Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab (DORO)

Prof. Dr. Antonia M. Joussen

Status and phase: Terminated; Phase 4

Conditions: Macular Edema, Cystoid; Visual Acuity Reduced Transiently

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02665689

DORO001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Regular Glycemic Control

Active Comparator group

Description:

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.

Treatment:

Drug: ranibizumab

Intensified Glycemic Control

Experimental group

Description:

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.

Treatment:

Drug: ranibizumab