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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Participants will receive 4 low-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
  • Drug: Vamikibart
    Participants will receive vamikibart IVT injection
    Other names:
    • RO7200220
Experimental
Arm B 		Participants will receive 4 high-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
  • Drug: Vamikibart
    Participants will receive vamikibart IVT injection
    Other names:
    • RO7200220
Sham Comparator
Arm C 		Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
  • Other: Sham
    Participants will receive a sham procedure that mimics an IVT injection.

Recruiting Locations

Barnet Dulaney Perkins Eye Center
Mesa, Arizona 85206

University of Arkansas For Medical Sciences
Little Rock, Arkansas 72205

Northern California Retina Vitreous Associates
Mountain View, California 94040

California Eye Specialists Medical group Inc.
Pasadena, California 91107

Retina Consultants of Southern California
Redlands, California 92373

Kaiser Permanente Riverside Medical Center
Riverside, California 92505

University of California, Davis, Eye Center
Sacramento, California 95817

Retinal Consultants Med Group
Sacramento, California 95825

Advanced Research
Deerfield Beach, Florida 33064

Retina Group of Florida
Fort Lauderdale, Florida 33308

University Retina and Macula Associates, PC
Oak Forest, Illinois 60452

University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan 48105

Assoc Retinal Consultants PC
Royal Oak, Michigan 48073

Mid Atlantic Retina
Cherry Hill, New Jersey 08034

Duke Eye Center
Durham, North Carolina 27705

Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio 44195-0001

Retina Research Institute of Texas
Abilene, Texas 79606

Retina Consultants of Texas; Katy Retina Center
Katy, Texas 77494

Retina Consultants of Texas
The Woodlands, Texas 77384-4167

West Virginia University
Morgantown, West Virginia 26506

University of Wisconsin; Ophthalmology and Visual Sciences
Madison, Wisconsin 53705

More Details

NCT ID
NCT05642325
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GR44278 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.