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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal triamcinolone | Active Comparator | subjects will receive intravitreal injection of 2mg /0.05 ml of preservative free triamcinolone acetonide ( otherwise known as triesence) |
|
| posterior subtenon triamcinolone | Active Comparator | subjects will receive posterior subtenon injection of 40mg /1 ml of preserved triamcinolone acetonide ( otherwise known as kenalog) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide | Drug | injection of triamcinolone acetonide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity( BCVA) | Best corrected visual acuity will be assessed using the Snellen chart | at 1,3 and 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in central macular thickness in micrometers | A spectral domain optical coherence tomography device will be used to capture central macular thickness | at 1,3 and 6 months after intervention |
| Percentage of eyes that develop side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10896343 | Background | 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. | |
| 17083528 | Background | Sivaprasad 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. |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| at 1,3 and 6 months after intervention |
| 21652023 | Background | Leder 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. |
| D012164 |
| Retinal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |