A Randomized, Double-masked Study With Intraocular Bevacizumab Compared With Intravitreal Ranibizumab in Patients With Persistent Diabetic Macular Edema or Persistent Active Neovascularisation Following Lasercoagulation
Inclusion Criteria:
- Age ≥18 years
- Patients with type 1 or type 2 diabetes mellitus
- HbA1C between 6% and 9 %.
- Patients with persistent diabetic macular edema with center involvement following
completed grid lasercoagulation in the study eye
- Patients with persistent active neovascularisations following completed panretinal
lasercoagulation (at least 2000 spots) in the study eye
- Last perifoveolar laser treatment 3 months before study entry
- Central macular thickness (macular edema) of at least 300 - 550 microns in the
central subfield as measured by OCT
- Not eligible for any currently approved treatments or experimental protocols
- Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/200 (Snellen
equivalent) in the study eye
- Patients with decrease in vision in the study eye due to foveal thickening from
diabetic macular edema and not to other causes, in the opinion of the investigator
Exclusion Criteria:
- A condition that would preclude a patient for participation in the study in opinion
of investigator, e.g., unstable medical status including glycemic control and blood
pressure
- History of systemic corticosteroids within 3 months prior to randomization or
topical, rectal or inhaled corticosteroids in current use more than 3 times per week
- Panretinal laser photocoagulation within the past 3 months or macular laser
photocoagulation within the past 3 months in the study eye
- Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3
months in the study eye
- Previous participation in clinical trial involving anti-angiogenic drugs (pegabtanib
sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.)
- History of submacular surgery or other surgical intervention for diabetic macular
edema except grid lasercoagulation in the study eye
- Previous participation in any studies of investigational drugs within 1 month
preceding Day 0 (excluding vitamins and minerals)