GlaucomaPhase 2NCT04088084
Effects of Palmitoylethanolamide on Inner Retinal Function in Glaucoma Patients by Pattern Electroretinogram
A Phase 2 study testing palmitoylethanolamide (PEA) 600 mg in people with Glaucoma, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial summary
The general purpose of the study is to evaluate the potential beneficial effects of PEA 600 mg supplementation on RGCs function in subjects with glaucoma by pattern electroretinogram after three months of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- palmitoylethanolamide (PEA) 600 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2015to 31 Dec 2017
- Phase
- Phase 2
- 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
- -age 18 years or older
- diagnosis of primary open angle glaucoma (POAG)
- controlled IOP (<18 mmHg, morning value) with any topical lowering medication (beta-blockers, carbonic anhidrase inhibitors, alpha2agonists, prostaglandin analogues as monotherapy or as associative therapy; betablocker/carbonic anhydrase inhibitor, betablocker/alpha2agonist, prostaglandine/betablocker and alpha2agonist/carbonic anhidrase inhibitor fixed combinations as monotherapy or in association);
- stable IOP<18 mmHg in the last 2 years
- stable disease in the last 2 years (no more than -1 deciBell-dB/year at MD of visual field)
- at least two reliable visual fields per year in the last 2 years
- no filtering surgery or other ocular surgery in the preceding 6 months
- written consent to participate to study procedures and data utilization in an anonymous form
Who cannot join
- ocular hypertension with normal optic nerve and visual field
- contraindication to PEA
- glaucomatous scotomas within 10 degree from fixation
- any condition limiting the patient's ability to participate in the study;
- other causes of visual field changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion
About this study
Official title: Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.
The general purpose of the study is to evaluate the potential beneficial effects of PEA 600 mg supplementation on RGCs function in subjects with glaucoma by pattern electroretinogram after three months of therapy.
Secondary objectives are to assess effects on intraocular pressure (IOP) values, if any; to record visual acuity, visual field, central corneal thickness (CCT), and Optical coherence tomography (OCT) (ganglion cell complex - GCC) changes, if any and to follow quality of life (QL) perception (general vision -GV and general health - GH of national eye instutute visual functioning questionnaire 25 items - NEI VFQ25)
Read the detailed description
Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
The investigators have proposed a cross-over trial to avoid or to detect the bias due to intra-individual variability and because, from preliminary observation, it has been noted that the effects of PEA on pattern-electroretinogram (PERG) are completely reversible after withdrawal, within one month.
The investigators didn't considered a placebo treated group because the patient cannot interfere with the pattern-electroretinogram PERG measurement that is objective and totally patient-independent.
Study duration 12 months Enrolment period 6 months Minimum Follow-up 6 months Start: January, 2015; end January, 2016 Total sample size: 40 patients
- Conditions
- Glaucoma
- Being tested
- palmitoylethanolamide (PEA) 600 mg
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palmitoylethanolamide (PEA) 600 mgDietary supplement
PEA 600 mg was added to topical therapy
| Study group | Role | What they receive |
|---|---|---|
| standard of care+palmitoylethanolamide | Experimental | PEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med) Receives: Dietary Supplement: palmitoylethanolamide (PEA) 600 mg |
| standard of care | No intervention | patients were only on topical IOP lowering therapy (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess effects of PEA 600 mg a tablet a day on pattern electroretinogram PERG examination at three months of therapy.
changes in amplitude (microVolt) and changes in latency (millisecond) of p50 and n95 waves
Measured: 3 months
Secondary outcomes (3)
To assess effects of PEA 600 mg on intraocular pressure (IOP) values
IOP measure in mmHg
Measured: 3 months
To record visual field changes
changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters
Measured: 3 months
To follow quality of life - QL - perception using the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25)
changes in the total mean score, in the General vision -GV- and in the general health -GH- subscales scores (scores are presented as a number, higher numbers reflect higher QL)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start9 Mar 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossi, Gemma Caterina Maria, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- gemma caterina maria rossi, md, Principal investigator, clinica oculistica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088084
- Sponsor's protocol ID
- PEA2015
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be published on peer review journal
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.
- ClinicalTrials.gov ID
- NCT04088084
- Acronym / sponsor ID
- PEA2015
- Conditions
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Sep 2019 (actual)
- 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.
The general purpose of the study is to evaluate the potential beneficial effects of PEA 600 mg supplementation on RGCs function in subjects with glaucoma by pattern electroretinogram after three months of therapy.
Secondary objectives are to assess effects on intraocular pressure (IOP) values, if any; to record visual acuity, visual field, central corneal thickness (CCT), and Optical coherence tomography (OCT) (ganglion cell complex - GCC) changes, if any and to follow quality of life (QL) perception (general vision -GV and general health - GH of national eye instutute visual functioning questionnaire 25 items - NEI VFQ25)
Detailed description
Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
The investigators have proposed a cross-over trial to avoid or to detect the bias due to intra-individual variability and because, from preliminary observation, it has been noted that the effects of PEA on pattern-electroretinogram (PERG) are completely reversible after withdrawal, within one month.
The investigators didn't considered a placebo treated group because the patient cannot interfere with the pattern-electroretinogram PERG measurement that is objective and totally patient-independent.
Study duration 12 months Enrolment period 6 months Minimum Follow-up 6 months Start: January, 2015; end January, 2016 Total sample size: 40 patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
| Arm | Type | Receives |
|---|---|---|
| standard of care+palmitoylethanolamide | Experimental | Dietary Supplement: palmitoylethanolamide (PEA) 600 mgPEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med) |
| standard of care | No intervention | –patients were only on topical IOP lowering therapy (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -age 18 years or older
- diagnosis of primary open angle glaucoma (POAG)
- controlled IOP (<18 mmHg, morning value) with any topical lowering medication (beta-blockers, carbonic anhidrase inhibitors, alpha2agonists, prostaglandin analogues as monotherapy or as associative therapy; betablocker/carbonic anhydrase inhibitor, betablocker/alpha2agonist, prostaglandine/betablocker and alpha2agonist/carbonic anhidrase inhibitor fixed combinations as monotherapy or in association);
- stable IOP<18 mmHg in the last 2 years
- stable disease in the last 2 years (no more than -1 deciBell-dB/year at MD of visual field)
Key exclusion criteria (5 listed)
- ocular hypertension with normal optic nerve and visual field
- contraindication to PEA
- glaucomatous scotomas within 10 degree from fixation
- any condition limiting the patient's ability to participate in the study;
- other causes of visual field changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion
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 |
|---|---|---|
| palmitoylethanolamide (PEA) 600 mgPEA 600 mg was added to topical therapy | Dietary supplement | standard of care+palmitoylethanolamide |
Primary outcome
To assess effects of PEA 600 mg a tablet a day on pattern electroretinogram PERG examination at three months of therapy.
Time frame: 3 months
changes in amplitude (microVolt) and changes in latency (millisecond) of p50 and n95 waves
3 secondary outcomes
To assess effects of PEA 600 mg on intraocular pressure (IOP) values
Time frame: 3 months
To record visual field changes
Time frame: 3 months
To follow quality of life - QL - perception using the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: Yes. data will be published on peer review journal
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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.
gemma caterina maria rossi, md principal investigator
clinica oculistica
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing palmitoylethanolamide (PEA) 600 mg in people with Glaucoma, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess effects of PEA 600 mg a tablet a day on pattern electroretinogram PERG examination at three months of therapy. (time frame: 3 months). 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 12 Sep 2019.