Compare Safety/Efficacy of Labeled vs Wait-Extend Regimen of Lucentis in Turkish Patients With VI Due to DME

PHASE3CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

December 12, 2014

Primary Completion Date

September 12, 2017

Study Completion Date

September 12, 2017

Conditions
Diabetic Macular Edema
Interventions
DRUG

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.

DRUG

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.

Trial Locations (9)

34098

Novartis Investigative Site, Istanbul

35040

Novartis Investigative Site, Izmir

35340

Novartis Investigative Site, Izmir

41380

Novartis Investigative Site, Kocaeli

01330

Novartis Investigative Site, Adana

06100

Novartis Investigative Site, Ankara

06490

Novartis Investigative Site, Ankara

06500

Novartis Investigative Site, Ankara

06590

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY