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

NCT02665689 | Terminated Phase 4 Results

• 1 other identifier: DORO001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Acuity Reduced Transiently; Macular Edema, Cystoid

Keywords

Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control

Outcome Measures

Primary Outcomes (1)

• Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit

  Measured by the difference in ETDRS letters score between month 12 and baseline according to internal guideline of Charité department of ophthalmology.

  Baseline to 12 months

Secondary Outcomes (7)

• Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of 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

• Time to Reach Target HbA1c

  24 months

• Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications

  Baseline to 12 months

Study Arms (2)

Regular Glycemic Control

ACTIVE COMPARATOR

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.

Drug: ranibizumab

Intensified Glycemic Control

EXPERIMENTAL

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.

Drug: ranibizumab

Interventions

ranibizumab DRUG

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

Intensified Glycemic Control; Regular Glycemic Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Antonia M. Joussen: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Department of Ophthalmology, Charite, Berlin

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Recruitment was stopped prematurely by the sponsor after enrolment of four patients since enrollment pace was far below target. Due to the limited number of patients, no conclusions in respect to the study aims can be made.

Results Point of Contact

• Title: Prof. Dr. Antonia Joussen
• Organization: Charité University, Berlin

antonia.joussen@charite.de

+49 30 84452331

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Observer-masking (assessment of BCVA, macular thickness, capillary drop-out) is done to guard against detection bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 28, 2016
• Study Start: January 18, 2016
• Primary Completion: September 7, 2018
• Study Completion: September 7, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)