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A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
22-5108
Category
Eye/Ocular Disorders
Principal Investigator
Contact
Joseph Privratsky
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05642312
For detailed technical eligibility, visit ClinicalTrials.gov.