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

An Open-label, Multicenter, Phase IV Study of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema in Current Medical Practice

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01315275

Acronym

LUDIC

Enrollment

394

Registered

2011-03-15

Start date

2011-02-28

Completion date

2012-08-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Visual Impairment

Keywords

visual impairment, macular edema, ranibizumab, visual impairment due to macular edema

Brief summary

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.

Interventions

DRUGRanibizumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)	6 months

Secondary

Measure	Time frame
mean average change in BCVA from baseline	6 months
if the letters gain after 2 injections is predictive from the letters gain at 6 months	6 months
mean number of injections needed to obtain a 10 letters gain	6 months
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments	6 months
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026