RO7200220 in Participants With Uveitic Macular Edema (Sandcat)
Uveitic Macular Edema
About this trial
This is an interventional treatment trial for Uveitic Macular Edema
Eligibility Criteria
Inclusion Criteria: Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol Diagnosis of macular edema associated with non-infectious uveitis (NIU) Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts Exclusion Criteria: Evidence of active or latent syphilis infection Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis Serious acute or chronic medical or psychiatric illness History of major ocular and non-ocular surgical procedures Uncontrolled IOP or glaucoma or chronic hypotony Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1 Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1 Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1 Diagnosis of macular edema due to any cause other than NIU Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Sites / Locations
- Barnet Dulaney Perkins Eye CenterRecruiting
- Northern California Retina Vitreous AssociatesRecruiting
- California Eye Specialists Medical group Inc.Recruiting
- Retina Consultants of Southern CaliforniaRecruiting
- Kaiser Permanente Riverside Medical CenterRecruiting
- University of California, Davis, Eye CenterRecruiting
- Retinal Consultants Med GroupRecruiting
- Advanced ResearchRecruiting
- Retina Group of FloridaRecruiting
- University Retina and Macula Associates, PCRecruiting
- University of Michigan, Kellogg Eye CenterRecruiting
- Assoc Retinal Consultants PCRecruiting
- Mid Atlantic RetinaRecruiting
- Duke Eye CenterRecruiting
- Cleveland Clinic Foundation; Cole Eye InstituteRecruiting
- Retina Research Institute of TexasRecruiting
- Retina Consultants of Texas; Katy Retina CenterRecruiting
- Retina Consultants of TexasRecruiting
- University of Wisconsin; Ophthalmology and Visual SciencesRecruiting
- Centro Privado de OjosRecruiting
- Buenos Aires MáculaRecruiting
- Consultorios Medicos Oftalmológicos
- Oftalmologia Global
- Organizacion Medica de InvestigacionRecruiting
- Sydney Eye HospitalRecruiting
- Centre For Eye Research AustraliaRecruiting
- Eye Surgery AssociatesRecruiting
- Retina Specialists VictoriaRecruiting
- The Lions Eye InstituteRecruiting
- General Teaching Hospital Prague; Ophthalmology clinicRecruiting
- CHU Nantes - Hôtel Dieu; OphthalmologyRecruiting
- Hopital Lariboisiere; OphtalmologieRecruiting
- Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; OphthalmologyRecruiting
- Universitätsklinikum Freiburg, Klinik für AugenheilkundeRecruiting
- Universitätsmedizin Göttingen Georg-August-Universität; Klinik für AugenheilkundeRecruiting
- Universitätsklinik Heidelberg; AugenklinikRecruiting
- Universitätsklinikum Köln; AugenklinikRecruiting
- St. Franziskus HospitalRecruiting
- Universitäts-Augenklinik TübingenRecruiting
- Kyushu University HospitalRecruiting
- Hiroshima University HospitalRecruiting
- Hokkaido University HospitalRecruiting
- Kobe University Hospital; Endocrine Internal MedicineRecruiting
- Kagoshima University HospitalRecruiting
- Yokohama City University Hospital
- Japan Community Health care Organization Osaka HospitalRecruiting
- National Defense Medical College HospitalRecruiting
- Tokyo Medical and Dental University HospitalRecruiting
- Kyorin University HospitalRecruiting
- Nippon Medical School Tama Nagayama HospitalRecruiting
- Yamaguchi University Hospital
- National University Hospital; Ophthalmology DepartmentRecruiting
- Hospital Universitari de Bellvitge; Servicio de OftalmologiaRecruiting
- Fundacion Jimenez Diaz-UTE; Servicio OftalmologiaRecruiting
- Hospital Universitario Miguel Servet; Servicio de OftalmologiaRecruiting
- Inselspital Bern Ophthalmologische KlinikRecruiting
- Vista Klinik Ophthalmologische KlinikRecruiting
- Stadtspital Triemli Ophthalmologische KlinikRecruiting
- Hacettepe University Medical Faculty; Department of OphthalmologyRecruiting
- Istanbul University Cerrahpasa Faculty of Medicine
- Ege Üniversitesi Tip Fakültesi
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
Arm A
Arm B
Arm C
Participants will receive 4 low-dose RO7200220 intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
Participants will receive 4 high-dose RO7200220 IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.