- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164085
Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study (INCITE)
December 30, 2013 updated by: Stephen J. Kim, MD, Vanderbilt University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-8808
- Vanderbilt Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult volunteers
- Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
- Unable to tolerate corticosteroids due to side effects
Exclusion Criteria:
- 18 years or younger
- Have active ocular infection
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketorolac
4mg intravitreal injection of ketorolac
|
4mg of intravitreal ketorolac
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 90 days
|
Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen J Kim, MD, Vanderbilt University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
July 15, 2010
First Posted (Estimate)
July 16, 2010
Study Record Updates
Last Update Posted (Estimate)
December 31, 2013
Last Update Submitted That Met QC Criteria
December 30, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Uveal Diseases
- Inflammation
- Uveitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
Other Study ID Numbers
- 091196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Assistance Publique - Hôpitaux de ParisCompletedDigestive InflammationFrance
-
Pamukkale UniversityCompletedPeriodontal InflammationTurkey
-
Universidade Federal do ParaCompleted
-
KLE Society's Institute of Dental SciencesCompletedRegenerative InflammationIndia
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Singapore National Eye CentreCompletedIntraocular Inflammation in ChildrenSingapore
Clinical Trials on Intravitreal Ketorolac
-
Hemera BiosciencesWithdrawnGeographic Atrophy | Dry Age-related Macular Degeneration | Gene Therapy | Intravitreal Injection
-
Jeffrey S HeierKato Pharmaceuticals, Inc.CompletedVitreomacular Traction | Vitreomacular Adhesion | Vitreomacular AttachmentUnited States
-
Perfuse Therapeutics, Inc.Recruiting
-
Perfuse Therapeutics, Inc.Recruiting
-
Afyonkarahisar Health Sciences UniversityCompleted
-
Indonesia UniversityBayerCompletedDiabetic Retinopathy | Diabetic Macular Edema | Clinically Significant Macular EdemaIndonesia
-
Peregrine Eye and Laser InstituteCompletedDiabetic Macular Edema | Choroidal Neovascularization | Neovascular Age-related Macular Degeneration | Uveitic Macular Edema | Retinal Vein Occlusion With Macular EdemaPhilippines
-
Oman Medical Speciality BoardCompletedAcute Renal ColicOman
-
Eye & ENT Hospital of Fudan UniversityUnknownDiabetic Retinopathy | Diabetic Macular Edema | Cataract Diabetic
-
L.V. Prasad Eye InstitutePfizerWithdrawnMyopic Choroidal Neovascular MembraneIndia