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NSAIDs and PGE2 Levels in Vitrectomy Patients

Primary Purpose

Vitreous Inflammation

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ketorolac 0.5% eyedrops

Indomethacin 0.5% eyedrops

Bromfenac 0.09% eyedrops

Nepafenac 0.1% eyedrops

About this trial

This is an interventional treatment trial for Vitreous Inflammation focused on measuring nonsteroidal antiinflammatory drugs, prostaglandin E2, vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with pucker scheduled for vitrectomy

Exclusion Criteria:

diabetes
active inflammation

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Ketorolac eyedrops

Indomethacin eyedrops

Nepafenac eyedrops

Bromfenac eyedrops

Arm Description

No NSAIDs were administered prior to surgery

Ketorolac 0.5% eyedrops were administered prior to surgery

Indomethacin 0.5% eyedrops were administered prior to surgery

Nepafenac 0.1% eyedrops were administered prior to surgery

Bromfenac 0.09% eyedrops were administered prior to surgery

Outcomes

Primary Outcome Measures

Prostaglandin E2 levels in the vitreous (pg/mL)

Secondary Outcome Measures

NSAIDs concentration (ng/mL) into the vitreous

Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system.

Adverse events

Full Information

NCT ID

NCT02361645

First Posted

January 27, 2015

Last Updated

February 6, 2015

Sponsor

Università degli Studi di Brescia

1. Study Identification

Unique Protocol Identification Number

NCT02361645

Brief Title

NSAIDs and PGE2 Levels in Vitrectomy Patients

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 Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi di Brescia

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitreous Inflammation

Keywords

nonsteroidal antiinflammatory drugs, prostaglandin E2, vitrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

No NSAIDs were administered prior to surgery

Arm Title

Ketorolac eyedrops

Arm Type

Experimental

Arm Description

Ketorolac 0.5% eyedrops were administered prior to surgery

Arm Title

Indomethacin eyedrops

Arm Type

Experimental

Arm Description

Indomethacin 0.5% eyedrops were administered prior to surgery

Arm Title

Nepafenac eyedrops

Arm Type

Experimental

Arm Description

Nepafenac 0.1% eyedrops were administered prior to surgery

Arm Title

Bromfenac eyedrops

Arm Type

Experimental

Arm Description

Bromfenac 0.09% eyedrops were administered prior to surgery

Intervention Type

Drug

Intervention Name(s)

Ketorolac 0.5% eyedrops

Intervention Type

Drug

Intervention Name(s)

Indomethacin 0.5% eyedrops

Intervention Type

Drug

Intervention Name(s)

Bromfenac 0.09% eyedrops

Intervention Type

Drug

Intervention Name(s)

Nepafenac 0.1% eyedrops

Primary Outcome Measure Information:

Title

Prostaglandin E2 levels in the vitreous (pg/mL)

Time Frame

7 days after NSAID TID administration, following vitrectomy

Secondary Outcome Measure Information:

Title

NSAIDs concentration (ng/mL) into the vitreous

Description

Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system.

Time Frame

7 days after NSAID TID administration, following vitrectomy

Title

Adverse events

Time Frame

7 days after NSAID TID administration, following vitrectomy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with pucker scheduled for vitrectomy Exclusion Criteria: diabetes active inflammation

12. IPD Sharing Statement

Citations:

PubMed Identifier

33595256

Citation

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.

Results Reference

derived

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NSAIDs and PGE2 Levels in Vitrectomy Patients

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