Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Diluprednate 0.05%: Diluprednate 0.05% topical corticosteroid eye drop 4x/day until Week 4 visit. If edema resolves, decrease to 1x/day until Week 6 visit, then stop. If not resolved at
Sponsors
Proctor Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Key Inclusion criteria: 1. >=18 years of age 2. Diagnosis of anterior, intermediate, posterior, or panuveitis (can be infectious or non-infectious) 3. Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature 4. If on oral corticosteroids, a stable dose of 4 weeks 5. If on systemic corticosteroid-sparing immunomodulatory therapy, a stable dose for >4 weeks 6. If using prednisolone acetate 1% drops, stable regimen of 4 weeks 7. If infectious uveitis, inflammation must be inactive or minimally active per definition above and on stable dose of treatment for >=4 weeks with no anticipated changes to treatment during the trial Eye-level Inclusion Criteria: 1. ME defined as thickening of the 1mm central subfield of the macula greater than 2 standard deviations above normal thickness ( >320 µm by Heidelberg spectral-domain OCT) 2. Baseline intraocular pressure >5 mmHg and 3. Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography 4. Best-corrected visual acuity of 5/200 or better
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline 2. Known allergy or hypersensitivity to any component of the study drugs 3. History of central serous chorioretinopathy in either eye 4. Intravitreal or periocular corticosteroid injection in the past 8 weeks, dexamethasone implant in the past 12 months, or a fluocinolone acetonide implant in the past 3 years 5. Presence of an epiretinal membraneâ??noted clinically or by OCTâ??in the study eye, thought to be significant enough to preclude improvement of ME 6. Previous pars plana vitrectomy 7. History of severe glaucoma (C/D ratio > 0.9 or any notching of optic nerve to rim) 8. Prior use of difluprednate or nepafenac in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Central Subfield Thickness on OCTTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients achieving resolution, improvement, and recurrence of Macular edema by the Week 4 visit and by the Week 24 visit 2. BCVA at week 4 3. Quality of life assessment 4. Occurrence of Ocular hypertension and CataractTimepoint: 4 - 24 weeks | — |
Countries
India
Contacts
Public ContactDr S R Rathinam
Aravind Eye Hospital and PG Institute of Ophthalmology
Outcome results
None listed