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Vamikibart in Participants With Uveitic Macular Edema
Vamikibart in Participants With Uveitic Macular Edema

NCT05642325

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Uveitic Macular Edema

Interventions: Vamikibart, Sham

Countries: United States, Argentina, Australia, China, Czechia, France, Germany, India

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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
Locations (94)
  • Phoenix, Arizona, United States
  • Sun City, Arizona, United States
  • Fullerton, California, United States
  • Mountain View, California, United States
  • Pasadena, California, United States
  • Redlands, California, United States
  • Riverside, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Deerfield Beach, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Oak Forest, Illinois, United States
  • Hagerstown, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Erie, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Abilene, Texas, United States
  • Bellaire, Texas, United States
  • Katy, Texas, United States
  • Fairfax, Virginia, United States
  • Madison, Wisconsin, United States
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Rosario, Argentina
  • San Nicolás, Argentina
  • Sydney, New South Wales, Australia
  • East Melbourne, Victoria, Australia
  • + 64 more on CT.gov