PGE2 Levels in Patient Treated With NSAIDs

Phase 3

Completed

• Conditions: Ocular Inflammation
• Interventions: Drug: Indom; Other: Placebo; Drug: Dicloftil; Drug: Nevanac; Drug: Yellox

• Registration Number: NCT03597867
• Lead Sponsor: University of Trieste

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-25
• Status Verified: 2018-07
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-09
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-21
• Last Update Submitted: 2018-07-21
• Study First Posted: 2018-07-24
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indom	Indom	Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery
Placebo	Placebo	Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
Dicloftil	Dicloftil	Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery
Nevanac	Nevanac	Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery
Yellox	Yellox	Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery

Primary Outcome Measures

Name	Time	Method
Vitreous NSAIDs and PGE2 levels	3 days after topical NSAID administration

Trial Locations

Locations (1)

Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste; 🇮🇹 Trieste, TS, Italy