A Phase 4 interventional study of PRGF-Endoret and Artificial tears eye-drops in Neurotrophic Keratitis, sponsored by Biotechnology Institute IMASD. Withdrawn at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Biotechnology Institute IMASD · Phase 4, Interventional, and Treatment
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.
The goals of treatment in the neurotrophic keratitis are prevent the progression of corneal damage, maintain eye structure and improve the transparency of the cornea. Therapy should be initiated early and based on the clinical stage of the disease because it depends on epithelial state and in the degree of corneal hypoesthesia.
Plasma rich in growth factors (PRGF-Endoret) represent a new technology using autologous proteins, growth factors and biomaterials as therapeutic formulations for different regenerative purposes. Under strict pharmaceutical development, it is possible to develop biologically stable eye drops, which have been shown to be useful for treating diverse ocular surface diseases. PRGF-Endoret eye drops could be an alternative therapy for patients with NK, and thus the objective of this clinical trial is to demonstrate its possible efficacy and its safety in patients with NK in stages 2 and 3.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
Browse Keratitis studies →Biotechnology Institute IMASD is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: PRGF-Endoret
Drug: Artificial tears eye-drops
Active treatment will be PRP eye drops obtained by the PRGF-Endoret system.
Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives).
Percentage of patients with a reduction of corneal defect of >50%
Time frame: 4 weeks
Percentage of patients with a reduction of corneal defect of >50%
Time frame: 2 weeks
Percentage of patients showing complete healing of the corneal defect
Time frame: 4 weeks
Percentage of patients showing complete healing of the corneal defect
Time frame: 2 weeks
Measurement of the depth of the corneal defect (mm)
Time frame: 2 and 4 weeks
Changes in percentage in Best corrected visual acuity (BCVA LogMAR)
Time frame: 2 and 4 weeks
Ocular pain with VAS scale
Time frame: 2 and 4 weeks
Osmolarity of lacrimal film
Time frame: 2 and 4 weeks
Measurement of treatment tolerance
Measurement of treatment tolerance with a 0 4 score
Time frame: 2 and 4 weeks
Adverse events
Percentage of adverse event occurrence
Time frame: 2 and 4 weeks
This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Biotechnology Institute IMASD