Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
Condition: Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Diabetes Mellitus; Edema
Intervention: Ranibizumab
Intervention description: Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 373.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME; Diabetic macula edema; RETAIN; ranibizumab

Summary:

      The purpose of this study is to demonstrate that two investigational treatment regimens have
      the potential to result in a superior visual acuity improvement as compared to a ranibizumab
      pro re nata (PRN=as needed) treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

        Patient

          -  Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes
             Association or World Health Organization [WHO] guidelines) with glycosylated
             hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet,
             exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must
             have been stable for at least 3 month.

        Ocular

          -  Patients with visual impairment due to DME in at least one eye who are eligible for
             laser treatment in the opinion of the investigator. If both eyes are eligible, the one
             with the worse visual acuity, as assessed at Visit 1, will be selected by the
             investigator as the study eye.

          -  BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment
             Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing
             distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.

          -  Concomitant conditions in the study eye are only permitted if, in the opinion of the
             investigator, they do not prevent improvement of visual acuity on study treatment.

        Exclusion Criteria:

        Patient Compliance/ Administrative

          -  Pregnant or nursing (lactating) women.

        Ocular medical history

          -  Active intraocular inflammation (grade trace or above) in either eye at enrollment.

          -  Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis,
             endophthalmitis) in either eye at the time of enrollment.

          -  History of uveitis in either eye at any time.

          -  Structural damage within 0.5 disc diameter of the center of the macular in the study
             eye likely to preclude improvement in visual acuity following the resolution of
             macular edema.

          -  Uncontrolled glaucoma in either eye at screening.

        Prior Ocular treatments

          -  Panretinal laser photocoagulation in the study eye within 6 months prior to
             randomization.

          -  Focal/grid laser photocoagulation in the study eye within 3 months prior to
             randomization.

          -  Treatment with anti-angiogenic drugs in either eye.

        Systemic conditions or treatments

          -  History of stroke within 6 months prior to enrollment.

          -  Renal failure requiring dialysis.

          -  Untreated diabetes mellitus.

          -  Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.

        Other protocol-defined inclusion/exclusion criteria may apply