A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema (LUDIC)

Novartis

Status and phase

Completed

Phase 4

Conditions

Macular Edema

Visual Impairment

Treatments

Drug: Ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01315275

2010-023315-34 (EudraCT Number)

CRFB002DFR08

Details and patient eligibility

About

The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.

Enrollment

394 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients >18 years of age who have signed an informed consent
Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
Patients with visual impairment due to focal or diffuse DME in at least one eye
Central Retinal thickness on OCT ≥ 250 microns in the central subfield
BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160)
Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.

Exclusion criteria

Ocular concomitant conditions/ diseases

Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
Active intraocular inflammation (grade trace or above) in either eye
Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
History of uveitis in either eye Systemic conditions or treatments
Active systemic infection
History of stroke < 3 months
Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl
Untreated diabetes mellitus
Blood pressure systolic > 160 mmHg and diastolic > 100 mmHg
Untreated hypertension
Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Others
Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding