We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088084
Recruitment Status : Completed
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Rossi, Gemma Caterina Maria, IRCCS Policlinico S. Matteo

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)


Condition or disease Intervention/treatment Phase
Glaucoma Dietary Supplement: palmitoylethanolamide (PEA) 600 mg Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: examiners were blinded to the assumption or not of PEA in addition to topical therapy
Primary Purpose: Prevention
Official Title: Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.
Actual Study Start Date : March 9, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To assess effects of PEA 600 mg on intraocular pressure (IOP) values [ Time Frame: 3 months ]
    IOP measure in mmHg

  2. To record visual field changes [ Time Frame: 3 months ]
    changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters

  3. To follow quality of life - QL - perception using the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) [ Time Frame: 3 months ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088084


Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Layout table for investigator information
Principal Investigator: gemma caterina maria rossi, md clinica oculistica
  Study Documents (Full-Text)

Documents provided by Rossi, Gemma Caterina Maria, IRCCS Policlinico S. Matteo:
Layout table for additonal information
Responsible Party: Rossi, Gemma Caterina Maria, principal investigator, clinical ophthalmologist, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT04088084    
Other Study ID Numbers: PEA2015
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data will be published on peer review journal
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: upon publication
Access Criteria: actually not available

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases
Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists