Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Vamikibart in Participants With Uveitic Macular Edema
