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Use of a VEGF antagonist in treating retinopathy of prematurity

A technology of retina and antagonists, applied in the direction of antibody medical ingredients, medical preparations containing active ingredients, anti-animal/human immunoglobulin, etc., can solve problems such as permanent damage to the peripheral retina

Inactive Publication Date: 2016-03-02
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Peripheral retinal vessels continue to develop after treatment with intravitreal bevacizumab, whereas conventional laser photocoagulation causes permanent destruction of the peripheral retina

Method used

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  • Use of a VEGF antagonist in treating retinopathy of prematurity
  • Use of a VEGF antagonist in treating retinopathy of prematurity
  • Use of a VEGF antagonist in treating retinopathy of prematurity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Pharmacokinetic Model for Predicting Ocular and Systemic Exposure of Intravitreal Ranibizumab in Infants

[0082] To model ocular and systemic exposures of ranibizumab and bevacizumab in infants, two key relationships were established based on published data:

[0083] 1. Prediction of ocular clearance and vitreous concentration in relation to children's age and vitreous chamber depth and vitreous gel density;

[0084] 2. Prediction of the relationship between child age and weight for systemic concentrations and PK parameters for systemic deployment (allometric scaling).

[0085] Vitreous concentrations of ranibizumab and bevacizumab were calculated using vitreous volumes. This is calculated from the partial spherical volume with a height equal to the vitreous chamber depth (VCD) and a diameter equal to the axial length (AL) of the eye. Using linear regression models and published data (Fledelius (1992) Acta Ophthalmol Suppl 204:10-15), the association between VCD and ...

Embodiment 2

[0091] Determination of the ranibizumab dose for the treatment of infants with ROP

[0092] Using the pharmacokinetic model described in Example 1, predicted ocular and systemic exposures in infants receiving intravitreal ranibizumab were compared with exposures in adults receiving 0.5 mg ranibizumab intravitreal injection , because the efficacy and safety profile in adults at this dose level and dosing model is known.

[0093] For three different parameters: (i) maximum serum concentration (Cmax), which provides a measure of acute toxicity, (ii) serum area under the curve (AUC), which provides an indication of potential long-term toxicity associated with continuous inhibition of systemic VEGF Metrics, and (iii) Vitreous AUC, which provides a measure of efficacy correlated with continuous inhibition of ocular VEGF, to calculate the Ratio of Exposure to Ranibizumab.

[0094] The ratio of predicted exposure in infants to exposure in adults represents a measure of the likelihood...

Embodiment 3

[0100] Clinical study to determine the effect of two different doses of intravitreal ranibizumab in infants with ROP

[0101] The proposed study examines during a 16-week post-injection period: (i) whether ranibizumab provides similar therapeutic effects in ROP as reported in the BEAT-ROP study for bevacizumab; (ii) ranibizumab whether a lower dose of ranibizumab could achieve similar results in controlling ROP and (iii) whether the two doses of ranibizumab differed in their effect on systemic VEGF inhibition. This first phase is followed by a 5-year non-intervention period during which infants receiving treatment will undergo two long-term ophthalmic and pediatric developmental assessments (at 2 and 5 years), including VEGF-dependent organs such as the heart, lungs , vascular system and brain directional examination.

[0102] The study will enroll 40 patients who need treatment for zone I ROP (stage 1+, 2+, 3+ / - or AP-ROP) or central zone II ROP (stage 3+) according to the c...

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Abstract

The present invention relates to the use of a VEGF antagonist in the treatment of retinal neovascular disorders in infants. In particular, the invention provides a method for treating an infant having retinopathy of prematurity (ROP), wherein said method comprises administering to the eye of an infant a VEG F antagonist that either does not enter or is rapidly cleared from the systemic circulation. The term infant is typically used to refer to young children from birth up to the age of 12 months. The VEGF antagonist may be administered intravitreally, e.g. through injection, or topically, e.g. in form of eye drops.

Description

technical field [0001] The present invention is in the field of treating retinal diseases in infants. Background technique [0002] Retinal neovascularization and retinal detachment are hallmarks of retinopathy of prematurity (ROP). Between 50 and 65% of premature infants weighing less than 1250 g at birth have this form of retinopathy. ROP is the leading cause of pediatric blindness worldwide. [0003] Depending on the severity of ROP, standard of care ranges from watchful waiting to surgical intervention. The main purpose of treatment is to restore retinal function and preserve vision. Treatment is generally not recommended for infants with mild or moderate abnormal blood vessel growth because in most of these infants the disease does not progress further and resolves on its own over time. [0004] More advanced ROP is associated with severe abnormal retinal neovascularization, often secondary to partial or complete retinal detachment, requiring therapeutic interventio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/22
CPCA61K2039/505A61K2039/545C07K2317/94A61K38/1709C07K16/22A61P27/02A61K39/395A61B18/02A61F9/00823
Inventor G·布莱恩S·阿克赛诺夫
Owner NOVARTIS AG
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