Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab

• Status: Terminated
• Trial end date: 2018-09-07
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Antonia M. Joussen
• Collaborator: Charite University, Berlin, Germany
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Patients with diabetic macular edema relevant to visual acuity

• OCT central retinal thickness ≥ 250µm

• HbA1c > 6,5% at initial visit

• BCVA ≤0.8 and ≥0.05

• Age ≥18 years

• Written patient informed consent given

Exclusion Criteria:

• Previous treatment with intravitreal drugs in last 6 months

• Vitreous hemorrhage as a consequence of proliferative retinopathy

• Pregnancy

• Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)

• Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)

• Systemic cortisone or anti-VEGF therapy

• Acute systemic or ocular infectious diseases