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Clinical Trials
Kyowa Kirin
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients with Diabetic Macular Edema
Overview
DME (Diabetic Macula Oedema) is swelling in the macula, or central part of the retina (inner lining of the back of the eye that generates vision), and the main cause of vision impairment in diabetic patients. DME happens when high blood sugar levels affect the blood vessels in your eyes, making them weaker and more likely to leak fluid and/or blood. It may also cause new and more fragile blood vessels to grow where they shouldn’t grow. Leaking of fluid from blood vessels causes fluid build-up and thickens the retina which may result in loss of vision. Vascular endothelial growth factor (VEGF) is a protein that plays a significant role in this new blood vessel growth.
This study will assess the efficacy and safety of KHK4951 (eye drop) in the potential treatment for DME. This study also uses aflibercept (eye injection) as the treatment before starting KHK4951 eye drop treatment, as well as rescue treatment, which means that aflibercept may be used to help your DME if KHK4951 is not helping your condition and if it is deemed necessary by your study doctor.
As part of this study, suitable participants will be screened to determine their eligibility. If eligible, participants will be randomised to one of 3 treatment arms consisting of different dosages of KHK4951. The study runs for 12 months and would require participants to use the study eye drops daily.
For further information about this study please contact Cerulea on (03) 8638 5300 or email info@ceruleaclinicaltrials.org.au
- Principal Investigator
Associate Professor Sanj Wickremasinghe
DME (Diabetic Macula Oedema) is swelling in the macula, or central part of the retina (inner lining of the back of the eye that generates vision), and the main cause of vision impairment in diabetic patients. DME happens when high blood sugar levels affect the blood vessels in your eyes, making them weaker and more likely to leak fluid and/or blood. It may also cause new and more fragile blood vessels to grow where they shouldn’t grow. Leaking of fluid from blood vessels causes fluid build-up and thickens the retina which may result in loss of vision. Vascular endothelial growth factor (VEGF) is a protein that plays a significant role in this new blood vessel growth.
This study will assess the efficacy and safety of KHK4951 (eye drop) in the potential treatment for DME. This study also uses aflibercept (eye injection) as the treatment before starting KHK4951 eye drop treatment, as well as rescue treatment, which means that aflibercept may be used to help your DME if KHK4951 is not helping your condition and if it is deemed necessary by your study doctor.
As part of this study, suitable participants will be screened to determine their eligibility. If eligible, participants will be randomised to one of 3 treatment arms consisting of different dosages of KHK4951. The study runs for 12 months and would require participants to use the study eye drops daily.
For further information about this study please contact Cerulea on (03) 8638 5300 or email info@ceruleaclinicaltrials.org.au
- Principal Investigator
Learn more
View this study on ClinicalTrials.gov
See the ClinicalTrials.gov database listing for more detailed information about this study.