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Trial record 1 of 1 for:    gr44277
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A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (Meerkat)

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ClinicalTrials.gov Identifier: NCT05642312
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease Intervention/treatment Phase
Uveitic Macular Edema Drug: Vamikibart Other: Sham Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 9, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05642312


Contacts
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Contact: Reference Study ID Number: GR44277 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05642312    
Other Study ID Numbers: GR44277
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases