Back to results

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

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

palmitoylethanolamide (PEA) 600 mg

About this trial

This is an interventional prevention trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

standard of care+palmitoylethanolamide

standard of care

Arm Description

PEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med)

patients were only on topical IOP lowering therapy (SOC)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess effects of PEA 600 mg on intraocular pressure (IOP) values

IOP measure in mmHg

To record visual field changes

changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters

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)

Full Information

NCT ID

NCT04088084

First Posted

September 6, 2019

Last Updated

September 10, 2019

Sponsor

IRCCS Policlinico S. Matteo

1. Study Identification

Unique Protocol Identification Number

NCT04088084

Brief Title

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

Official Title

Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 9, 2015 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Policlinico S. Matteo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.

Masking

InvestigatorOutcomes Assessor

Masking Description

examiners were blinded to the assumption or not of PEA in addition to topical therapy

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard of care+palmitoylethanolamide

Arm Type

Experimental

Arm Description

PEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med)

Arm Title

standard of care

Arm Type

No Intervention

Arm Description

patients were only on topical IOP lowering therapy (SOC)

Intervention Type

Dietary Supplement

Intervention Name(s)

palmitoylethanolamide (PEA) 600 mg

Intervention Description

PEA 600 mg was added to topical therapy

Primary Outcome Measure Information:

Title

To assess effects of PEA 600 mg a tablet a day on pattern electroretinogram PERG examination at three months of therapy.

Description

changes in amplitude (microVolt) and changes in latency (millisecond) of p50 and n95 waves

Time Frame

3 months

Secondary Outcome Measure Information:

Title

To assess effects of PEA 600 mg on intraocular pressure (IOP) values

Description

IOP measure in mmHg

Time Frame

3 months

Title

To record visual field changes

Description

changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters

Time Frame

3 months

Title

To follow quality of life - QL - perception using the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25)

Description

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)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

gemma caterina maria rossi, md

Organizational Affiliation

clinica oculistica

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

data will be published on peer review journal

IPD Sharing Time Frame

upon publication

IPD Sharing Access Criteria

actually not available

Learn more about this trial

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

We'll reach out to this number within 24 hrs