of intraoperative SD-OCT systems that allow real time view of the microscopic retinal structure during the surgical interventions 52, 54.…”

Section: Discussionmentioning

confidence: 99%

Safety of Same-Eye Subretinal Sequential Readministration of AAV2-hRPE65v2 in Non-human Primates

Weed

Ammar

Zhou

et al. 2019

Molecular Therapy - Methods & Clinical Development

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We have demonstrated safe and effective subretinal readministration of recombinant adeno-associated virus serotype (rAAV) to the contralateral eye in large animals and humans even in the setting of preexisting neutralizing antibodies (NAbs). Readministration of AAV to the same retina may be desirable in order to treat additional areas of the retina not targeted initially or to boost transgene expression levels at a later time point. To better understand the immune and structural consequences of subretinal rAAV readministration to the same eye, we administered bilateral subretinal injections of rAAV2-hRPE65v2 to three unaffected non-human primates (NHPs) and repeated the injections in those same eyes 2 months later. Ophthalmic exams and retinal imaging were performed after the first and second injections. Peripheral blood monocytes, serum, and intraocular fluids were collected at baseline and post-injection time points to characterize the cellular and humoral immune responses. Histopathologic and immunohistochemical studies were carried out on the treated retinas. Ipsilateral readministration of AAV2-hRPE65v2 in NHPs did not threaten the ocular or systemic health through the time span of the study. The repeat injections were immunologically and structurally well tolerated, even in the setting of preexisting serum NAbs. Localized structural abnormalities confined to the outer retina and retinal pigmented epithelium (RPE) after readministration of the treatment do not differ from those observed after single or contralateral administration of an AAV carrying a non-therapeutic transgene in NHPs and were not observed in a patient treated with the nearly identical, FDA-approved, AAV2-hRPE65v2 vector (voretigene neparvovec-rzyl), suggesting NHP-specific abnormalities.

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Section: Discussionmentioning

confidence: 99%

Safety of Same-Eye Subretinal Sequential Readministration of AAV2-hRPE65v2 in Non-human Primates

Weed

Ammar

Zhou

et al. 2019

Molecular Therapy - Methods & Clinical Development

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“…2a, the hollow microneedle was fabricated with an optimized structure of 60 μm inner diameter, 120 μm outer diameter, and 15°bevel angle for minimally invasive blood collection by drawing lithography technology. 21,22 Moreover, to enhance biomedical compatibility, a 1 μm thick biocompatible parylene film was deposited onto the inner and outer surface of the hollow microneedle (Fig. S1 †).…”

Section: Optimization Of the Obmsmentioning

confidence: 99%

One-touch-activated blood multidiagnostic system using a minimally invasive hollow microneedle integrated with a paper-based sensor

et al. 2015

Self Cite

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The development of real-time innocuous blood diagnosis has been a long-standing goal in healthcare; an improved, miniature, all-in-one point-of-care testing (POCT) system with low cost and simplified operation is highly desired. Here, we present a one-touch-activated blood multidiagnostic system (OBMS) involving the synergistic integration of a hollow microneedle and paper-based sensor, providing a number of unique characteristics for simplifying the design of microsystems and enhancing user performance. In this OBMS, all functions of blood collection, serum separation, and detection were sequentially automated in one single device that only required one-touch activation by finger-power without additional operations. For the first time, we successfully demonstrated the operation of this system in vivo in glucose and cholesterol diagnosis, showing a great possibility for human clinical application and commercialization. Additionally, this novel system offers a new approach for the use of microneedles and paper sensors as promising intelligent elements in future real-time healthcare monitoring devices.

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“…[13][14][15][16] An ultra-thin and tower-shaped MN was capable of direct subretinal injection with minimal ocular incisions. [17,18] The MN technology has also been actively used to treat anterior ocular diseases. A coated MN and hybrid detachable MN have been developed and successfully applied to treat corneal diseases without any side effects from micro-incisions due to MNs.…”

Section: Introductionmentioning

confidence: 99%

Self‐Plugging Microneedle (SPM) for Intravitreal Drug Delivery

Lee

Park

et al. 2022

Adv Healthcare Materials

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Intravitreal injection (IVI) is a common technology which is used to treat ophthalmic diseases inside eyeballs by delivering various drugs into the vitreous cavity using hypodermic needles. However, in some cases, there are possible side effects such as ocular tissue damage due to repeated injection or eyeball infection through the hole created during the needle retraction process. The best scenario of IVI is a one-time injection of drugs without needle retraction, keeping the system of the eyeball closed. Microneedles (MNs) have been applied to ocular tissues over 10 years, and no serious side effects on ocular tissue due to MN injection have been reported. Therefore, a self-plugging MN (SPM) is developed to perform intraocular drug delivery and to seal the scleral puncture simultaneously. The SPMs are fabricated by a thermal drawing process and then coated with a polymeric carrier of drugs and a hydrogel-based scleral plugging component. Each coated functional layer is characterized and demonstrated by in vitro and ex vivo experiments. Finally, in vivo tests using a porcine model confirms prompt sealing of SPM and sustained intraocular drug delivery.

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An Arched Micro-Injector (ARCMI) for Innocuous Subretinal Injection

Cited by 10 publications

References 12 publications

Safety of Same-Eye Subretinal Sequential Readministration of AAV2-hRPE65v2 in Non-human Primates

Safety of Same-Eye Subretinal Sequential Readministration of AAV2-hRPE65v2 in Non-human Primates

One-touch-activated blood multidiagnostic system using a minimally invasive hollow microneedle integrated with a paper-based sensor

Self‐Plugging Microneedle (SPM) for Intravitreal Drug Delivery

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