- Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in
the Eye
- Reduced visual acuity resulting from retinal thickening
- Female subjects of non-childbearing potential ≥18 years and male subjects greater than
or equal to 18 years. A subject is of childbearing potential if, in the opinion of the
investigator, he/she is biologically capable of having children and is sexually
active.
- Female subjects who are not of childbearing potential must meet at least one of the
following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure; or
- Achieved post-menopausal status, defined as: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level within the
laboratory's reference range for postmenopausal females.
- Severe Impaired Renal Function
- Any intraocular condition or previous surgery in either eye that would likely require
medical or surgical intervention during the study duration or if allowed to progress
untreated for the 16 weeks of study duration, would likely contribute to a reduction
in visual acuity.