Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
Overview
- Phase
- Phase 4
- Intervention
- ranibizumab
- Conditions
- Visual Acuity Reduced Transiently
- Sponsor
- Prof. Dr. Antonia M. Joussen
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
Patients with diabetic macular edema (DME) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-CBVA) and morphological (central retinal thickness-CRT) will be investigated. Patients will be randomized into two groups: Group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (Campus Benjamin Franklin) in Berlin with aim to reach the optimal glycemic control defined as HbA1c \< 6,5%. Further, triglycerides values \< 140 mg/dl and blood pressure \< 140/90 mmHg will be pursued. Second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention. BCVA, CRT and the number of required ranibizumab injections will we evaluated and compared between both study groups.
Investigators
Prof. Dr. Antonia M. Joussen
Prof. MD
Charite University, Berlin, Germany
Eligibility 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
Arms & Interventions
Regular Glycemic Control
Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control.
Intervention: ranibizumab
Intensified Glycemic Control
Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level \< 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake.
Intervention: ranibizumab
Outcomes
Primary Outcomes
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
Time Frame: Baseline to 12 months
Measured by the difference in ETDRS letters score between month 12 and baseline according to internal guideline of Charité department of ophthalmology.
Secondary Outcomes
- Time to Reach Target HbA1c(24 months)
- Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of Treatment(Baseline to 12 months)
- Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications(Baseline to 12 months)
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment(Baseline to 12 months)
- Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 6, 12, 24 and Baseline Visit(Baseline to 12 months)
- Macular Thickness Change at 6, 12, 18 and 24 Months Compared to Baseline(Baseline to 12 months)
- Number of Participants With Retinal Detachment, Central Retinal Artery Occlusion, or Endophthalmitis and/or Ocular Adverse Events That Are Related to Treatment(Baseline to 12 months)