Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD (NCT04676854) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD
France, Germany, Italy38 participantsStarted 2020-11-24
Plain-language summary
The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).
Who can participate
Age range
60 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:
* Is 60 years or older at the date of inclusion;
* Has a confirmed diagnosis of geographic atrophy due to AMD in both eyes;
* The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test;
* Has an atrophic patch in the study eye including the fovea of at least the implant size (\>4.5 mm2 and \>2.4 mm in minimum diameter);
* Understands the constraints of the study and accepts to present for all scheduled follow-up visits;
* Patient signed informed consent
Exclusion Criteria:
* Has cataract in the study eye (with LOCS III scale NO, NC, C or P\>1); (these patients will be asked to have cataract surgery performed prior to enrollment; all other patients will get IOL replacement during the PRIMA implantation);
* Underwent intra ocular lens implantation in the study eye within the last month ;
* Has a highly myopic study eye (\>26 mm AP);
* Has a highly hyperopic study eye (\<20 mm AP);
* Has no light perception in either eye;
* Has a history of documented choroidal neovascularization in either eye;
* Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye;
* Has an implanted telescope in one eye;
* Has a black IOL in the study eye;
* Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye or the visual system (e.g., central retinal artery/vein occlusion, end-stage diabeti…
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.
1This trial is testing an implanted device called the PRIMA system for geographic atrophy — given that it involves surgery to place something in my eye, what are the most serious risks my doctor would want me to understand before even considering this?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — is there any way to access the PRIMA system outside of this trial, or are there similar studies still open that I might be eligible for?
3One of the main things this trial is measuring is 'meaningful improvement of visual acuity' — how is that defined in practice, and would the potential improvement be significant enough to change my daily life given where my vision is right now?
4Since this is a device implant study listed under Phase NA rather than a traditional drug trial phase, what does that mean for how much is already known about long-term safety and whether the benefits outweigh the risks?
5Before pursuing something like a surgical implant, should I first discuss whether any currently approved treatments or lower-risk interventions for geographic atrophy might be worth trying in my situation?
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
1
Proportion of subjects with meaningful improvement of visual acuity