WO2016090590A1 - Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active - Google Patents

Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active Download PDF

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WO2016090590A1
WO2016090590A1 PCT/CN2014/093548 CN2014093548W WO2016090590A1 WO 2016090590 A1 WO2016090590 A1 WO 2016090590A1 CN 2014093548 W CN2014093548 W CN 2014093548W WO 2016090590 A1 WO2016090590 A1 WO 2016090590A1
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treatment
vegf
lesion
size
cnv
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PCT/CN2014/093548
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English (en)
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Oliver ZEITZ
Olaf Sowade
Haiyan Wu
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Bayer Healthcare Llc
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Priority to PCT/CN2014/093548 priority Critical patent/WO2016090590A1/fr
Priority to HRP20220066TT priority patent/HRP20220066T1/hr
Priority to EP21207057.7A priority patent/EP3985023A1/fr
Priority to HUE15819965A priority patent/HUE057653T2/hu
Priority to PCT/US2015/065022 priority patent/WO2016094673A1/fr
Priority to AU2015360496A priority patent/AU2015360496B2/en
Priority to EP15819965.3A priority patent/EP3230316B1/fr
Priority to DK15819965.3T priority patent/DK3230316T3/da
Priority to CN202210019267.XA priority patent/CN114306575A/zh
Priority to PL15819965T priority patent/PL3230316T3/pl
Priority to PT158199653T priority patent/PT3230316T/pt
Priority to CN202110181096.6A priority patent/CN112826934A/zh
Priority to SI201531805T priority patent/SI3230316T1/sl
Priority to ES15819965T priority patent/ES2907148T3/es
Priority to US15/534,030 priority patent/US20170326106A1/en
Priority to RS20220058A priority patent/RS62827B1/sr
Priority to JP2017530277A priority patent/JP7320919B2/ja
Priority to CN201580066980.8A priority patent/CN106999511A/zh
Priority to CA2970315A priority patent/CA2970315C/fr
Priority to LTEPPCT/US2015/065022T priority patent/LT3230316T/lt
Publication of WO2016090590A1 publication Critical patent/WO2016090590A1/fr
Priority to US16/453,242 priority patent/US20190381008A1/en
Priority to JP2020173951A priority patent/JP2021004262A/ja
Priority to AU2021107575A priority patent/AU2021107575A4/en
Priority to AU2021245214A priority patent/AU2021245214B2/en
Priority to JP2022152791A priority patent/JP2022183183A/ja

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16C—COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
    • G16C99/00—Subject matter not provided for in other groups of this subclass
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16C—COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
    • G16C20/00—Chemoinformatics, i.e. ICT specially adapted for the handling of physicochemical or structural data of chemical particles, elements, compounds or mixtures
    • G16C20/50—Molecular design, e.g. of drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

Definitions

  • Age related macular degeneration is a medical condition that usually affects older adults and results in a loss of vision in the center of the visual field (the macula) because of damage to the retina. It occurs in ′′dry′′ and ′′wet′′ forms. In the dry form, cellular debris called drusen accumulates between the retina and the choroid, and the retina can become detached. In the wet form (wAMD) , which is more severe, blood vessels grow up from the choroid behind the retina which is also named choroidal neovascularization (CNV) . As a result of CNV the retina can also become detached.
  • CNV choroidal neovascularization
  • VEGF vascular endothelial growth factor
  • wAMD can be also treated with photodynamic therapy with whereby closure of leakage is induced by laser light in combination with visudyne, an i.v. injectable photosensitizer.
  • the CATT research group compared the baseline characteristics, treatment frequency, visual acuity (VA) , and morphologic outcomes of eyes with>50%of the lesion composed of blood (B50 group) versus all other eyes (Other group) enrolled in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) .
  • Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to 3 different dosing regimens over a 2-year period. Reading center graders evaluated baseline and follow-up morphology in color fundus photographs, fluorescein angiography (FA) , and optical coherence tomography (OCT) .
  • FA fluorescein angiography
  • OCT optical coherence tomography
  • VA mean visual acuity
  • Mean lesion size in the “B50 group” decreased by 1.2 DA at both 1 and 2 years (primarily owing to resolution of hemorrhage) and increased in the “Other group” by 0.33 DA at 1 year and 0.91 DA at 2 years (P ⁇ 0.001) .
  • Lesion size decreased markedly through 2 years.
  • wAMD small active CNV lesion -type of wAMDor
  • II predominantly active CNV lesion-type of wAMD.
  • the location of the lesion can be subfoveal or juxtafoveal affecting the fovea.
  • the type of the lesion can be of all subtypes including predominantly classic, minimally classic, or occult.
  • sCNVwAMD sCNVwAMD
  • pCNVwAMD pCNVwAMD
  • sCNVwAMD is characterized by an active CNV lesion that occupies less than 50%of the total lesion size
  • pCNVwAMD is characterized by an active CNV lesion that occupies at least 50%of the total lesion size.
  • the location of the lesion can be subfoveal or juxtafoveal affecting the fovea.
  • the type of the lesion can be of all subtypes including predominantly classic, minimally classic or occult.
  • the size of the active CNV lesion as well as the total lesion size is determined using Fluorescence Angiography (FA) as described inthe MPS protocol [Macular Photocoagulation Study Group, Arch Ophthalmol 1991, 109: 1242-1257] .
  • treatments for wAMD can be also used for the treatment of patients with “sCNVwAMD” .
  • Such treatment of patients with “sCNVwAMD” may be as follows:
  • anti-VEGF therapy refers to all approved and non-approved treatments aiming to attenuate free VEGF in the eye. This includes particularly aflibercept, ranibizumab, bevacizumab, KH-902, and pegaptanib, but is not limited to these compounds.
  • Anti-VEGF treatment may be applied according to the following treatment schedules:
  • Treatment until visual acuity and/or retinal morphology e.g. as assessed by OCT, Fluoresceine Angiography, Indocyanine Angiography, Funduscopy, etc. ) stabilizes, followed by discontinuation of treatment. Re-initiation of treatment upon deterioration of visual acuity and/or retinal morphology.
  • steroids all available local or systemic application routes
  • slow-release or depot formulations e.g. Ozurdex, triamcinolone, dexamethasone, Iluvien, etc.
  • a total of 304 Chinese subjects with age-related n eo ovascular or wet age-related macular degeneration were enrolled in a randomized, double-blind clinical study to assess the efficacy of intravitreal (IVT) administrated aflibercept compared with on the mean change in BCVA (Best corrected visual acuity) from baseline to Week 28.
  • BCVA of the study eye was assessed according to the standard procedures developed for the ETDRS (Early Treatment Diabetic Retinopathy Study) adapted for Age Related Eye Disease Study (AREDS) .
  • ETDRS Early Treatment Diabetic Retinopathy Study
  • AREDS Age Related Eye Disease Study
  • CNV subfovealchoroidal neovascularization
  • ⁇ ETDRS best corrected visual acuity (BCVA) of 73 to 25 letters in the study eye (Snellen activity equivalent of 20/40 to 20/320 in the study eye) .
  • ⁇ Total lesion size is greater than 12 disc areas (30.5 mm 2 , including blood, scars and neovascularization) , as assessed by FA
  • ⁇ Sub-retinal hemorrhages that is ⁇ 50%of the total lesion area, or ifthe blood is under the fovea and is 1 or more disc areas in size. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV. )
  • VTE aflibercept
  • 228VTE+76 PDT aflibercept
  • 194 patients with active CNV lesions> 50% (147 VTE2Q8+47 PDT) and 106 patients with active CNV lesions ⁇ 50% (78 VTE2Q8+28 PDT) were included.
  • the lesion size was determined by a central reading center based on the MPS protocol [Macular Photocoagulation Study Group, Arch Ophthalmol 1991, 109: 1242-1257] .
  • the active CNV size as well as the total lesion size was measured using the FA.
  • Intravitreal injections of 2 mg aflibercept was superior to with a mean change from baseline BCVA Ietter score at week 28 of 14.0 (-29 to 59) VTE2Q8 group versus 3.9 (-36 to 43) PDT group (P ⁇ 0.0001) in the whole study population irrespective of the active CNV lesion size.
  • Figure 1 Mean change from baseline in ETDRS BCVA letter score by visit in subjects with an active CNV lesion ⁇ 50%of total lesion size at baseline.
  • the mean change in BCVA score (no. of letters) as measured by ETDRS from baseline at week 1 (V3) week 4 (V4) , week 8 (V5) , week 12 (V6) , week 16 (V7) , week 20 (V8) , week 24 (V9) , week 28 (V10) is shown for the VTE2Q8 group (solid line with diamonds) and the PDT group (dashed line with squares) .
  • the mean change in BCVA score from baseline is 12.7 for the VTE2Q8 group and 1.7 for the PDT group.
  • Figure 2 Mean change from baseline in ETDRS BCVA letter score by visit in subjects with an active CNV lesions ⁇ 50%of total lesion size at baseline.
  • the mean change in BCVA score (no. of letters) as measured by ETDRS from baseline at week 1 (V3) week 4 (V4) , week 8 (V5) , week 12 (V6) , week 16 (V7) , week 20 (V8) , week 24 (V9) , week 28 (V10) is shown for the VTE2Q8 group (solid line with diamonds) and the PDT group (dashed line with squares) .
  • the mean change in BCVA score from baseline is 16.7 for the VTE2Q8 group and 8.0 for the PDT group.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Theoretical Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

L'invention concerne des procédés de traitement d'une DMLA humide accompagnée d'une lésion de NVC active de moins de 50 % de la taille totale de la lésion, ainsi que des compositions pharmaceutiques destinées à être utilisées dans ces procédés.
PCT/CN2014/093548 2014-12-11 2014-12-11 Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active WO2016090590A1 (fr)

Priority Applications (25)

Application Number Priority Date Filing Date Title
PCT/CN2014/093548 WO2016090590A1 (fr) 2014-12-11 2014-12-11 Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active
CN202110181096.6A CN112826934A (zh) 2014-12-11 2015-12-10 具有小的活动性脉络膜新生血管病变的年龄相关性黄斑变性的治疗
US15/534,030 US20170326106A1 (en) 2014-12-11 2015-12-10 Treatment of age related macular degeneration with a small active choroidal neovascularization lesion
ES15819965T ES2907148T3 (es) 2014-12-11 2015-12-10 Tratamiento de la degeneración macular asociada a la edad con una pequeña lesión de neovascularización coroidea activa
PCT/US2015/065022 WO2016094673A1 (fr) 2014-12-11 2015-12-10 Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active
EP21207057.7A EP3985023A1 (fr) 2014-12-11 2015-12-10 Traitement de la dégénérescence maculaire liée à l'âge avec une petite lésion active de néovascularisation choroïdienne
EP15819965.3A EP3230316B1 (fr) 2014-12-11 2015-12-10 Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active
DK15819965.3T DK3230316T3 (da) 2014-12-11 2015-12-10 Behandling af aldersrelateret makuladegeneration med en lille aktiv choroidal neovaskularisationslæsion
RS20220058A RS62827B1 (sr) 2014-12-11 2015-12-10 Tretman staračke degeneracije žute mrlje koja ima malu aktivnu leziju neovaskularizacije sudovnjače
PL15819965T PL3230316T3 (pl) 2014-12-11 2015-12-10 Leczenie zwyrodnienia plamki żółtej związanego z wiekiem z małą aktywną zmianą neowaskularyzacji naczyniówki
PT158199653T PT3230316T (pt) 2014-12-11 2015-12-10 Ratamento de degenerescência macular relacionada com a idade com uma pequena lesão de neovascularização coroideia ativa
HRP20220066TT HRP20220066T1 (hr) 2014-12-11 2015-12-10 Liječenje makularne degeneracije povezane sa starenjem s malom aktivnom koroidnom neovaskularizacijskom lezijom
SI201531805T SI3230316T1 (sl) 2014-12-11 2015-12-10 Zdravljenje starostne degeneracije makule z majhno aktivno horoidalno neovaskularizacijsko lezijo
HUE15819965A HUE057653T2 (hu) 2014-12-11 2015-12-10 Kis aktív choroidális neurovaszkularizáció lézióval jellemzett idõskori makuladegeneráció kezelése
AU2015360496A AU2015360496B2 (en) 2014-12-11 2015-12-10 Treatment of age related macular degeneration with a small active choroidal neovascularization lesion
CN202210019267.XA CN114306575A (zh) 2014-12-11 2015-12-10 具有小的活动性脉络膜新生血管病变的年龄相关性黄斑变性的治疗
JP2017530277A JP7320919B2 (ja) 2014-12-11 2015-12-10 小さい活動性脈絡膜新生血管病変を有する加齢黄斑変性症の治療
CN201580066980.8A CN106999511A (zh) 2014-12-11 2015-12-10 具有小的活动性脉络膜新生血管病变的年龄相关性黄斑变性的治疗
CA2970315A CA2970315C (fr) 2014-12-11 2015-12-10 Utilisation d'agents anti-vegf pour traiter les lesions chez les patients atteints de degenerescence maculaire
LTEPPCT/US2015/065022T LT3230316T (lt) 2014-12-11 2015-12-10 Gydymas su amžiumi susijusios geltonosios dėmės degeneracijos su mažu aktyvios choroidinės neovaskuliarizacijos pažeidimu
US16/453,242 US20190381008A1 (en) 2014-12-11 2019-06-26 Treatment of age related macular degeneration with a small active choroidal neovascularization lesion
JP2020173951A JP2021004262A (ja) 2014-12-11 2020-10-15 小さい活動性脈絡膜新生血管病変を有する加齢黄斑変性症の治療
AU2021107575A AU2021107575A4 (en) 2014-12-11 2021-10-08 Treatment of age related macular degeneration with a small active choroidal neovascularization lesion
AU2021245214A AU2021245214B2 (en) 2014-12-11 2021-10-08 Treatment of age related macular degeneration with a small active choroidal neovascularization lesion
JP2022152791A JP2022183183A (ja) 2014-12-11 2022-09-26 小さい活動性脈絡膜新生血管病変を有する加齢黄斑変性症の治療

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PCT/CN2014/093548 WO2016090590A1 (fr) 2014-12-11 2014-12-11 Traitement d'une dégénérescence maculaire liée à l'âge accompagnée d'une petite lésion de néovascularisation choroïdienne active

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007138490A2 (fr) * 2006-05-25 2007-12-06 Heidelberg Engineering Gmbh Traitement photodynamique destiné au traitement de la dégénérescence maculaire liée à l'âge
WO2011050034A1 (fr) * 2009-10-21 2011-04-28 Genentech, Inc. Polymorphisme génétique dans la dégénérescence maculaire liée à l'âge

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007138490A2 (fr) * 2006-05-25 2007-12-06 Heidelberg Engineering Gmbh Traitement photodynamique destiné au traitement de la dégénérescence maculaire liée à l'âge
WO2011050034A1 (fr) * 2009-10-21 2011-04-28 Genentech, Inc. Polymorphisme génétique dans la dégénérescence maculaire liée à l'âge

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