Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents and Age Related Macular Degeneration… (NCT02557451) | Clinical Trial Compass
CompletedNot Applicable
Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents and Age Related Macular Degeneration Complications
France91 participantsStarted 2016-04-28
Plain-language summary
AMD is a disease of the central retina, a zone that enables fine detail activities (reading, detail…). This central zone of the retina can be affected by a haemorrhagic complication when small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic approaches are currently available even though they have never been truly compared. The study will be proposed to patients who need to be treated for haemorrhage of the macula. A certain number of factors will be evaluated to compare the 2 principal approaches currently used in France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled trial to compare these 2 therapeutic approaches.
These diametrically opposed approaches have very different consequences for patients and in terms of cost for society. The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life, while taking into account the risks inherent to these 2 treatments. The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease, which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas.
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:
Patients presenting subretinal haematoma linked to AMD
* Occurring at least14 days before the start of therapy
* With the presence of a component overlying the pigmentary epithelium (PE) on the OCT
* And a diameter greater than two pupillary diameters on the retinal photographs
Patients who have provided oral consent
Patients with National Health Insurance cover
Patients available for monthly follow-up
Patient having an effective contraception for the women old enough to procreate during the treatment and during 6 months which follow his stop.
Exclusion Criteria:
* Subretinal haematoma linked to a cause other than AMD (myopia, angioid streaks…)
* History of subretinal haematoma on the same side
* Cloudy humour making it impossible to photograph the fundus of the eye or carry out angiography
* Component of the haematoma exclusively underlying the pigmentry epithelium
* Haemorrhage without lifting of the retina
* Patients presenting an INR greater than 4, thus contra-indicating surgery
* Patients requiring cataract surgery in the first 3 months of the study
* Patients presenting a contra-indication relative to injection of the antiangiogenic (History of AVC bleeding or unknown origin in the last 6 months or MI in the 3 preceding months)
* Pregnant or breast-feeding woman (the patients do not have to breast-feed during at least 6 months after the administration of the last dose of the antiangiogénique)
* Contraindication in the use of ranibizumab: hyp…
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.