Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious … (NCT02595398) | Clinical Trial Compass
CompletedPhase 3
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
United States160 participantsStarted 2015-11-17
Plain-language summary
The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
* Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
* Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye
Exclusion Criteria:
* Any active ocular disease or infection in the study eye other than uveitis
* Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
What they're measuring
1
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks