Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovas… (NCT01835067) | Clinical Trial Compass
CompletedPhase 2/3
Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovascular AMD
United Kingdom55 participantsStarted 2014-09
Plain-language summary
This study will recruit patients who have recently had a submacular haemorrhage (bleed under the part of the retina responsible for detailed vision), as a complication of wet age-related macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal blood vessels form under the retina and leak, causing a significant reduction in vision.
The study will investigate treatment of the bleed with various combinations of the two drugs: tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke. C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four groups: control group that receive none of the above drugs; one group that receives only tPA; one group that receives only C3F8; and one group that receives both.
All patients will receive the current gold standard treatment for wet AMD, ranibizumab (Lucentis®).
The aim of the study is to improve vision in a condition, which left untreated, would cause severe visual loss.
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:
* Adults of either sex aged 50 years and older;
* SMH associated with treatment-naive or previously treated wet AMD, including retinal angiomatous proliferation (RAP) and idiopathic polypoidal choroidal vasculopathy (IPCV);
* SMH of at least 1 disc area, involving the fovea, and of sufficient density to obscure RPE detail;
* Written informed consent to participate in the study.Only one eye will be eligible for inclusion in this study.
Exclusion criteria:
* SMH that is known to have been present for greater than 2 weeks duration, as evidenced by history, pre-trial documentation, or fundus appearance;
* Presence of significant vitreous haemorrhage precluding accurate retinal assessment in the study eye;
* Diabetic maculopathy in the study eye;
* Visually significant cataract in the study eye;
* Amblyopia in the study eye;
* Presence of other ocular disease causing concurrent vision loss in the study eye;
* Advanced glaucoma in the study eye (cup-to-disc ratio greater than 0.8);
* Pregnant and or lactating women;
* Women of childbearing potential including those who are not sterilised or at least one year post menopausal;
* Participation in a clinical interventional trial in the preceding 6 months;
* Documented evidence of a visual acuity less than 25 ETDRS letters at three consecutive visits in the study eye, prior to the onset of submacular haemorrhage;
* Participants who are known to have been ineligible for NICE approved ranibizumab therapy prior to th…
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.