Skip to main content
OpenTrials
Completed

NCT Number: NCT05642312

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LKH-Univ.Klinikum Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vamikibart

Drug

Participants will receive vamikibart IVT injection

Other names: RO7200220

SHAM

Other

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

Primary outcomes

  1. Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16

    Time frame: Week 16

Secondary outcomes

  1. Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20

    Time frame: Week 20

  2. Change from baseline in BCVA at Week 16

    Time frame: Week 16

  3. Change from baseline in central subfield thickness (CST) at Week 16

    Time frame: Week 16

  4. Change from Baseline in BCVA at Weeks 20 and 52

    Time frame: Weeks 20 and 52

  5. Change from baseline in CST at Weeks 20 and 52

    Time frame: Weeks 20 and 52

  6. Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52

    Time frame: Weeks 16 and 52

  7. Time to rescue treatment

    Time frame: Up to Week 52

  8. Number of rescue treatments received

    Time frame: Up to Week 52

  9. Type of rescue treatments received

    Time frame: Up to Week 52

  10. Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52

    Time frame: Weeks 16 and 52

  11. Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52

    Time frame: Weeks 16 and 52

  12. Number of PRN injections received

    Time frame: Up to Week 52

  13. Time to first PRN injection

    Time frame: Up to Week 52

  14. Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52

    Time frame: Weeks 16 and 52

  15. Percentage of participants with ocular adverse events (AEs)

    Time frame: Up to Week 52

  16. Percentage of participants with non-ocular AEs

    Time frame: Up to Week 52

  17. Percent change from baseline in corneal endothelial cell density at Week 24

    Time frame: Week 24

  18. Percentage of participants with adverse events of special interest (AESIs)

    Time frame: Up to Week 52

  19. Percent change from baseline in corneal endothelial cell density at Week 52

    Time frame: Week 52

  20. Aqueous humor (AH) concentration of vamikibart

    Time frame: Up to Week 52

  21. Serum concentration of vamikibart

    Time frame: Up to Week 52

  22. Anti-drug antibody titer to vamikibart

    Time frame: Baseline to Week 52

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: Meerkat

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.