CompletedPhase 3

Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

Spain66 participantsStarted 2012-10

Plain-language summary

The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period

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: * Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography * Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria) * No atrophy or fibrotic component that may prevent visual acuity improvement * Patients previously treated with Photodynamic Therapy are allowed to participate in this study * Signed informed consent * Signed data protection consent * Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study Exclusion Criteria: * Previous vitreous surgery in study eye * Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography * Media opacities that may prevent correct fundus assessment * Lack of posterior capsule integrity in pseudophakic patients * Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria) * Patients previously treated with intravitreal antiangiogenic injections

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

Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity

Timeframe: 1 Year

Retinal thickness

Timeframe: 1 Year

Number of total injections during study

Timeframe: 1 Year

Trial details

NCT IDNCT01716026

SponsorInstituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

View on ClinicalTrials.gov More Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia trials

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.