UveitisPhase 4NCT02598869
Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema
A Phase 4 study testing Triamcinolone Acetonide in people with Uveitis and Cystoid Macular Edema, run by Oregon Health and Science University.
Trial summary
Macular edema is the most common sight threatening complication of uveitis which can lead to permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for treatment of cystoid macular edema(CME) is well established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Cystoid Macular Edema
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2015to 15 May 2016
- Phase
- Phase 4
- 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
- Male or non-pregnant female at least 18 years of age at the time of consent
- One or both eyes having CME associated with non-infectious uveitis
- Subject has the ability to understand and sign the Informed Consent Form
- Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Allergy to triamcinolone acetonide
- History of any type of non-infectious uveitis without macular edema
- Vitreous hemorrhage
- Uveitis with infectious etiology
- CME due to non-uveitis causes
- Previous viral retinitis or uveitis
Show all 11Show fewer
- Toxoplasmosis scar in study eye or scar related to viral retinitis
- Media opacity interfering with optical coherence tomography (OCT) or evaluation of the retina and vitreous
- Patient may not have had prior treatment for CME within the past 3 months including anti-VEGF (vascular endothelial growth factor), periocular or intravitreal steroid
- Pregnant or nursing women; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
- Subjects unwilling to comply with the study protocol or who are likely to be lost to follow-up within 6 months
About this study
Official title: Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema (CME)
Macular edema is the most common sight threatening complication of uveitis which can lead to permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for treatment of cystoid macular edema(CME) is well established. The purpose of this study is to compare the safety and efficacy of injecting the study drug inside the eye(intravitreal injection) and behind the eye(subtenon injection)
Read the detailed description
The study is randomized interventional non inferiority study that will enroll 30 adults aged 18 or older with the diagnosis of cystoid macular edema secondary to non-infectious uveitis. Potential subjects will be recruited from the retina and uveitis clinics at the Casey Eye Institute, Oregon health and science University(OHSU). Potential recruits will be asked to sign and date the informed consent and a copy will be given to subject prior to any study procedure. Subjects will have a screening visit before the injection procedure so that the study doctor can decide if they meet the criteria to be in the study. This study requires 6 visits to the clinic and will take 6 months to complete. During the screening visit, medical/ surgical/ ocular history and will be collected from the subject and medical records. Laboratory tests will be performed to rule out infectious uveitis if the subject has not already had infectious types of uveitis ruled out since the time of diagnosis of uveitis. Urine collection for pregnancy test for females of childbearing potential will be done. Examination of subjects will include measurement of visual acuity, examination of the front and back part of the eye, measurement of the eye pressure . A scan of the retina will be obtained by spectral domain optical coherence tomography (SD-OCT). During the injection visit, history, examination, and pregnancy tests will be repeated in addition to receiving the injection. Subjects will be randomized to either injecting the study drug by intravitreal or subtenon routes. Examination after injection will be performed to rule out immediate complications. Then subjects will have 4 follow-up visits (2 weeks, 1 month, 3 months and 6 months). During each visit, subjects will be asked about adverse events, concomitant medications, how their eyes feel in addition to obtaining a clinical examination and OCT.
- Conditions
- Uveitis, Cystoid Macular Edema
- Being tested
- Triamcinolone Acetonide
- Keywords
- Triamcinolone acetonide
- Medical subject headings
- Uveitis, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called triesence, kenalog
injection of triamcinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal triamcinolone | Active comparator | subjects will receive intravitreal injection of 2mg /0.05 ml of preservative free triamcinolone acetonide ( otherwise known as triesence) Receives: Drug: Triamcinolone Acetonide |
| posterior subtenon triamcinolone | Active comparator | subjects will receive posterior subtenon injection of 40mg /1 ml of preserved triamcinolone acetonide ( otherwise known as kenalog) Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in best corrected visual acuity( BCVA)
Best corrected visual acuity will be assessed using the Snellen chart
Measured: at 1,3 and 6 months after intervention
Secondary outcomes (2)
Change in central macular thickness in micrometers
A spectral domain optical coherence tomography device will be used to capture central macular thickness
Measured: at 1,3 and 6 months after intervention
Percentage of eyes that develop side effects
Measured: at 1,3 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start30 Nov 2015
- Primary completion15 May 2016
- Study completion15 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phoebe Lin, MD,PhD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598869
- Sponsor's protocol ID
- 00011584
- Status last verified
- Feb 2019
- First submitted
- 31 Aug 2015
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guex-Crosier Y. The pathogenesis and clinical presentation of macular edema in inflammatory diseases. Doc Ophthalmol. 1999;97(3-4):297-309. doi: 10.1023/a:1002130005227.
PubMed 10896343Sivaprasad S, McCluskey P, Lightman S. Intravitreal steroids in the management of macular oedema. Acta Ophthalmol Scand. 2006 Dec;84(6):722-33. doi: 10.1111/j.1600-0420.2006.00698.x.
PubMed 17083528Leder HA, Jabs DA, Galor A, Dunn JP, Thorne JE. Periocular triamcinolone acetonide injections for cystoid macular edema complicating noninfectious uveitis. Am J Ophthalmol. 2011 Sep;152(3):441-448.e2. doi: 10.1016/j.ajo.2011.02.009. Epub 2011 Jun 8.
PubMed 21652023
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema (CME)
- ClinicalTrials.gov ID
- NCT02598869
- Acronym / sponsor ID
- 00011584
- Conditions
- Uveitis, Cystoid Macular Edema
- Keywords
- Triamcinolone acetonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 15 May 2016 (actual)
- First posted
- 6 Nov 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.
Macular edema is the most common sight threatening complication of uveitis which can lead to permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for treatment of cystoid macular edema(CME) is well established. The purpose of this study is to compare the safety and efficacy of injecting the study drug inside the eye(intravitreal injection) and behind the eye(subtenon injection)
Detailed description
The study is randomized interventional non inferiority study that will enroll 30 adults aged 18 or older with the diagnosis of cystoid macular edema secondary to non-infectious uveitis. Potential subjects will be recruited from the retina and uveitis clinics at the Casey Eye Institute, Oregon health and science University(OHSU). Potential recruits will be asked to sign and date the informed consent and a copy will be given to subject prior to any study procedure. Subjects will have a screening visit before the injection procedure so that the study doctor can decide if they meet the criteria to be in the study. This study requires 6 visits to the clinic and will take 6 months to complete. During the screening visit, medical/ surgical/ ocular history and will be collected from the subject and medical records. Laboratory tests will be performed to rule out infectious uveitis if the subject has not already had infectious types of uveitis ruled out since the time of diagnosis of uveitis. Urine collection for pregnancy test for females of childbearing potential will be done. Examination of subjects will include measurement of visual acuity, examination of the front and back part of the eye, measurement of the eye pressure . A scan of the retina will be obtained by spectral domain optical coherence tomography (SD-OCT). During the injection visit, history, examination, and pregnancy tests will be repeated in addition to receiving the injection. Subjects will be randomized to either injecting the study drug by intravitreal or subtenon routes. Examination after injection will be performed to rule out immediate complications. Then subjects will have 4 follow-up visits (2 weeks, 1 month, 3 months and 6 months). During each visit, subjects will be asked about adverse events, concomitant medications, how their eyes feel in addition to obtaining a clinical examination and OCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal triamcinolone | Active comparator | Drug: Triamcinolone Acetonidesubjects will receive intravitreal injection of 2mg /0.05 ml of preservative free triamcinolone acetonide ( otherwise known as triesence) |
| posterior subtenon triamcinolone | Active comparator | Drug: Triamcinolone Acetonidesubjects will receive posterior subtenon injection of 40mg /1 ml of preserved triamcinolone acetonide ( otherwise known as kenalog) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant female at least 18 years of age at the time of consent
- One or both eyes having CME associated with non-infectious uveitis
- Subject has the ability to understand and sign the Informed Consent Form
- Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria (11 listed)
- Allergy to triamcinolone acetonide
- History of any type of non-infectious uveitis without macular edema
- Vitreous hemorrhage
- Uveitis with infectious etiology
- CME due to non-uveitis causes
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: triesence, kenaloginjection of triamcinolone acetonide | Drug | Intravitreal triamcinolone, posterior subtenon triamcinolone |
Primary outcome
Mean change in best corrected visual acuity( BCVA)
Time frame: at 1,3 and 6 months after intervention
Best corrected visual acuity will be assessed using the Snellen chart
2 secondary outcomes
Change in central macular thickness in micrometers
Time frame: at 1,3 and 6 months after intervention
Percentage of eyes that develop side effects
Time frame: at 1,3 and 6 months after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Background: PubMed 10896343Guex-Crosier Y. The pathogenesis and clinical presentation of macular edema in inflammatory diseases. Doc Ophthalmol. 1999;97(3-4):297-309. doi: 10.1023/a:1002130005227.
- Background: PubMed 17083528Sivaprasad S, McCluskey P, Lightman S. Intravitreal steroids in the management of macular oedema. Acta Ophthalmol Scand. 2006 Dec;84(6):722-33. doi: 10.1111/j.1600-0420.2006.00698.x.
- Background: PubMed 21652023Leder HA, Jabs DA, Galor A, Dunn JP, Thorne JE. Periocular triamcinolone acetonide injections for cystoid macular edema complicating noninfectious uveitis. Am J Ophthalmol. 2011 Sep;152(3):441-448.e2. doi: 10.1016/j.ajo.2011.02.009. Epub 2011 Jun 8.
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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 4 study testing Triamcinolone Acetonide in people with Uveitis and Cystoid Macular Edema, run by Oregon Health and Science University.
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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 7 Feb 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mean change in best corrected visual acuity( BCVA) (time frame: at 1,3 and 6 months after intervention). 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 NCT02598869, which also lists 3 linked publications.
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 7 Feb 2019.