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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT02034006
Eligibility Criteria:
INCLUSION CRITERIA:
* Written informed consent given before any study related procedure is performed
* Diagnosis of active CNV secondary to PM confirmed by complete ocular examination in the affected eye(s) using the following criteria:
* Presence of high myopia greater than -6D of spherical equivalence
* Presence of posterior changes compatible with pathologic myopia (any signs of attenuation of retinal pigment epithelium (RPE) and choroids, mottling of the RPE, tilted disc, geographic atrophy of RPE, Fuchs spots, posterior staphyloma, submacular hemorrhage, lacquer cracks) detected by fundus ophthalmoscopy and fundus photography
* Presence of active leakage from CNV observed through fluorescein angiography (FAG)
* Presence of intra or subretinal fluid demonstrated by Optical Coherence Tomography (OCT)
* BCVA \> 24 letters and \< 78 letters tested at 4 meters staring distance using ETDRS-like visual acuity chart
* Visual loss must be only due to the presence of any eligible types of CNV related to PM based on clinical ocular findings, FAG and OCT. (Also patients that have for example 20/60 as their best visual acuity due to PM in their history and have additional vision loss due to CNV lesion can be included)
EXCLUSION CRITERIA:
* Patients with inability to comply with study related procedures
* Pregnant or nursing (lactating) women and women of childbearing potential UNLESS using effective contraception during treatment
* Presence of confirmed systolic blood pressure \> 150 mmHg or diastolic \> 90 mmHg at the time of enrollment
* History of stroke
* Any type of advanced, severe or unstable medical condition or its treatment that could significantly bias the assessment of clinical status and interfere with primary and/or secondary outcome evaluations or put the patient at risk
* Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrollment
* Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (including retinal detachment, cataract and pre-retinal membrane of the macula)
* History of pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time
* History of intraocular treatment with any anti-vascular endothelial growth factor (VEGF), verteporfin photodynamic therapy (vPDT) and any intra-ocular surgery or corticosteroid administration within one month before study entrance
* Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
* Simultaneous participation in a study that includes administration of any investigational drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02034006
Study Brief:
Protocol Section:
NCT02034006