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A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

NCT05642312

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Uveitic Macular Edema

Interventions: Vamikibart, Sham

Countries: United States, Austria, Brazil, Canada, China, Israel, Italy, Mexico

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 (77)
  • Los Angeles, California, United States
  • Lakewood, Colorado, United States
  • St. Petersburg, Florida, United States
  • Hagerstown, Maryland, United States
  • Minneapolis, Minnesota, United States
  • Omaha, Nebraska, United States
  • Bloomfield, New Jersey, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Erie, Pennsylvania, United States
  • West Columbia, South Carolina, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Graz, Austria
  • Linz, Austria
  • Vienna, Austria
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Rio de Janeiro, Brazil
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Québec, Canada
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Chongqing, China
  • + 47 more on CT.gov