CompletedNot Applicable

Evaluate the Quality of Life of Patients With AMD

France28 participantsStarted 2017-08-08

Plain-language summary

Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.

Who can participate

Age range

50 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: \- For the 2 populations studied * Persons who have given consent to take part * Persons aged 50 years or older * Willing and able to attend all of the scheduled visits and evaluations * Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm * Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors * Diagnosed for less than 3 years * MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m For patients with secondary atrophic AMD • Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection. Exclusion Criteria: General criteria * Persons without national health insurance cover * Physical or mental disability ruling out participation * Inability to sign the written consent form, adults under guardianship * Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised). * Adults under guardianship General medical history • Uncontrolled AHT Ophthalmological history * Severe non-proliferative or proliferative diabetic retinopathy * Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery * Corneal disease that could impair vision * Monogen…

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

responses to a quality of life questionnaire

Timeframe: Change compared with baseline score at month 6, month 12 and month 18

Trial details

NCT IDNCT03242083

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-03

View on ClinicalTrials.gov More Age-related Macular Degeneration trials