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NSAIDs and PGE2 Levels in Vitrectomy Patients

Information source: UniversitÓ degli Studi di Brescia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitreous Inflammation

Intervention: Ketorolac 0.5% eyedrops (Drug); Indomethacin 0.5% eyedrops (Drug); Bromfenac 0.09% eyedrops (Drug); Nepafenac 0.1% eyedrops (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UniversitÓ degli Studi di Brescia


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).

Clinical Details

Official title: Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Prostaglandin E2 levels in the vitreous (pg/mL)

Secondary outcome:

NSAIDs concentration (ng/mL) into the vitreous

Adverse events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- patients with pucker scheduled for vitrectomy

Exclusion Criteria:

- diabetes

- active inflammation

Locations and Contacts

Additional Information

Starting date: March 2014
Last updated: February 6, 2015

Page last updated: August 23, 2015

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