Vitreous InflammationPhase 3NCT02361645
NSAIDs and PGE2 Levels in Vitrectomy Patients
A Phase 3 study testing Ketorolac 0.5% eyedrops, Indomethacin 0.5% eyedrops and Bromfenac 0.09% eyedrops in people with Vitreous Inflammation, run by Università degli Studi di Brescia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreous Inflammation
- What is being tested?
- Ketorolac 0.5% eyedrops, Indomethacin 0.5% eyedrops and Bromfenac 0.09% eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with pucker scheduled for vitrectomy
Who cannot join
- diabetes
- active inflammation
About this study
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%
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
- Being tested
- Ketorolac 0.5% eyedrops, Indomethacin 0.5% eyedrops, Bromfenac 0.09% eyedrops, Nepafenac 0.1% eyedrops
- Keywords
- nonsteroidal antiinflammatory drugs, prostaglandin E2, vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac 0.5% eyedropsDrug
Indomethacin 0.5% eyedropsDrug
Bromfenac 0.09% eyedropsDrug
Nepafenac 0.1% eyedropsDrug
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No NSAIDs were administered prior to surgery |
| Ketorolac eyedrops | Experimental | Ketorolac 0.5% eyedrops were administered prior to surgery Receives: Drug: Ketorolac 0.5% eyedrops |
| Indomethacin eyedrops | Experimental | Indomethacin 0.5% eyedrops were administered prior to surgery Receives: Drug: Indomethacin 0.5% eyedrops |
| Nepafenac eyedrops | Experimental | Nepafenac 0.1% eyedrops were administered prior to surgery Receives: Drug: Nepafenac 0.1% eyedrops |
| Bromfenac eyedrops | Experimental | Bromfenac 0.09% eyedrops were administered prior to surgery Receives: Drug: Bromfenac 0.09% eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostaglandin E2 levels in the vitreous (pg/mL)
Measured: 7 days after NSAID TID administration, following vitrectomy
Secondary outcomes (2)
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.
Measured: 7 days after NSAID TID administration, following vitrectomy
Adverse events
Measured: 7 days after NSAID TID administration, following vitrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitreous InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Russo, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361645
- Sponsor's protocol ID
- Vitreo001
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33595256
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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%
- ClinicalTrials.gov ID
- NCT02361645
- Acronym / sponsor ID
- Vitreo001
- Conditions
- Vitreous Inflammation
- Keywords
- nonsteroidal antiinflammatory drugs, prostaglandin E2, vitrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No NSAIDs were administered prior to surgery |
| Ketorolac eyedrops | Experimental | Drug: Ketorolac 0.5% eyedropsKetorolac 0.5% eyedrops were administered prior to surgery |
| Indomethacin eyedrops | Experimental | Drug: Indomethacin 0.5% eyedropsIndomethacin 0.5% eyedrops were administered prior to surgery |
| Nepafenac eyedrops | Experimental | Drug: Nepafenac 0.1% eyedropsNepafenac 0.1% eyedrops were administered prior to surgery |
| Bromfenac eyedrops | Experimental | Drug: Bromfenac 0.09% eyedropsBromfenac 0.09% eyedrops were administered prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with pucker scheduled for vitrectomy
Key exclusion criteria (2 listed)
- diabetes
- active inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Prostaglandin E2 levels in the vitreous (pg/mL)
Time frame: 7 days after NSAID TID administration, following vitrectomy
2 secondary outcomes
NSAIDs concentration (ng/mL) into the vitreous
Time frame: 7 days after NSAID TID administration, following vitrectomy
Adverse events
Time frame: 7 days after NSAID TID administration, following vitrectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Derived from this study: PubMed 33595256Morescalchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac 0.5% eyedrops, Indomethacin 0.5% eyedrops and Bromfenac 0.09% eyedrops in people with Vitreous Inflammation, run by Università degli Studi di Brescia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostaglandin E2 levels in the vitreous (pg/mL) (time frame: 7 days after NSAID TID administration, following vitrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.