Neurotrophic KeratitisPhase 4NCT02707120
Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis
A Phase 4 study testing PRGF-Endoret and Artificial tears eye-drops in people with Neurotrophic Keratitis, run by Biotechnology Institute IMASD at 4 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- PRGF-Endoret and Artificial tears eye-drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesSpain
- Study dates
- 4 Jan 2018to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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 effectiveness or its evaluation,
- Any need of change (at that time or planned) in the dose of systemic drugs known to disrupt the functioning of the trigeminal nerve
- Known hypersensitivity to any of the procedural compounds (eg. fluoresceine).
- Presence of blood disorders associated with platelet disorders or clotting, or receiving anticoagulants drugs or antiplatelet agents.
- Patients with positive result in one of the serological tests for syphilis, Hepatitis B-C or AIDS I / II.
- Patient in current treatment for their pathology already well managed.
- Use of any investigational drug within 4 weeks prior to the screening visit.
- Pregnant women or intended to be pregnant.
- Participating in another clinical trial.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Instituto de Microcirugía Ocular (IMO)
Barcelona
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
Bilbao, Bizkaia
Hospital Ramón y Cajal
Madrid
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias
About this study
Official title: Randomized, Parallel Groups, Multicenter and Blind to Evaluators Clinical Trial, to Evaluate the Efficacy and Safety of PRGF-Endoret Eye Drops, in Patients With Stage 2 and 3 Neurotrophic Keratitis
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.
Read the detailed description
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.
- Conditions
- Neurotrophic Keratitis
- Being tested
- PRGF-Endoret, Artificial tears eye-drops
- Keywords
- PRGF, Neurotrophic Keratitis, platelet rich plasma, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF-EndoretDrug
Active treatment will be PRP eye drops obtained by the PRGF-Endoret system.
Artificial tears eye-dropsDrug
Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives).
| Study group | Role | What they receive |
|---|---|---|
| PRGF-Endoret eye-drops | Experimental | Not described Receives: Drug: PRGF-Endoret |
| Artificial tears eye-drops | Active comparator | Not described Receives: Drug: Artificial tears eye-drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a reduction of corneal defect of >50%
Measured: 4 weeks
Secondary outcomes (9)
Percentage of patients with a reduction of corneal defect of >50%
Measured: 2 weeks
Percentage of patients showing complete healing of the corneal defect
Measured: 4 weeks
Percentage of patients showing complete healing of the corneal defect
Measured: 2 weeks
Measurement of the depth of the corneal defect (mm)
Measured: 2 and 4 weeks
Changes in percentage in Best corrected visual acuity (BCVA LogMAR)
Measured: 2 and 4 weeks
Ocular pain with VAS scale
Measured: 2 and 4 weeks
Osmolarity of lacrimal film
Measured: 2 and 4 weeks
Measurement of treatment tolerance
Measurement of treatment tolerance with a 0 4 score
Measured: 2 and 4 weeks
Adverse events
Percentage of adverse event occurrence
Measured: 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start4 Jan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: The study was suspended due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotechnology Institute IMASD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707120
- Sponsor's protocol ID
- BTI-011-EC/15/QUER
- Status last verified
- Feb 2025
- First submitted
- 29 Feb 2016
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel Groups, Multicenter and Blind to Evaluators Clinical Trial, to Evaluate the Efficacy and Safety of PRGF-Endoret Eye Drops, in Patients With Stage 2 and 3 Neurotrophic Keratitis
- ClinicalTrials.gov ID
- NCT02707120
- Acronym / sponsor ID
- BTI-011-EC/15/QUER
- Conditions
- Neurotrophic Keratitis
- Keywords
- PRGF, Neurotrophic Keratitis, platelet rich plasma, PRP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was suspended due to recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biotechnology Institute IMASDIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRGF-Endoret eye-drops | Experimental | Drug: PRGF-Endoret |
| Artificial tears eye-drops | Active comparator | Drug: Artificial tears eye-drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRGF-EndoretActive treatment will be PRP eye drops obtained by the PRGF-Endoret system. | Drug | PRGF-Endoret eye-drops |
| Artificial tears eye-dropsArtificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives). | Drug | Artificial tears eye-drops |
Primary outcome
Percentage of patients with a reduction of corneal defect of >50%
Time frame: 4 weeks
9 secondary outcomes
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
Time frame: 2 and 4 weeks
Adverse events
Time frame: 2 and 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
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RecruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRGF-Endoret and Artificial tears eye-drops in people with Neurotrophic Keratitis, run by Biotechnology Institute IMASD at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a reduction of corneal defect of >50% (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.