Effects of Palmitoylethanolamide on Inner Retinal Function in Glaucoma Patients by Pattern Electroretinogram

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)

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Dietary supplement: palmitoylethanolamide (PEA) 600 mg

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• -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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard of care+palmitoylethanolamide; PEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med)	Dietary supplement: palmitoylethanolamide (PEA) 600 mg; PEA 600 mg was added to topical therapy
No Intervention: standard of care; patients were only on topical IOP lowering therapy (SOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess effects of PEA 600 mg on intraocular pressure (IOP) values	IOP measure in mmHg	3 months
To record visual field changes	changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters	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)	3 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: gemma caterina maria rossi, md, Clinica Oculistica

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Palmidrol
• Other Study ID Numbers: PEA2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: data will be published on peer review journal
• IPD Sharing Time Frame: upon publication
• IPD Sharing Access Criteria: actually not available
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No