An Open-label, Multi-center, 6-month Extension Study Comparing the Long-term Efficacy and Safety of Lucentis (Ranibizumab) Intravitreal Injections Versus Ozurdex (Dexamethasone) Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) Who Have Completed the Respective Core Study (CRFB002EDE17 or CRFB002EDE18)
Overview
- Phase
- Phase 4
- Intervention
- RFB002
- Conditions
- Retinal Vein Occlusion
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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).
Investigators
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
- •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)
Arms & Interventions
Ranibizumab (Arm A)
The PRN injection scheme applied in the core study will also be followed during this extension study: Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month
Intervention: RFB002
Dexamethasone (Arm B)
A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.
Intervention: Dexamethasone
Outcomes
Primary Outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 months
The number of participants who experienced Adverse events, serious AE and death
Secondary Outcomes
- Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group(Baseline, 6 months and 12 months)
- Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline(12 month)
- Change in Central Subfield Thickness (CSRT) From Baseline to Month 12(Baseline , Month 12)
- Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12(Baseline, Month 12)
- Change in Mean Visual Function Questionnaire (VFQ-25)(Baseline, 12 months)
- Change in SF-36 Summary Scores(Baseline, month 12)
- Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores(Baseline, month 12)
- Time to the First Retreatment of Both Treatment Arms(6 months)