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

NCT ID: NCT02665689

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-18
• Study Completion Date: 2018-09-07

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.

Conditions

Visual Acuity Reduced Transiently; Macular Edema, Cystoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ranibizumab

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

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

Interventions

ranibizumab

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Prof. Dr. Antonia M. Joussen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Antonia M. Joussen

Prof. MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Ophthalmology, Charite, Berlin

Berlin, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DORO001

Identifier Type: -

Identifier Source: org_study_id