Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Ranibizumab; Laser photocoagulation; Sham ranibizumab; Sham laser photocoagulation
Intervention description: Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.; Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.; Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.; Sham laser treatment administered at day 1.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME; Diabetic; macula; edema; ranibizumab; REVEAL

Summary:

      This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as
      adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian
      patients with visual impairment due to Diabetic Macular Edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type 1 or Type 2 diabetes mellitus according to American Diabetes
             Association (ADA) or World Health Organization (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 Diabetic Macular Edema 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 for study treatment unless, based on medical reasons, the
             investigator deems the other eye the more appropriate candidate for study treatment.

          -  The study eye must fulfill the following criteria at Visit 1:

               -  Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively,
                  using Early Treatment of Diabetic Retinopathy (ETDRS) chart-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 in either eye.

               -  Any active infection in either eye.

               -  History of uveitis in either eye.

               -  Uncontrolled glaucoma in either eye.

          -  Ocular treatments:

               -  Panretinal laser photocoagulation in the study eye within 6 months prior to or
                  during the study.

               -  Focal/grid laser photocoagulation in the study eye within 3 months prior to study
                  entry.

          -  Systemic conditions or treatments:

               -  History of stroke

               -  Renal failure requiring dialysis or renal transplant or renal insufficiency with
                  creatinine level > 2.0 mg/dL.

               -  Untreated diabetes mellitus

               -  Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg

          -  Compliance/ Administrative:

               -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply