Novartis Pharmaceuticals is sponsoring a clinical research trial for men and women, ages 18-85 years with Diabetic Macular Edema.
Diabetic retinopathy (DR) is the most common eye disease in patients with both type 1 and type 2 diabetes. Diabetic Macular Edema (DME) is a serious eye condition occurring at any stage of Diabetic Retinopathy. DME is caused by the buildup of fluid in the macula – or the central portion in the retina where vision is clearest. Over a period of time, DME can cause vision problems or even blindness.
To learn more about Diabetic Macular Edema, click here.
This study is designed to assess the effect that the study drug has on subjects with Diabetic Macular Edema. The effects of the study drug will be compared to the effects of a drug already available on the market to treat DME, called Lucentis®.
If you agree to participate in this study, there will be a screening and baseline period of up to 60 days where certain tests will be done to see if you qualify for the study.
If your results show that you are qualified, you will be randomized to receive either:
Study drug alone
A combination of study drug + Lucentis®
Being 'randomized' means that you are put into one of the study treatment groups by chance, and neither you nor your study doctor can choose which group you will be in. However, your study doctor can find out which medication you were taking if there is an emergency. You will be dosed via an intraocular injection (i.e., an injection into your eye) once every 4 weeks for a total of 3 doses. After this study treatment period, there will be a 3 month ‘extension period’ where you will be checked by the study doctor every 4 weeks and may receive Lucentis® if the study doctor believes it is necessary.
To see if you may be eligible, click here for a pre-screener.
Subjects who participate in this trial must meet the following requirements:
Must be at least 18 years of age and no older than 85 years.
Must be diagnosed with type I or type II diabetes mellitus
Have Diabetic Macular Edema in at least one eye (the ‘study eye’)
Have not received prior treatment for DME in the study eye, with the exception of some laser treatments (focal lasers outside the fovea)
Don’t have Proliferative Diabetic Retinopathy
Have not had cataract surgery in the study eye within the last 6 months
Have not had glaucoma filtration surgery or corneal transplant surgery in the study eye
Do not have a history of chronic renal failure requiring dialysis or kidney transplant
Don’t have any progressive disease of the retina or optic nerve in the study eye (i.e., uveitis, rod-cone dystrophy, glaucoma)
Subjects who are eligible and decide to enroll in this trial:
Will be dosed once every 4 weeks for a total of 3 doses via intravitreal (intraocular) injection. i.e. injection into the eye
Will not be charged to participate
May receive compensation for time and travel costs
May withdraw from the trial at any time, for any reason
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