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Development of intraocular sustained release system for antibodies by gas-filled hollow device

Research Project

Project/Area Number 19K09954
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 56060:Ophthalmology-related
Research InstitutionNagoya City University

Principal Investigator

Yasukawa Tsutomu  名古屋市立大学, 医薬学総合研究院(医学), 教授 (00324632)

Co-Investigator(Kenkyū-buntansha) 平野 佳男  名古屋市立大学, 医薬学総合研究院(医学), 准教授 (40405163)
加藤 亜紀  名古屋市立大学, 医薬学総合研究院(医学), 講師 (60405157)
小椋 祐一郎  名古屋市立大学, 医薬学総合研究院(医学), 教授 (70191963)
Project Period (FY) 2019-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2021)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2021: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2020: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2019: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywords加齢黄斑変性 / 抗VEGF療法 / ドラッグデリバリーシステム / 抗体医薬 / 眼科学 / 網膜
Outline of Research at the Start

滲出型加齢黄斑変性に対し抗体医薬などによる血管内皮増殖因子阻害療法により予後が改善したが、しばしば頻回投与を必要とし、経済的、身体的、精神的負担がある。
我々は網膜剥離の手術において気体の水溶性に依存して徐々に吸収、自然消失する現象にアイデアを得て、ガス封入中空デバイスによる抗体医薬徐放が可能か、長期に眼内の薬効を保つことができるかを、動物実験により検証する。
本研究により、ガス封入中空デバイスによる抗体医薬の1年以上の徐放効果の確認を行い、徐放を規定する因子(ガスの種類、デバイス内腔の形状)について評価する。また、動物モデルを用いて長期徐放による薬効を検証する。

Outline of Final Research Achievements

Intravitreal injections of anti-vascular growth factor drugs, the standard treatment for age-related macular degeneration and other macular diseases, often last for several years, making it difficult for the elderly to continue treatment. As a drug delivery system (DDS) to solve this problem, we are developing a new DDS formulation in which a hollow-core device is filled with lyophilized drug and expansile gas. An acrylic glaucoma implant-type device was implanted in a pigmented rabbit eye, and the released portion was retained intraocularly, showing sustained antibody release over six months. Next, we are developing a encircling buckling-type device used in retinal detachment surgery, because larger inner volume is available for DDS. Teflon was hard and silicone had high gas permeability. Other material will be sought.

Academic Significance and Societal Importance of the Research Achievements

加齢黄斑変性(AMD)や糖尿病黄斑浮腫は我が国における視覚障害の主要原因で、標準治療の血管内皮増殖因子(VEGF)阻害療法で、多くの症例で、視力改善とその後、数年に渡って視力維持が可能となったが、しばしば頻回の硝子体内注射の継続を必要とし、高額な薬価の問題に加え、高齢者を対象としているため、低頻度であっても脳梗塞など全身への影響、他の病気や認知症などで通院や治療の継続が困難となるなどの問題が浮き彫りになってきている。ドラッグデリバリーシステム(DDS)により薬物徐放できれば、治療効果の長期維持と副作用の軽減、患者コンプライアンスの向上、医療費削減が期待できる。

Report

(4 results)
  • 2021 Annual Research Report   Final Research Report ( PDF )
  • 2020 Research-status Report
  • 2019 Research-status Report
  • Research Products

    (13 results)

All 2022 2020 2019

All Journal Article (9 results) (of which Peer Reviewed: 9 results,  Open Access: 6 results) Presentation (4 results) (of which Int'l Joint Research: 4 results,  Invited: 1 results)

  • [Journal Article] Progression of age-related macular degeneration in eyes with abnormal fundus autofluorescence in a Japanese population: JFAM study report 32022

    • Author(s)
      Oshima Yuji、Shinojima Ari、Sawa Miki、Mori Ryusaburo、Sekiryu Tetsuju、Kato Aki、Hara Chikako、Saito Masaaki、Sugano Yukinori、Hirano Yoshio、Asato Hitomi、Nakamura Mayumi、Kimura Erika、Yuzawa Mitsuko、Ishibashi Tatsuro、Ogura Yuichiro、Iida Tomohiro、Gomi Fumi、Yasukawa Tsutomu
    • Journal Title

      PLOS ONE

      Volume: 17 Issue: 2 Pages: e0264703-e0264703

    • DOI

      10.1371/journal.pone.0264703

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Mental Status and Feasibility of an Intravitreal Ranibizumab Treat-and-Extend Regimen in Patients with Neovascular Age-Related Macular Degeneration2022

    • Author(s)
      Kato Aki、Yasukawa Tsutomu、Sugita Iichiro、Yoshida Munenori、Nozaki Miho、Hirano Yoshio、Kondo Junko、Abe Tomohiro、Sugita Kimiko、Okita Takahide、Morita Hiroshi、Takase Noriaki、Ogura Yuichiro
    • Journal Title

      Advances in Therapy

      Volume: 39 Issue: 3 Pages: 1403-1416

    • DOI

      10.1007/s12325-022-02052-1

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR : A randomized controlled trial.2020

    • Author(s)
      Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y; ALTAIR Investigators.
    • Journal Title

      Adv Ther

      Volume: 37 Issue: 3 Pages: 1173-1187

    • DOI

      10.1007/s12325-020-01236-x

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Ten-year changes in visual acuity at baseline and at 2 years after treatment in a Japanese population with age-related macular degeneration2020

    • Author(s)
      Sawada T, Yasukawa T, Imaizumi H, Matsubara H, Kimura K, Terasaki H, Ishikawa H, Murakami T, Takeuchi M, Mitamura Y, Yamashita M, Takamura Y, Murata T, Kogo J, Ohji M; J-CREST (Japan Clinical Retinal Study Team) Study Group, Japan.
    • Journal Title

      Graefes Arch Clin Exp Ophthalmol

      Volume: 258 Issue: 5 Pages: 1191-1198

    • DOI

      10.1007/s00417-020-05005-y

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Incidence of endophthalmitis after intravitreal injection of an anti-VEGF agent with or without topical antibiotics2020

    • Author(s)
      Morioka M, Takamura Y, Nagai K, Yoshida S, Mori J, Takeuchi M, Sawada T, Sone K, Fukuyama H, Kusuhara S, Yasukawa T, Murakami T, Tabuchi H, Nagasato D, Hirano T, Ueda T, Jujo T, Sasajima H, Mitamura Y, Ishikawa K, Inatani M.
    • Journal Title

      Sci Rep

      Volume: 10 Issue: 1 Pages: 22122-22122

    • DOI

      10.1038/s41598-020-79377-w

    • NAID

      120007193756

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Five-year follow-up of fundus autofluorescence and retinal sensitivity in the fellow eye in exudative age-related macular degeneration in Japan2020

    • Author(s)
      Shinojima Ari、Sawa Miki、Mori Ryusaburo、Sekiryu Tetsuju、Oshima Yuji、Kato Aki、Hara Chikako、Saito Masaaki、Sugano Yukinori、Ashikari Masayuki、Hirano Yoshio、et al.
    • Journal Title

      PLOS ONE

      Volume: 15 Issue: 3 Pages: e0229694-e0229694

    • DOI

      10.1371/journal.pone.0229694

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Dietary Saturated Fatty Acid Intake and Early Age-Related Macular Degeneration in a Japanese Population2020

    • Author(s)
      Sasaki M, Harada S, Tsubota K, Yasukawa T, Takebayashi T, Nishiwaki Y, Kawasaki R
    • Journal Title

      Invest Ophthalmol Vis Sci.

      Volume: 61 Issue: 3 Pages: 23-23

    • DOI

      10.1167/iovs.61.3.23

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Bilateral giant retinal pigment epithelial tears in hypertensive choroidopathy.2020

    • Author(s)
      5. Matsubara N, Kato A, Kominami A, Nozaki M, Yasukawa T, Yoshida M, Ogura Y.
    • Journal Title

      Am J Ophthalmol Case Rep

      Volume: 15 Pages: 100525-100525

    • DOI

      10.1016/j.ajoc.2019.100525

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Macular hole and serous pigment epithelial detachment in bilateral acquired vitelliform lesions2020

    • Author(s)
      Yata Nana、Yasukawa Tsutomu、Kawamura Mihoko、Hirano Yoshio、Ogura Yuichiro
    • Journal Title

      American Journal of Ophthalmology Case Reports

      Volume: 18 Pages: 100628-100628

    • DOI

      10.1016/j.ajoc.2020.100628

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] Intravitreal ranibizumab treat-and-extend regimen and psychological status of patients with neovascular AMD2019

    • Author(s)
      Satoshi Kuwayama, Aki Kato, Tsutomu Yasukawa, Iichiro Sugita, Munenori Yoshida, Miho Nozaki, Yoshio Hirano, Junko Kondo, Tomohiro Abe, Kimiko Sugita, Takahide Okita, Hiroshi Morita, Kazuhiko Sugitani, Naomi Inoue, Noriaki Takase, Yuichiro Ogura
    • Organizer
      ARVO 2019
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] Combination therapy with intravitreal tissue plasminogen activator and ranibizumab for wet age-related macular degeneration with subretinal hyperreflective material2019

    • Author(s)
      Ryoko Takeuchi, Tsutomu Yasukawa, Aki Kato, Tomohiro Obayashi, Satoshi Kuwayama, Soichiro Kuwayama, Norihiro Suzuki, Noriaki Takase, Naomi Inoue, Kazuhiko Sugitani, Yoshio Hirano, Munenori Yoshida, Yuichiro Ogura
    • Organizer
      ARVO 2019
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] Impacts of cataract surgery in eyes treated by anti-vascular endothelial growth factor therapy for wet age-related macular degeneration on visual outcomes2019

    • Author(s)
      Tomohiro Obayashi, Tsutomu Yasukawa, Ryoko Takeuchi, Miho Inagaki, Katsuya Suzuki, Noriaki Takase, Naomi Inoue, Aki Kato, Hiroshi Morita, Yoshio Hirano, Miho Nozaki, Munenori Yoshida, Yuichiro Ogura
    • Organizer
      ARVO 2019
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] Tsutomu Yasukawa2019

    • Author(s)
      AI-assisted detection and monitoring for macular diseases
    • Organizer
      EURETINA 2019
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research / Invited

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Published: 2019-04-18   Modified: 2023-01-30  

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