Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ranibizumab

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)