CompletedNot Applicable

Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

France100 participantsStarted 2018-11-26

Plain-language summary

Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines. The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

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: * Age \> 18 years * Diagnosis of exudative age-related macular degeneration requiring intravitreal anti-VEGF treatment. * Patient for whom the last intravitreal injection of anti-VEGF in the eye is strictly more than 3 months * Signature of informed consent * Affiliation to the French social security system Exclusion Criteria: * Pregnant or nursing patient (a urinary pregnancy test will be performed) * Systemic treatment with anti-VEGF * Intravitreal treatment with anti-VEGF for less than 3 months regardless of the treated eye. * Retinal pathology that can modify the secretion of pro-inflammatory cytokines such as diabetic retinopathy, venous occlusions, intermediate and posterior uveitis. * Diabetes Mellitus * High Myopia * Simultaneous participation in another clinical research protocol in exudative AMD * Person under guardianship, under curatorship, deprived of liberty

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

Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months

Timeframe: At Month 3

Trial details

NCT IDNCT03630562

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-12

View on ClinicalTrials.gov More Age Related Macular Degeneration trials