Clinical trial NCT01580020: Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Vein Occlusion
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group
timeFrame: Baseline, 6 months and 12 months
measure: Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline
timeFrame: 12 month
measure: Change in Central Subfield Thickness (CSRT) From Baseline to Month 12
timeFrame: Baseline , Month 12
measure: Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Mean Visual Function Questionnaire (VFQ-25)
timeFrame: Baseline, 12 months
measure: Change in SF-36 Summary Scores
timeFrame: Baseline, month 12
measure: Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores
timeFrame: Baseline, month 12
measure: Time to the First Retreatment of Both Treatment Arms
timeFrame: 6 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Rothenfelde
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg i. Br
country: Germany
facility: Novartis Investigative Site
city: Glauchau
country: Germany
facility: Novartis Investigative Site
city: Göttingen
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Ingolstadt
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Muelheim
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Recklinghausen
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Sulzbach
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: