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

NCT04088084 | Completed Phase 2 DMC

• 1 other identifier: PEA2015
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  3 months

• To record visual field changes

  3 months

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

  3 months

Study Arms (2)

standard of care+palmitoylethanolamide

EXPERIMENTAL

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

Dietary Supplement: palmitoylethanolamide (PEA) 600 mg

standard of care

NO INTERVENTION

patients were only on topical IOP lowering therapy (SOC)

Interventions

palmitoylethanolamide (PEA) 600 mg DIETARY_SUPPLEMENT

PEA 600 mg was added to topical therapy

standard of care+palmitoylethanolamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

MeSH Terms

Conditions

Glaucoma

Interventions

palmidrol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• gemma caterina maria rossi, md

  clinica oculistica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: examiners were blinded to the assumption or not of PEA in addition to topical therapy
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, clinical ophthalmologist

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

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 12, 2019
• Study Start: March 9, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: upon publication
• Access Criteria: actually not available