Compare Safety/Efficacy of Labeled vs Wait-Extend Regimen of Lucentis in Turkish Patients With VI Due to DME
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Labeled regime arm; Wait and Extend regime arm
Intervention description: Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month.; Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema, DME, ranibizumab, wait and extend

Summary:

      To explore a more clinical feasible treatment regime with ranibizumab for DME to provide
      satisfactory treatment effect with a lower number of visits and injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  M or F patients >18 years of age who have signed an informed consent

          -  Patients with Type 1 or Type 2 DM (according to ADA or WHO guidelines) with HbA1c not
             more than 12.0% 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 macular edema with center
             involvement in at least one eye, as demonstrated with color fundus photography,
             fluorescein angiography and OCT within 28 days of the baseline treatment. 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:

          -  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

        Exclusion Criteria

          -  Concomitant conditions in the study eye according to defined criteria such as
             infection, inflammation, uncontrolled glaucoma

          -  Active PDR in the study eye or evidence of vitreomacular traction in either eye

          -  Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) £ 24
             letters at Visit 1

          -  Concomitant systemic condition according to defined criteria, eg. history of stroke,
             uncontrolled diabetes, renal failure, unsatisfactory controlled hypertension

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days until the expected PD effect has returned to baseline, whichever is longer.

          -  History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes.

          -  History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using effective methods of contraception during
             dosing of study treatment.

        Women are considered post-menopausal and not of child bearing potential if they have had 12
        months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age
        appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy
        (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of
        oophorectomy alone, only when the reproductive status of the woman has been confirmed by
        follow up hormone level assessment is she considered not of child bearing potential.