GCT has performed multiple clinical trials in Ophthalmology (see some examples in the table below). We are closely familiar with key opinion leaders in ophthalmology, as well as high-recruiting investigative sites, and will gladly apply this knowledge to assure the successful completion of your planned clinical program.
|Phase||# Pnts||# Sites||Countries||Indication||Sponsor|
|I||34||8||Russia||Age-related Macular Degeneration||US Biopharma|
|III||185||7||Russia||Ocular Hypertension, Open-Angle Glaucoma||Big Pharma|
|Device||54||1||Russia||Dry Eye Signs and Symptoms in patients after Refractive Surgery||EU Pharma/Medtech|
|III||105||6||Russia||Ocular Hypertension, Open-Angle Glaucoma||Big Pharma|
|IV||300||30||Russia||Age-related Macular Degeneration||Big Pharma|
|III||155||10||Russia, Bulgaria, Romania||Classic and Occult Subfoveal Choroidal Neovascularization associated with Age-related Macular Degeneration||US Pharma|
|II||25||4||Russia||Subfoveal Choroidal Neovascularization in subjects with Pathologic Myopia||US Biotech|
|II||125||6||Ukraine||Ocular Hypertension, Open-Angle Glaucoma||Big Pharma|
GCT has an exclusive access to the huge database of potential investigators, being the official Media Partner for “The White Nights” International ophthalmology congress, Russia’s leading event for local, CIS and international ophthalmology professionals, which takes place annually in St. Petersburg. Organized by St. Petersburg Medical University and lasting for about a week, the Congress program is rich with lectures featuring the World’s Ophthalmology opinion leaders, devoted to the new technologies of treatment for glaucoma; cataract surgery; corneal and conjunctival dystrophic-degenerative disease treatment; neuro- ophthalmology; pharmaceutical and surgical treatment of retinal and choroidal vascular disease; orbital pathology; refraction surgery; vision correction and other therapeutic, technological and research aspects of the modern ophthalmology, various training sessions and entertainment.
Every year the Congress attracts about 2 000 ophthalmology professionals from all over Russia, former USSR, Europe, Middle East and Americas, making this conference exhibition the main flagship event in the region for most major ophthalmic pharmaceutical and medical device companies.
The quality of clinical research data coming from Russia and CEE region is comparatively high. For example, the percentage of FDA/EMA approved drugs studied within international clinical trials placed in part in Russia is increasing (29% in 2010, 33% in 2011, 37% in 2012, and 65% in 2013). As per the EMA report of 08-Apr-2013, Russia is among five top-enrolling countries in clinical research worldwide. Moreover, including Russia into your clinical study, you escape the need to conduct local registration clinical studies in future and save time and costs to launch to the Russian market!
According to the 2013 report “Analysis of the present-day ophthalmology situation in Russia”, in adult population more than 16 mln cases of visual impairment were registered during 2012. More than 1/3 of them were newly diagnosed. The incidence rate of the diseases of the eye and adnexa is 11297.7 per 100 000 people. In children, this incidence rate is 13242.5 per 100 000 with a total number of visual impairment cases amounting to 3.5 mln. Half of the cases were newly diagnosed.
- Refractive errors – 5 mln people
- Cataract – 2.64 mln people
- Glaucoma – 1.1 mln people
- AMD – 240 000 people
In Ukraine ophthalmic pathologies conclude 5% from the total disease number and rank 6th which makes them one of the most wide-spread groups in the Ukrainian incidence rates structure. While the general proportion of such diseases remains the same, the number of cases grows annually: during the period from 2001 to 2008 the number of cases of visual impairment has increased by 25%.
- Cataract – 944 (per 100 000 people)
- Conjunctival diseases – 839 (per 100 000 people)
- Myopia – 664 (per 100 000 people)
- Glaucoma – 450 (per 100 000 people)
According to WHO, the major cause of blindness in industrialized countries including Eastern Europe is age related macular degeneration. The other conditions comprise cataract, glaucoma, diabetic retinopathy and uncorrected/uncorrectable refractive errors, along with low vision.
As per population-based surveys in Eastern Europe, the prevalence of blindness is 0.49%. The main causes of blindness are cataract (20%), age related macular degeneration (20%), glaucoma (20%), optic nerve atrophy (10%), and diabetic retinopathy (7%). The most frequent eye disorders are cataract (51%), senile macular degeneration (14%), diabetic retinopathy (10%), glaucoma (6%), and a combination of them.
We will be happy to provide more information about Ophthalmology studies in CEE and Russia. Please contact us or simply use the form below. A representative will respond shortly.