Last updated 13 days ago
Vamikibart in Participants With Uveitic Macular Edema
225 patients around the world
Available in United States, Argentina
Hoffmann-La Roche
3Research sites
225Patients around the world
This study is for people with
Macular edema
Uveitic macular edema
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 charts
- Evidence of active or latent syphilis infectionEvidence of active or latent tuberculosis infection and/or positive tuberculosis assay, 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; received IVT Methotrexate within 4 months prior to Day 1Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1Topical 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 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
Sites
Organización Médica de Investigación (OMI)
Recruiting
Buenos Aires Mácula S.A.
Recruiting
Centro Médico Oftalmología Global
Recruiting
StudySandcat
SponsorHoffmann-La Roche
Conditions
Uveitic macular edema
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05642325
