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K uban State Medical University, Ophtalmology Department 1

K uban State Medical University, Ophtalmology Department 1. K rasnodar Regional Clinical Hospital named after Prof. Ochapovsky, Eye Microsurgery Department 2. K rasnodar branch IRTC Eye Microsurgery named after Acad. S.N. Fedorov 3. Krasnodar, Krasnodar Region, Russian Federation.

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K uban State Medical University, Ophtalmology Department 1

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  1. Kuban State Medical University, Ophtalmology Department 1 Krasnodar Regional Clinical Hospital named after Prof. Ochapovsky, Eye Microsurgery Department 2 Krasnodar branch IRTC Eye Microsurgery named after Acad. S.N. Fedorov 3 Krasnodar, Krasnodar Region, Russian Federation EFFECTIVENESS AND SAFETY OF BRIMONIDINE-PURITE IN GLAUCOMA TREATMENT : NEUROPROTECTION AND INFLUENCE ON THE OCULAR SURFACE (PRELIMINARY RESULTS) 1,2 Yanchenko S.V., MD, PhD; 1,3 Sahnov S.N., MD 1,2 Malishev A.V., MD, 1 Varlashina E.V.; 1 Shipilov V.A.; 1 Rudashova A.S.; 2 Karapetov G.Y.; 1 Mirgorodskiy M.N., 1 Avetisyan A.A., 1 Horolskaya V.E. 1 2 3 Alliance for European Ophthalmic Treatment Advances, Belgium, Brussels, 15-17 March 2013

  2. PURPOSE : to evaluate the clinical efficacy and safety brimonidine-Purite (Alfagan-P; Allergan, Irvine, CA) in glaucoma patients. PATIENTS : 35 open-angle initial stage (early) glaucoma patients (61 eyes; female-23; male-12; 55-65 years old) were included in this 8-month prospective multicentre clinical trial. Inclusion criteria: the lack of antihypertensive therapy in anamnesis; the cornea thickness ≥ 450μm ≤ 550 μm (by OCT data). Exclusion criteria:non-glaucomatos lesions of the retina or optic nerve ; symptoms and signs of the ocular surface diseases; diabetes mellitus; severe cardio-vascular diseases; the ineffectiveness of the hypotensive action; severe local or systemic side effects. Intervention:all patients received brimonidine-Purite, three times daily. Examinations conducted before the beginning of therapy, after 2 weeks and after 1, 2, 4, 6, 8 months of treatment. Statistical processing of the results included: the calculation of the average of the indicators and their standard deviations (M±s); Student’s test; linear regression; criterion χ2. Differences were statistic significant at p<0.05 and χ2>3.

  3. METHODS: • visiometry, refractometry, biomicroscopy (Nidek, Japan), honyoscopy, • binocular ophthalmoscopy; • tonometry by Maklakov: intraocular pressure (IOP) was measured at 8.00 and 10.00 • AM (prior to brimonidine instillation and in 2 hours after her, that is at a minimum and the • peak of his hypotensive actions) with the calculation of the mean IOP. The criterion of • effectiveness of the hypotensive action of the brimonidine-Purite was reduction of mean • IOP up to the target level (22-24 mm Hg by Maklakov’s tonometry or 17-19 mm Hg by • Goldman tonometry) under the condition of minimal fluctuations of IOP (Alekseev V.N. et al. • // National guidelines on glaucoma, 2010). • documentation and objective assessment of the optic nerve head (Nidek, • Japan). The main criterion was vertical cup/disk ratio (C/D ratio V) dynamic. • standard automated perimetry (Optos AP-300, Australia; strategy - glaucoma • fast threshold)with the calculation of the AD (average defect, dB) and PD • (pattern defect, dB) coefficients. • optical coherent tomography (OptoVue, USA):pahimetry; determination of the • average thickness of the retinal nerve fiber layer (RNFL) and average thickness of • the ganglion cells complex (GCC); measurement of the height of the lower tear meniscus, • the angle of wetting of the cornea, the thickness of the anterior corneal epithelium • ocular surface examination: the integral indicator of the subjective discomfort • (by Brzheskiy V.V., 2003) and the severity of the conjunctival hyperemia (4-point scale); • Shirmer test; Norn test; index of xerosis (lyssamine green;by Bijesterveld O.P., 1969; • 9-point scale).

  4. METHODS: • Documentation of photo and video images • of the ocular surface and their computer • morphometric analyses were performed by • using the author's technology Yanchenko S.V. et al. // Software program «Assessment of the status of the ocular surface in dry eye». Registered in the Russian Register of computer programs on 25 November 2009. № 2009616529. • In addition to the above, take into account the presence and severity of the possible • systemic side effects of therapy (in points 4-point scale).

  5. RESULTS: Two of the 35 patients refused to participate in the study after 1 follow-up. Analysis of the results of the treatment of 33 glaucoma patients (57 eye) has shown good efficacy and safety of the brimonidine-Purite. • Effective anti-hypertensive action was seen in 97% cases. • By the end of the first month of observation systemic side effect • (sensation of «dryness of the mouth»; 1-point of 4-point scale) • was noted in 2 patients (6.1%). • Local side effect (conjunctiva hyperemia; 1-point, 4-point scale) was • observed in 12.2% patients. • «Burning» after instillation of the preparation was in 9.1%. • Only one of these patients (3%) had moderate subjective • discomfort after instillation («burning» > 2-points of 4-point scale). At the • insistence of the patient after the second follow-up appointment he was • excluded from the study. By the end of the first month of observation in the study were 31 patients (53 eyes).The results of their examination are shown in table

  6. RESULTS: TABLE. Dynamics of clinical and functional data in glaucoma patients underwent brimonidine-Purite instillation

  7. RESULTS: Within 8 months of therapy was not statistically significant dynamic of the morphometric indicators of the optic nerve head 03.11.2012 03.03.2012 C/D ratio (vertical) = 0.64 C/D ratio (vertical) = 0.63

  8. RESULTS: By the end of 8 months of observation, the average thickness of the nerve fibers of the retina (RNFL) remained stable in all patients, by a tendency to its increase. However, these changes were statistically insignificant.

  9. RESULTS: The average thickness of the ganglion cells complex (GCC) remained stable during the whole period of observation, by a tendency to its increase. Apparently, the stabilization of the C/D ratio (V), as well as, the RNFL and GCC thickness in glaucoma patients was due to both direct and indirect neuroprotective effect of the brimonidine-Purite. The tendency to increase the RNFL and GCC thickness can be explained by the ability of ganglion cells to the intracellular regeneration, accompanied by an increase in the size of cells and their axons.

  10. RESULTS: The functional result of the neuroprotective action of the studied preparation was a significant positive dynamics of the coefficients of AD and PD

  11. RESULTS: By the end of 8 months of observation has not been observed statistically significant increase in the frequency and intensity of the local side effects of therapy, compared with the state of the end of the 1st month of treatment. 03.03.2012 03.11.2012

  12. RESULTS: During the whole period of monitoring indicators characterizing the objective state of the ocular surface (the height of the lower tear meniscus, the angle of wetting of the cornea, the thickness of the anterior epithelium of the cornea is still within the normal range in all patients (by OCT data). 03.11.2012 03.03.2012

  13. RESULTS: According to the data of computer morphometry indicator of xerosis remained within the normal range throughout the entire observation (less than 3 points on a 9-point scale of Bijesterveld O.P). 03.11.2012 3.03.2012

  14. Conclusion. In our opinion, the preliminary results suggest that the brimonidine-Purite has neuroprotective potential and a good safety profile. However, for a more detailed assessment of the neuroprotective impact of the product and the study of its influence on the ocular surface it is necessary to conduct further clinical observations.

  15. THANK YOU FOR YOUR ATTENTION Vlyan2000@mail.ru

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