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

Conditions

• Macular Edema, Cystoid
• Visual Acuity Reduced Transiently

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied.

Study Details

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.

Key Dates

First listed

Jan 28, 2016

Start date

Jan 18, 2016

Status verified

Oct 2019

Primary completion

Sep 7, 2018

Completion

Sep 7, 2018

Study Design

Enrollment

4 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Experimental: 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.

Primary Outcome Measure

Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit [ Time Frame: Baseline to 12 months ]