Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections V… (NCT01580020) | Clinical Trial Compass
CompletedPhase 4
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
Germany175 participantsStarted 2012-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 bilater…
What they're measuring
1
Number of Participants With Adverse Events as a Measure of Safety and Tolerability