Phase 4
Completed N=175
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
Source: ClinicalTrials.gov NCT01580020 ↗Enrolled (actual)
175
Serious AEs
6.9%
Results posted
May 2016
Primary outcomePrimary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 35; 28; 45; 16 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
35; 28; 45; 16; 2; 3 | — |
| SECONDARY Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group |
56.8; 58.3; 53.8; 53.2; 77.9; 69.2 | — |
| SECONDARY Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline |
80.8; 50.0; 58.3; 45.5; 88.5; 65.0 | — |
| SECONDARY Change in Central Subfield Thickness (CSRT) From Baseline to Month 12 |
-288.1; -211.5; -374.6; -360.3 | — |
| SECONDARY Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12 |
-341.8; -252.6; -439.4; -432.3 | — |
| SECONDARY Change in Mean Visual Function Questionnaire (VFQ-25) |
8.1; 5.5; 9.1; 10.0; -1.4; 6.3 | — |
| SECONDARY Change in SF-36 Summary Scores |
1.6; 0.2; -1.1; 1.3; 3.3; 2.1 | — |
| SECONDARY Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores |
3.3; 2.6; 1.5; 0.2 | — |
| SECONDARY Time to the First Retreatment of Both Treatment Arms |
37; NA; 62; NA | — |
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 5 mIU/mL)
- who were menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index 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)
Data sourced from ClinicalTrials.gov (NCT01580020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.