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PGE2 Levels in Patient Treated With NSAIDs

Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03597867
Enrollment
104
Registered
2018-07-24
Start date
2018-04-25
Completion date
2018-07-09
Last updated
2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Inflammation

Keywords

vitreoretinal surgery, epiretinal membrane, macular hole, non steroidal antinflammatory drugs, prostaglandin E2

Brief summary

The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy. All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis. Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL. PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.

Interventions

OTHERPlacebo

Artificial tears for 3 days preoperatively

DRUGDicloftil

Dosing of drug 3 days prior to surgery

Dosing of drug 3 days prior to surgery

DRUGIndom

Dosing of drug 3 days prior to surgery

DRUGYellox

Dosing of drug 3 days prior to surgery

Sponsors

University of Trieste
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* epiretinal membrane or full thickness macular hole scheduled for vitrectomy

Exclusion criteria

* vitreous hemorrhage * diabetes * glaucoma * concurrent retinovascular disease * previous ocular inflammation * previous ocular surgery * history of ocular trauma * previuos intravitreal injections * concomitant intake of topical or systemic NSAIDs or corticosteroid therapy

Design outcomes

Primary

MeasureTime frame
Vitreous NSAIDs and PGE2 levels3 days after topical NSAID administration

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026