A Study to Investigate RO7200220 in Participants With Uveitic Macular Edema

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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, 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; prior or concomitant use of IVT Methotrexate

• Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1

• Any 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 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