Vamikibart in Participants With Uveitic Macular Edema (Sandcat)

Roche

Status and phase: Enrolling; Phase 3

Conditions: Uveitic Macular Edema

Treatments: Other: Sham; Drug: Vamikibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT05642325

GR44278

Details and patient eligibility

About

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

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

Arm A

Experimental group

Description:

Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.

Treatment:

Drug: Vamikibart

Arm B

Experimental group

Description:

Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.

Treatment:

Drug: Vamikibart

Arm C

Sham Comparator group

Description:

Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.

Treatment:

Other: Sham