NCT03597867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

July 11, 2018

Last Update Submit

July 21, 2018

Conditions

Ocular Inflammation

Keywords

vitreoretinal surgeryepiretinal membranemacular holenon steroidal antinflammatory drugsprostaglandin E2

Outcome Measures

Primary Outcomes (1)

  • Vitreous NSAIDs and PGE2 levels

    3 days after topical NSAID administration

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.

Other: Placebo

Dicloftil

EXPERIMENTAL

Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery

Drug: Dicloftil

Nevanac

EXPERIMENTAL

Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery

Drug: Nevanac

Indom

EXPERIMENTAL

Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery

Drug: Indom

Yellox

EXPERIMENTAL

Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery

Drug: Yellox

Interventions

PlaceboOTHER

Artificial tears for 3 days preoperatively

Also known as: Tears
Placebo
DicloftilDRUG

Dosing of drug 3 days prior to surgery

Also known as: Diclofenac Na 0.1% Oph Soln
Dicloftil
NevanacDRUG

Dosing of drug 3 days prior to surgery

Also known as: Nepafenac 0.3% Ophthalmic Suspension
Nevanac
IndomDRUG

Dosing of drug 3 days prior to surgery

Also known as: Indomethacin 5 MG/ML Ophthalmic Suspension
Indom
YelloxDRUG

Dosing of drug 3 days prior to surgery

Also known as: Bromfenac 0.09 % Ophthalmic Solution
Yellox

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • epiretinal membrane or full thickness macular hole scheduled for vitrectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste

Trieste, TS, 34129, Italy

Location

MeSH Terms

Conditions

Epiretinal MembraneRetinal Perforations

Interventions

nepafenacIndomethacinbromfenacOphthalmic Solutions

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Marco R Pastore, MD

    Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 24, 2018

Study Start

April 25, 2018

Primary Completion

July 5, 2018

Study Completion

July 9, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)