87
Participants
Start Date
December 12, 2014
Primary Completion Date
September 12, 2017
Study Completion Date
September 12, 2017
Labeled regime arm
Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month.
Wait and Extend regime arm
Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
Novartis Investigative Site, Istanbul
Novartis Investigative Site, Izmir
Novartis Investigative Site, Izmir
Novartis Investigative Site, Kocaeli
Novartis Investigative Site, Adana
Novartis Investigative Site, Ankara
Novartis Investigative Site, Ankara
Novartis Investigative Site, Ankara
Novartis Investigative Site, Ankara
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY