NSAIDs and PGE2 Levels in Vitrectomy Patients

NCT02361645 | Completed Phase 3

• 1 other identifier: Vitreo001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before vitrectomy. A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. Samples were immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. The minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (R \& D Systems, Minneapolis, MN).

Conditions

Vitreous Inflammation

Keywords

nonsteroidal antiinflammatory drugs; prostaglandin E2; vitrectomy

Outcome Measures

Primary Outcomes (1)

• Prostaglandin E2 levels in the vitreous (pg/mL)

  7 days after NSAID TID administration, following vitrectomy

Secondary Outcomes (2)

• NSAIDs concentration (ng/mL) into the vitreous

  7 days after NSAID TID administration, following vitrectomy

• Adverse events

  7 days after NSAID TID administration, following vitrectomy

Study Arms (5)

Control Group

NO INTERVENTION

No NSAIDs were administered prior to surgery

Ketorolac eyedrops

EXPERIMENTAL

Ketorolac 0.5% eyedrops were administered prior to surgery

Drug: Ketorolac 0.5% eyedrops

Indomethacin eyedrops

EXPERIMENTAL

Indomethacin 0.5% eyedrops were administered prior to surgery

Drug: Indomethacin 0.5% eyedrops

Nepafenac eyedrops

EXPERIMENTAL

Nepafenac 0.1% eyedrops were administered prior to surgery

Drug: Nepafenac 0.1% eyedrops

Bromfenac eyedrops

EXPERIMENTAL

Bromfenac 0.09% eyedrops were administered prior to surgery

Drug: Bromfenac 0.09% eyedrops

Interventions

Ketorolac 0.5% eyedrops DRUG

Ketorolac eyedrops

Indomethacin 0.5% eyedrops DRUG

Indomethacin eyedrops

Bromfenac 0.09% eyedrops DRUG

Bromfenac eyedrops

Nepafenac 0.1% eyedrops DRUG

Nepafenac eyedrops

Eligibility Criteria

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

You may qualify if:

• patients with pucker scheduled for vitrectomy

You may not qualify if:

• diabetes
• active inflammation

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Related Publications (1)

• Morescalchi F, Russo A, Semeraro F. SURGICAL OUTCOMES OF VITREOMACULAR TRACTION TREATED WITH FOVEAL-SPARING PEELING OF THE INTERNAL LIMITING MEMBRANE. Retina. 2021 Oct 1;41(10):2026-2034. doi: 10.1097/IAE.0000000000003139.

  PMID: 33595256 DERIVED

MeSH Terms

Interventions

Ketorolac; Ophthalmic Solutions; Indomethacin; bromfenac; nepafenac

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 12, 2015
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 12, 2015

Record last verified: 2015-02