Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema

Korábbi kezelés

• A decrease in BCVA due to causes other than UME or PSME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that are likely to decrease BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
• Unstable (increasing) dose of immunosuppressives during 2 months prior to the baseline visit. Immunosuppressives are defined as antimetabolites (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine and tacrolimus, among others) and biologics (including adalimumab, infliximab, tocilizumab, golimumab, secukinumab and rituximab, and others).
• Treated with more than 2 types of immunosuppressives (excluding steroids) within 2 months prior to baseline visit.
• Unstable (increasing) dose of oral prednisone for 1 month before baseline visit.
• Oral prednisone therapy at dose > 10 mg daily (or equivalent) within 1 month prior to baseline visit.
• History of contact lens use within 2 weeks prior to baseline or at any time during the study.

Más betegség

• History of glaucoma and documented glaucomatous optic neuropathy or clinically significant ocular hypertension in the opinion of the investigator, involving an IOP ≥ 25 mmHg on > 3 anti-glaucoma medications in the study eye.
• Any other ocular disease that could cause substantial reduction in BCVA, including retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis involving the macula in the study eye, other retinal inflammatory or infectious diseases.
• Active peri-ocular or ocular infection (e.g., blepharitis, keratitis, scleritis, or conjunctivitis).
• History of infectious uveitis.
• History of increased intraocular pressure with topical steroid therapy.

Életkor

• Macular edema considered to be due to a cause other than UME or PSME. An eye is not considered eligible if: (1) the macular edema is considered to be related to diabetes (2) clinical exam and/or OCT suggests that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, retinal vein occlusion, or drug toxicity.

Egyéb

• Subjects who meet any of the following exclusion criteria will not be included in the study
• Use of other ophthalmic formulations during the study. However, intraocular pressure (IOP) lowering eye drops are allowed if they become necessary due to increased IOP.
• High myopia (-8 diopter or more correction) in the study eye.
• Any form of diabetic retinopathy.
• Pregnancy/Breastfeeding
  • For UME:
• Active uveitis as determined by the presence of anterior chamber cells or vitreous cells.

• Age 18 years or older.
• Diagnosis of Uveitic macular edema (UME) or post-surgical macular edema (PSME).
• Can provide written informed consent prior to any study procedure being performed, able and willing to follow all instructions, and attend all study visits.
• UME of less than 1 years in duration or PSME of less than 1 year, with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥ 320 µm by SD-OCT at baseline (as measured by the central reading center employing Heidelberg Spectralis spectral domain optical coherence tomography, SD-OCT). Note: Recurrent CME is also eligible if the current episode is of less than 1 year.
• An ETDRS BCVA letter score ≤ 70 (Snellen 20/40) and ≥ 35 (Snellen 20/200) in the study eye at baseline (Visit 2).
• A documented diagnosis of inactive/stable uveitis (for UME) at the screening visit.
• A trial of topical NSAID or topical corticosteroids (for PSME) for at least one consecutive month but less than 3 consecutive months before screening visit with documented treatment failure on SD-OCT or based on investigator's clinical evaluation.
  • Note: If both eyes are eligible, the eye with the worse BCVA will be selected as the study eye. If both eyes have the same BCVA, the non-dominant eye will be selected.