A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema

CompletadoFase 3ClinicalTrials.gov

ID: NCT05642325Tipo: INTERVENTIONALInicio: 23 de mar de 2023Fin estimado: 15 de dic de 2025

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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)
Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

Criterios de exclusión

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

Intervenciones

drug

Vamikibart

Participants will receive vamikibart IVT injection

other

Sham

Participants will receive a sham procedure that mimics an IVT injection.

Ubicaciones

Centro Privado de Ojos

Ciudad Autonoma Buenos Aires, Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina

Consultorios Medicos Oftalmológicos

Ciudad Autonoma Buenos Aires, Argentina

Oftalmologia Global

Rosario, Argentina

Organizacion Medica de Investigacion

San Nicolás, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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