Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of… (NCT02707120) | Clinical Trial Compass
WithdrawnPhase 4
Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis
Stopped: The study was suspended due to recruitment difficulties
Spain0Started 2018-01-04
Plain-language summary
Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the regeneration deterioration and development of corneal ulceration, their fusion, and perforation The main characteristic in the NK is a decrease or absence of corneal sensitivity.
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:
* Patients aged 18 or over.
* With neurotrophic keratitis at stages 2 or 3 affecting only one eye.
* Persistent epithelial defect or corneal ulcer of at least 2 weeks duration resistant to one or more traditional non-surgical treatments .
* Corneal sensitivity reduction test in the area of the persistent epithelial defect or corneal ulcer and out of the defect area in at least one corneal quadrant.
* No objective clinical evidence of improvement in the two weeks prior to enrollment.
* Patients who have previously read and signed the informed consent.
Exclusion Criteria:
* Patients with neurotrophic keratitis stages 2 or 3 that affects both eyes.
* With active ocular infection or inflammation not related to the neurotrophic keratitis
* Any other eye disease that requires of topical ocular treatment in the affected eye during study.
* Patients with severe vision loss
* Patients with severe blepharitis and/or severe Meibomian glands disease
* History of eye surgery in the three months prior to enter the study, or patients who plan to undergo surgery.
* Having received previously surgical procedures for the treatment of NK.
* Use of therapeutic contact lenses or for refractive correction during study.
* Patients with punctual occlusion or insertion of punctual plugs previous to the study
* Evidence of corneal ulcer affecting the corneal stroma or cornea perforation.
* Presence of any disorder or ocular or systemic disease that could limit the treatment effe…
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
1
Percentage of patients with a reduction of corneal defect of >50%