Bevacizumab Versus Ranibizumab for Diabetic Retinopathy

Launched by URSULA SCHMIDT-ERFURTH, M.D. · Oct 16, 2007

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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)