Brolucizumab for CNV Associated With Pathologic Myopia (NCT04976244) | Clinical Trial Compass
UnknownNot Applicable
Brolucizumab for CNV Associated With Pathologic Myopia
Ukraine50 participantsStarted 2021-04-01
Plain-language summary
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
Who can participate
Age range
18 Years – 80 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:
* Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent form or a family member) and understand the informed consent form and willing to sign the informed consent form.
* Signed informed consent form.
* Men and women ≥ 18 years of age.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Myopia of greater than or equal to -6 D OR axial length of greater than (if the spherical myopic equivalent is \<6.0 diopters, then the patient should have myopic changes in the macula: lacquer cracks, focal chorioretinal atrophy, posterior staphyloma) or equal to 26.5 mm.
* Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to pathologic myopia as defined by leakage on FA.
* Transparent optical media and possibility to mydriasis.
* Best corrected visual acuity at least 20/200 Equivalent of Snellen (ETDRS).
Exclusion Criteria:
* Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
* Recurrent mCNV in the study eye
* History or presence of CNV with an origin other than pathologic myopia in the study eye
* Ocular inflammation or external ocular inflammation in the study eye
* Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period
* Any ocular disorder in the study eye that, in the opinion of t…
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
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart
Timeframe: Baseline-Month 12
Trial details
NCT IDNCT04976244
SponsorThe Filatov Institute of Eye Diseases and Tissue Therapy