Eye drops to treat swelling related to eye inflammatio

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Key

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 <10 mg prednisone/day for >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 <=2 drops per day for >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 Âµm by Heidelberg spectral-domain OCT)

2. Baseline intraocular pressure >5 mmHg and <21 mmHg

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

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Central Subfield Thickness on OCTTimepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
1. Proportion of patients achieving resolution, improvement, and recurrence of Macular edema by the Week 4 visit and by the Week 24 visit <br/ ><br>2. BCVA at week 4 <br/ ><br>3. Quality of life assessment <br/ ><br>4. Occurrence of Ocular hypertension and CataractTimepoint: 4 - 24 weeks