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Completed

NCT Number: NCT01315275

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

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.

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Key information

Conditions

Visual Impairment Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply

Treatment and study plan

ranibizumab

Drug

Primary outcomes

  1. proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)

    Time frame: 6 months

Secondary outcomes

  1. mean average change in BCVA from baseline

    Time frame: 6 months

  2. if the letters gain after 2 injections is predictive from the letters gain at 6 months

    Time frame: 6 months

  3. mean number of injections needed to obtain a 10 letters gain

    Time frame: 6 months

  4. mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments

    Time frame: 6 months

  5. efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: LUDIC

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2011
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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