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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Visual Impairment, Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab<br> | Drug: Ranibizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual impairment, macular edema, ranibizumab, visual impairment due to macular edema