Macular Edema Nepafenac vs. Difluprednate (MEND) Uveitis Trial

Proctor Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

Proctor Foundation