RU2661621C2 - Method of prolongation and enhancement of the therapeutic effect of the action of angiogenesis inhibitors in the treatment of neovascular forms of macular degenerations - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to ophthalmology, and is intended to prolong and enhance the therapeutic effect of the action of angiogenesis inhibitors in the treatment of neovascular forms of macular degeneration. Method consists in introducing inhibitors of angiogenesis in the posterior subtenon space to the system of posterior short ciliary arteries. In this case, angiogenesis inhibitors are administered on a viscous carrier, which is used as a 1–3 % solution of hydroxypropyl methylcellulose in a volume of 1.0–2.0 ml.

EFFECT: use of the invention provides prolongation and enhancement of the therapeutic effect of the action of angiogenesis inhibitors in the treatment of neovascular forms of macular degeneration, which reduces the number of injections.

1 cl, 2 tbl, 2 ex

Description

The invention relates to medicine, in particular to ophthalmology, and relates to a method for the treatment of neovascular forms of macular degeneration.

A known method of treating neovascular forms of age-related macular degeneration by introducing angiogenesis inhibitors into the vitreous body (Schuko A.G., Zaitseva N.V. et al., 2012; Solomon S.D., Lindsley K. et al., 2014). The disadvantages of this method are: the threat of complications - endophthalmitis, hemophthalmus, retinal detachment, trauma of the lens, secondary glaucoma, infectious and proliferative process; insufficient volume of the vitreal chamber, which does not allow to increase the volume of injected drugs; rapid elimination of the drug from the hydrated vitreous body, which limits the duration of its therapeutic effect (1-2 months); the presence of histo-hematological barriers.

Approximate to the claimed method is the introduction of angiogenesis inhibitors into the subthenon space, which allows you to enter the drug in a volume of up to 1.5 ml to the system of the posterior ciliary arteries, which ensures the flow of the drug through the vascular system directly to the lesion. However, this method is used without a basic carrier, which does not allow prolonging the action of the drug sufficiently.

The closest to the claimed one is the method of administering drugs on a collagen sponge, but glucocorticosteroids were introduced using this method. The disadvantage of this method is the prolonged resorption of the base carrier (6-10 months), which is unacceptable for the protein structure of angiogenesis inhibitors, since denaturation can occur during this period.

In order to eliminate the above disadvantages and for a biologically justified prolongation and enhancement of the therapeutic effect, a method is proposed for treating neovascular forms of macular degeneration with angiogenesis inhibitors by introducing them into the posterior subtenon space, the method is characterized in that angiogenesis inhibitors are introduced on a viscous carrier, which use 1-3% a solution of hydroxypropyl methylcellulose in a volume of 1.0-2.0 ml, the preparations are thoroughly mixed before administration.

The method is implemented in the following sequence.

The introduction is performed under local epibulbar anesthesia. The surgical field is treated twice with 5% betadine solution, closed with a sterile napkin, and the eyelids are fixed with blepharostat. Preliminarily, an angiogenesis inhibitor is collected in an insulin syringe, then carefully mixed in a sterile syringe with a viscous carrier. The patient is asked to fix his gaze in the direction opposite to the injection site (in oblique meridians). 6-7 mm from the limb produce a 2-3 mm incision of the conjunctiva and tenon capsule using tweezers and conjunctival scissors. Then, a blunt-pointed scissors or spatula form a channel in the subtenon space up to the posterior pole of the eye between the macula and the optic nerve head. The introduction is carried out by means of a blunt bent cannula connected to a syringe containing a prepared combination of an angiogenesis inhibitor with a viscous carrier, which is introduced through the formed channel to the posterior pole of the eye.

After the introduction, the syringe with the cannula is carefully removed, the edges of the wound are matched with tweezers for a minute. Antibacterial drops were instilled into the conjunctival sac, an aseptic dressing was applied. Antibacterial drops are prescribed in the operated eye four times a day for two weeks.

Subsequent injections provided conjunctival-tenon access with a sequential change in the quadrants of the eyeball.

As a viscous carrier, 1-3% hydroxypropyl methylcellulose is used in a ratio of 2 parts to 1 part of an angiogenesis inhibitor in a minimum volume of 1 ml, and a maximum of 2 ml.

The positive aspects of the claimed method are:

1. The use of subtenon space allows you to: vary the volume of the input composition; lead directly to the vessels supplying the affected area; eliminate the side effects and risks of complications characteristic of endovitreal administration.

2. The use of a viscous carrier - 1-3% hydroxypropyl methylcellulose provides a longer residence time of the active drug (angiogenesis inhibitor) in the depot, at least twice as compared to endovitreal administration, since its viscosity allows the drugs to mix well, it is stable to various pH values in range from 3 to 11 and is tolerant to salts, inert to most active and auxiliary substances, as it has a more neutral pH environment (6.8-7.5) in contrast to other viscous carriers.

Thus, prolongation and enhancement of the therapeutic effect are achieved in the treatment of neovascular forms of macular degeneration by angiogenesis inhibitors.

Clinical example 1

Patient L., 61 years old, complained of decreased vision in his right eye, the appearance of a spot in front of the eye for 4 months. As a result of a comprehensive ophthalmological study, a diagnosis was made - age-related macular degeneration, wet form.

Treatment: the patient was administered three times the angiogenesis inhibitor in the posterior subtenon space on a viscous carrier, with an interval of 2 months (2nd injection) and 3 months (3rd injection). The dose of the drug at the first injection was 0.5 ml, with the second 0.4 ml, with the third 0.4 ml. As a result of treatment, an improvement in morphological and functional indicators was noted, which are presented in table 1.

Clinical example 2

Patient V., 65 years old, complained of decreased vision in her left eye, the appearance of a spot in front of the eye for three months. As a result of a comprehensive ophthalmological study, a diagnosis was made - age-related macular degeneration, wet form.

The treatment: the patient was administered three times the angiogenesis inhibitor in the posterior subtenon space on a viscous carrier with an interval of 2 months (2nd injection) and 4 months (3rd injection). The dose of the drug at the first injection was 0.5 ml, with the second 0.4 ml, with the third 0.4 ml. As a result of treatment, an improvement in morphological and functional indicators was noted, which are presented in table 2.

Claims (1)

A method for prolonging and enhancing the therapeutic effect of the action of angiogenesis inhibitors in the treatment of neovascular forms of macular degeneration, which consists in introducing angiogenesis inhibitors into the posterior subtenon space to the system of posterior short ciliary arteries, characterized in that the angiogenesis inhibitors are administered on a viscous carrier, which use 1-3 % hydroxypropyl methylcellulose solution in a volume of 1.0-2.0 ml.