With their ADX-102 Ophthalmic Solution (0.5%), Aldeyra Therapeutics, Inc. is seeking to better treat non-infectious anterior uveitis. Patients in this phase 3 trial will be randomized 1:1 and receive either the ADX-102 product or simply the vehicle for this solution. Aldeyra will gather information on the safety and efficacy of their treatment in regards to the anterior chamber cell count and the symptoms of anterior uveitis over the course of this approximately five week trial. Subjects between the ages of 18 and 85 will have seven visits throughout the course of the study and will undergo a variety of testing. ADX-102 (0.5%) has previously been shown to be safe in other non-infectious anterior uveitis patients who were treated topically four times per day.
The purpose of this study is to investigate the safety and effectiveness of two different dose strengths (10 µg or 15 µg) of the Bimatoprost Sustained Release (SR) implant, compared to treatment with Timolol 0.5% eye drops in lowering eye pressure in subjects with open angle glaucoma or high eye-pressure (ocular hypertension). Bimatoprost SR is a small biodegradable implant that is injected and sits in the anterior chamber of the eye releasing drug for 3-4 months. The study is controlled with randomized experimental, and positive control treatment groups. The study requires follow up appointments over a 22 month period.
This change from baseline clinical trial seeks to determine the changes in corneal endothelial cell density in eyes treated with a Retisert Implant (fluocinolone acetonide, 0.59 mg). Patients 12 years of age and older who are scheduled for an intravitreal Retisert implantation are eligible for this year long study.
This is a prospective, multi-center, randomized, double-masked Phase 3 non-inferiority clinical trial designed to evaluate whether the study treatment (EGP-437) is non-inferior to the control treatment [prednisolone acetate ophthalmic suspension (1%)] to within a 10% margin in patients with non-infectious anterior segment uveitis. Patients will be randomly assigned in at 1:1 ratio to the treatment groups. Approximately 250 patients are sought for participation in this study at multiple sites.
This is a phase IV clinical trial of a repository corticotrophin injection (H.P. Acthar Gel) in order to treat non-infectious retinal vasculitis. Throughout the duration of this open label study, the safety and efficacy of the treatment will be evaluated. Participation is limited to patients 18 years of age or older with retinal vasculitis associated with a non-infectious ocular inflammatory disease. Patients will be followed for 24 weeks over the course of 6 office visits.
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Uveitis and Steroid-Sparing Therapy
Presented by C. Stephen Foster, MD, FACS, FACR
Audio-Digest Ophthalmology Volume 56, Issue 15