Until now, there have been no effective treatments for some ophthalmic diseases that have high social significance. Development of therapeutic approaches to such diseases may be complicated due to challenges in diagnosis and selection of clinical trial endpoints. The aim of the study was to analyse current approaches to selection of endpoints in clinical trials of ophthalmic drugs. Clinical efficacy studies of new medicinal products use surrogate endpoints in addition to clinical endpoints. However, currently used surrogate endpoints are not always relevant and do not fully reflect changes in the status of patients with chronic or progressive diseases. The study analysed published approaches to the selection of endpoints in clinical studies of ophthalmic drugs intended for the treatment of glaucoma, uveitis, dry eye syndrome, and age-related macular degeneration. It was demonstrated that the choice of surrogate endpoints in a clinical trial should take into account specific aspects of a particular disease. The assessment of dynamic patterns of changes in visual functions generally requires a complex approach for a comprehensive characterisation of the eye condition in a particular disease. The paper analyses the possibility of using potential surrogate endpoints in studies of the most common eye diseases, and highlights that none of them has been recommended for use in clinical trials or routine clinical practice.
Goal. The study of the content of cyclic nucleotides in the eye tissues both in normal and in experimental conditions of toxic-allergic uveitis and the assessment of their possible impact on the development of the pathological process. Material and methods. The concentration of cAMP and cGMP in the eye tissues of experimental animals (rabbits) was determined using standard Amerscham kits by radioimmune method. The samples were counted on a Mark III counter. The results were processed according to the Student's method. Results. A significant decrease in the concentration of cAMP in the cornea, retina and vasculature of the rabbit's eye was found, which significantly affects the processes of catabolism and energy production. The content of another messenger cGMP in the same tissues is also reduced, and this suppresses the processes of cell proliferation. Conclusion. The results obtained add significant new elements to the picture of uveitis development, which should be considered when developing sound approaches to its effective treatment. Key words: cyclic nucleotides, uveitis, regulation of metabolism, cAMP, cGMP, eye tissues.
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