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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DME Participants:
Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
Macular edema associated with DR defined as macular thickening by spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: central subfield thickness (CST) of ≥325 μm with Spectralis.
Decreased visual acuity (VA) attributable primarily to DME, with BCVA letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts (20/40 -20/400 Snellen equivalent).
Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
UME Participants:
Diagnosis of noninfectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis). Active and inactive NIU is allowed.
Macular edema associated with NIU defined as macular thickening by SD-OCT involving the center of the macula: CST of ≥325 μm with Spectralis.
Decreased VA attributable primarily to UME, with BCVA letter score of 78 to 19 letters (both inclusive) on ETDRS-like charts (20/32 - 20/400 Snellen equivalent).
Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
Either treatment naive or previously treated in the study eye or systematically (with washout periods and maximum doses applicable for specific treatments).
You may not be if
Any major illness or major surgical procedure within 1 month prior to Day 1
Any febrile illness within 1 week prior to screening or Day 1
Any stroke or myocardial infarction within 12 months prior to Day 1
Any active proliferative DR (DME participants only)
Panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
History of vitreoretinal surgery/pars plana vitrectomy
Any cataract surgery within 3 months prior to Day 1 or any planned surgery during the study
History of any glaucoma surgery including laser glaucoma procedures
Uncontrolled glaucoma
History of rubeosis iridis
Any active ocular or periocular infection on Day 1
Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation (DME participants only)
Any prior or concomitant periocular or IVT corticosteroids in the study eye (DME treatment naive participants only)
Use of any systemic corticosteroids within 1 month prior to Day 1 (stable oral prednisone for UME participants allowed)
Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1
Any concurrent use of biologics for immune-related diseases
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