A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in P… (NCT02034006) | Clinical Trial Compass
CompletedPhase 3
A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.
Italy200 participantsStarted 2014-06-10
Plain-language summary
The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage
Timeframe: Screening, Month 2, Month 6
2
Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema
Timeframe: Screening, Month 2, Month 6, Month 12
3
Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts
Timeframe: Screening, Month 2, Month 6, Month 12
4
Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid
Timeframe: Screening, Month 2, Month 6, Month 12
5
Change in Central Subfield Thickness (CSFT)
Timeframe: Screening, Month 2, Month 6, Month 12
6
Change in Central Subfield Volume (CSV)
Timeframe: Screening, Month 2, Month 6, Month 12
7
Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid