a study to investigate ro7200220 as monotherapy and in combination with ranibizumab in participants with diabetic and uveitic macular edema

Conditions: Diabetic Macular Edema; Uveitic Macular Edema

Summary: the purpose of this study was to assess the safety and tolerability of ro7200220 as monotherapy (diabetic macular edema \[dme\] or uveitic macular edema \[ume\] population) and in combination with ranibizumab (dme population only).


Eligibility criteria:
inclusion criteria: 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). exclusion criteria: * 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