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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05642325




Registration number
NCT05642325
Ethics application status
Date submitted
6/12/2022
Date registered
8/12/2022

Titles & IDs
Public title
Vamikibart in Participants With Uveitic Macular Edema
Scientific 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
Secondary ID [1] 0 0
GR44278
Universal Trial Number (UTN)
Trial acronym
Sandcat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveitic Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vamikibart
Other interventions - Sham

Experimental: Arm A - Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.

Experimental: Arm B - Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.

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.


Treatment: Drugs: Vamikibart
Participants will receive vamikibart IVT injection

Other interventions: Sham
Participants will receive a sham procedure that mimics an IVT injection.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with = 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Proportion of participants with = 15 letter improvement from baseline in BCVA at Week 20
Timepoint [1] 0 0
Week 20
Secondary outcome [2] 0 0
Change from baseline in BCVA at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Change from baseline in central subfield thickness (CST) at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change from Baseline in BCVA at Weeks 20 and 52
Timepoint [4] 0 0
Weeks 20 and 52
Secondary outcome [5] 0 0
Change from baseline in CST at Weeks 20 and 52
Timepoint [5] 0 0
Weeks 20 and 52
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Weeks 16 and 52
Secondary outcome [7] 0 0
Time to rescue treatment
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Number of rescue treatments received
Timepoint [8] 0 0
Up to Week 52
Secondary outcome [9] 0 0
Type of rescue treatments received
Timepoint [9] 0 0
Up to Week 52
Secondary outcome [10] 0 0
Proportion of participants with =15 letter improvement from baseline in BCVA at Week 16 and 52
Timepoint [10] 0 0
Weeks 16 and 52
Secondary outcome [11] 0 0
Proportion of participants without =15 letter loss from baseline in BCVA at Week 16 and 52
Timepoint [11] 0 0
Weeks 16 and 52
Secondary outcome [12] 0 0
Time to first PRN injection
Timepoint [12] 0 0
Up to Week 52
Secondary outcome [13] 0 0
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Timepoint [13] 0 0
Weeks 16 and 52
Secondary outcome [14] 0 0
Percentage of participants with ocular adverse events (AEs)
Timepoint [14] 0 0
Up to Week 52
Secondary outcome [15] 0 0
Percent change from baseline in corneal endothelial cell density at Week 24
Timepoint [15] 0 0
Week 24
Secondary outcome [16] 0 0
Percentage of participants with non-ocular AEs
Timepoint [16] 0 0
Up to Week 52
Secondary outcome [17] 0 0
Percentage of participants with adverse events of special interest (AESIs)
Timepoint [17] 0 0
Up to Week 52
Secondary outcome [18] 0 0
Percent change from baseline in corneal endothelial cell density at Week 52
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Aqueous humor (AH) concentration of vamikibart
Timepoint [19] 0 0
Up to Week 52
Secondary outcome [20] 0 0
Serum concentration of vamikibart
Timepoint [20] 0 0
Up to Week 52
Secondary outcome [21] 0 0
Anti-drug antibody titer to vamikibart
Timepoint [21] 0 0
Baseline to Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [3] 0 0
Eye Surgery Associates - Malvern
Recruitment hospital [4] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [5] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3178 - Rowville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
West Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Rosario
Country [18] 0 0
Argentina
State/province [18] 0 0
San Nicolás
Country [19] 0 0
Czechia
State/province [19] 0 0
Brno
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague
Country [21] 0 0
France
State/province [21] 0 0
Lyon cedex
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Nantes
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Bonn
Country [27] 0 0
Germany
State/province [27] 0 0
Dessau
Country [28] 0 0
Germany
State/province [28] 0 0
Freiburg
Country [29] 0 0
Germany
State/province [29] 0 0
Göttingen
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Heidelberg
Country [32] 0 0
Germany
State/province [32] 0 0
Köln
Country [33] 0 0
Germany
State/province [33] 0 0
Lübeck
Country [34] 0 0
Germany
State/province [34] 0 0
Munster
Country [35] 0 0
Germany
State/province [35] 0 0
Sulzbach
Country [36] 0 0
Germany
State/province [36] 0 0
Tübingen
Country [37] 0 0
India
State/province [37] 0 0
Karnataka
Country [38] 0 0
India
State/province [38] 0 0
Tamil NADU
Country [39] 0 0
India
State/province [39] 0 0
Telangana
Country [40] 0 0
India
State/province [40] 0 0
Uttar Pradesh
Country [41] 0 0
India
State/province [41] 0 0
Chandigarh
Country [42] 0 0
Japan
State/province [42] 0 0
Fukuoka
Country [43] 0 0
Japan
State/province [43] 0 0
Hiroshima
Country [44] 0 0
Japan
State/province [44] 0 0
Hokkaido
Country [45] 0 0
Japan
State/province [45] 0 0
Hyogo
Country [46] 0 0
Japan
State/province [46] 0 0
Kagoshima
Country [47] 0 0
Japan
State/province [47] 0 0
Kanagawa
Country [48] 0 0
Japan
State/province [48] 0 0
Osaka
Country [49] 0 0
Japan
State/province [49] 0 0
Saitama
Country [50] 0 0
Japan
State/province [50] 0 0
Tokyo
Country [51] 0 0
Japan
State/province [51] 0 0
Yamaguchi
Country [52] 0 0
Kazakhstan
State/province [52] 0 0
Almaty
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Busan
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Singapore
State/province [55] 0 0
Singapore
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Vizcaya
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Zaragoza
Country [60] 0 0
Switzerland
State/province [60] 0 0
Bern
Country [61] 0 0
Switzerland
State/province [61] 0 0
Binningen
Country [62] 0 0
Switzerland
State/province [62] 0 0
Lausanne
Country [63] 0 0
Switzerland
State/province [63] 0 0
Zürich
Country [64] 0 0
Turkey
State/province [64] 0 0
Ankara
Country [65] 0 0
Turkey
State/province [65] 0 0
Gaz?osmanpa?a
Country [66] 0 0
Turkey
State/province [66] 0 0
Istanbul
Country [67] 0 0
Turkey
State/province [67] 0 0
Konya
Country [68] 0 0
Turkey
State/province [68] 0 0
Lzmir
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Gloucester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-LaRoche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GR44278 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05642325