A randomized, double-masked, multicenter, phase II study assessing the safety and efficacy of two concentrations of ranibizumab (intravitreal injections) compared with non-treatment control for the treatment of diabetic macular edema with center involvement

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Inclusion Criteria 1. Male or female patients >18 years of age who have signed an informed consent 2. Patients with type 1 or type 2 diabetes mellitus diagnosed ≥24 months prior to screening and a documented history of stable HbA1c ≥6.5% and ≤9.5% at the time of screening (stable HbA1c values are defined as those that do not differ at monthly assessments by more than 0.5% HbA1c). Any one of the following will be considered to be sufficient evidence that diabetes is present ? Current regular use of insulin for the treatment of diabetes ? Current regular use of oral antihyperglycemia agents for the treatment of diabetes ? Documented diabetes by ADA and/or WHO criteria (see Study Operations Manual) 3. Patients with diabetic macular edema with center involvement in at least one eye, including those with focal or diffuse DME, as demonstrated with stereoscopic fundus photography, fluorescein angiography and optical coherence tomography within 28 days of the baseline treatment. For this eye to achieve eligibility statue it must fulfill the following three criteria at Visit 1: ? The central macular thickness must be ≥300 μm in the center subfield, as assessed by OCT and confirmed by the central reading center. ? BCVA score between 69 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/40 to 20/160) ? Decrease in vision is due to foveal thickening from DME and not due to other causes, in the opinion of the investigator 4. Patients with DME without previous laser photocoagulation or patients who have been treated at least 6 months preceding Day 1 with mild focal laser photocoagulation consisting of no more than 30 laser burns that are at least 500 μm from the center of the fovea will be allowed to enter the study. 5. Only one eye will be selected for study treatment (study eye). If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment. The medical reason for selecting the study eye having the better visual acuity must be described in the eCRF 6. The BCVA score in the non-study eye (fellow eye) must be ≥24 letters (approximate Snellen equivalent of 20/320) at Visit 1 7. Patients for whom, in the opinion of the investigator, laser photocoagulation in the study eye can be withheld for at least 3 months after randomization 8. Willing to return for all scheduled visits
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A condition that in the opinion of the investigator would preclude a patient's participation in the study, e.g., unstable medical status including glycemic control and blood pressure. Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled. Patients with hypertension for whom a change in antihypertensive treatment was initiated within 2 months preceding Day 1 should not be enrolled unless blood pressure is maintained for at least 1 month prior Day 1 below 150/95 mm Hg by antihypertensive treatment 2. History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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