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NCT05642325
RO7200220 in Participants With Uveitic Macular Edema
Conditions: Uveitic Macular Edema
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 225
Sponsor: Hoffmann-La Roche
Location: Turkey
Summary
This study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.
Eligibility Criteria
Inclusion Criteria:Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocolDiagnosis 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 chartsExclusion Criteria:Evidence of active or latent syphilis infectionEvidence of active or latent tuberculosis infection, or previous or current HIV diagnosisSerious acute or chronic medical or psychiatric illnessHistory of major ocular and non-ocular surgical proceduresUncontrolled IOP or glaucoma or chronic hypotonyAny anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study imagesPrior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; prior or concomitant use of IVT MethotrexatePrior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1Any topical ocular corticosteroid/NSAIDs 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 D1Diagnosis of macular edema due to any cause other than NIUAny major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Source: ClinicalTrials.gov (NCT05642325). StuddyBuddy aggregates publicly available trial information.