Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT01580020
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01580020
Study Brief:
Protocol Section:
NCT01580020