InflammationPhase 1INCITENCT01164085
Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study
A Phase 1 study testing Intravitreal Ketorolac in people with Inflammation, run by Vanderbilt University at 1 site in United States.
Trial summary
Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inflammation
- What is being tested?
- Intravitreal Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2010
- Phase
- Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult volunteers
- Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
- Unable to tolerate corticosteroids due to side effects
Who cannot join
- 18 years or younger
- Have active ocular infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Eye Institute
Nashville, Tennessee, 37232-8808
About this study
Official title: Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study
Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.
Read the detailed description
A Phase I safety study of intravitreal ketorolac in patients with chronic inflammation and complications due to inflammation who have either failed medical therapy or who cannot tolerate corticosteroids due to side effects.
Specific Aims
- Test the safety of intraocular injection of 4mg of ketorolac in patients who have intractable uveitis or complications of uveitis such as chronic macular edema who are unable to tolerate corticosteroids due to their side effects.
- Test the efficacy of intraocular 4m ketorolac of treating inflammation or structural complications of inflammation in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.
- Conditions
- Inflammation
- Being tested
- Intravitreal Ketorolac
- Keywords
- Inflammation, Macular Edema
- Medical subject headings
- Inflammation, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal KetorolacDrug
Also called ketorolace, tromethamine, preservative free
4mg of intravitreal ketorolac
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | 4mg intravitreal injection of ketorolac Receives: Drug: Intravitreal Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Kim, MD, Vanderbilt University
- Investigators
- Stephen J Kim, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164085
- Sponsor's protocol ID
- 091196
- Acronym
- INCITE
- Status last verified
- Dec 2013
- First submitted
- 19 Apr 2010
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SJ, Doherty TJ, Cherney EF. Intravitreal ketorolac for chronic uveitis and macular edema: a pilot study. Arch Ophthalmol. 2012 Apr;130(4):456-60. doi: 10.1001/archopthalmol.2011.2627.
PubMed 22491916
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study
- ClinicalTrials.gov ID
- NCT01164085
- Acronym / sponsor ID
- INCITE / 091196
- Conditions
- Inflammation
- Keywords
- Inflammation, Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jul 2010 (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.
Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.
Detailed description
A Phase I safety study of intravitreal ketorolac in patients with chronic inflammation and complications due to inflammation who have either failed medical therapy or who cannot tolerate corticosteroids due to side effects.
Specific Aims
- Test the safety of intraocular injection of 4mg of ketorolac in patients who have intractable uveitis or complications of uveitis such as chronic macular edema who are unable to tolerate corticosteroids due to their side effects.
- Test the efficacy of intraocular 4m ketorolac of treating inflammation or structural complications of inflammation in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: Intravitreal Ketorolac4mg intravitreal injection of ketorolac |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult volunteers
- Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
- Unable to tolerate corticosteroids due to side effects
Key exclusion criteria (3 listed)
- 18 years or younger
- Have active ocular infection
- Pregnancy
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 |
|---|---|---|
| Intravitreal KetorolacAlso: ketorolace, tromethamine, preservative free4mg of intravitreal ketorolac | Drug | Ketorolac |
Primary outcome
Safety
Time frame: 90 days
Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
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 31 Dec 2013.
- Results publication: PubMed 22491916Kim SJ, Doherty TJ, Cherney EF. Intravitreal ketorolac for chronic uveitis and macular edema: a pilot study. Arch Ophthalmol. 2012 Apr;130(4):456-60. doi: 10.1001/archopthalmol.2011.2627.
- Related InfoLink provided by the sponsor.
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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.
Stephen J Kim, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravitreal Ketorolac in people with Inflammation, run by Vanderbilt University at 1 site in United States.
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 3 inclusion and 3 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety (time frame: 90 days). 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 NCT01164085, 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 31 Dec 2013.