Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
Condition: Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Intervention: RFB002; Dexamethasone
Intervention description: 0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20.; Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; Dexamethasone was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Choroidal Neovascularization; Signs and Symptoms; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis Sensation Disorders; Dexamethasone acetate; Dexamethasone; Dexamethasone 21-phosphate; BB 1101; Anti-Inflammatory Agents; Therapeutic Uses; Vision, Low; Signs; Vision Disorders

Summary:

      The study is intended to characterize the clinical benefit regarding safety and efficacy of a
      long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and
      a 3-month follow-up period, following the initial 6-month treatment in the respective core
      studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have completed the core study assessments at month 6 of study
             CRFB002EDE17 or CRFB002EDE18, respectively

        Exclusion Criteria:

          -  Patients who experienced an uncontrollable rise in IOP during the core study
             CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable
             level of < 25mmHg.

          -  Use of other investigational drugs

          -  Current use or likely need of systemic medications known to be toxic to the lens,
             retina or optic nerve

          -  History of hypersensitivity to Ranibizumab or Ozurdex or any component of the
             ranibizumab respectively Ozurdey formulation

          -  Any type of advanced, severe or unstable disease or its treatment, that could
             interfere with evaluations or put the patient at special risk

          -  Women

          -  who were pregnant or breast feeding (pregnancy defined as the state of a female after
             conception and until the termination of gestation, confirmed by a positive hCG
             laboratory test (>5 mIU/mL)

          -  who were menstruating and capable of becoming pregnant* and not practicing a medically
             approved method of contraception (Pearl Index <1**)*** during and up to at least 4
             weeks after the end of treatment. A negative pregnancy test (serum) for all women and
             for girls entering menarche was required with sufficient lead time before
             randomization

               -  definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6
                  months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or 6 weeks post
                  surgical bilateral oophorectomy with or without hysterectomy

                    -  examples of particularly reliable methods with Pearl Index (PI) <1,
                       according to guidelines of "Deutsche Gesellschaft für Gynäkologie und
                       Geburtshilfe":

                         -  Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)

                         -  Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr.)

                         -  Contraceptive patch (EVRA®, PI= 0.72 uncorr.; 0.9 corr.)

                         -  Estrogen-free ovulation inhibitors (Cerazette®, PI=0.14)

                         -  Progestin-containing contraceptives (Implanon®, PI=0-0.08)

                         -  Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)

                         -  Intra-uterine progestin device (Mirena®, PI=0.16)