Uveitic Macular EdemaPhase 3MeerkatNCT05642312
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
A Phase 3 study testing Vamikibart in people with Uveitic Macular Edema, run by Hoffmann-La Roche at 77 sites in 14 countries.
Trial summary
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitic Macular Edema
- What is being tested?
- Vamikibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 77 sitesin 14 countries
- Study dates
- 9 Jan 2023to 9 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
77 sites in 14 countries.
77 sites in 14 countries
United States16 sites
Austin Clinical Research LLC
Austin, Texas, 78750
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43212
Texas Retina Associates
Dallas, Texas, 75231
Erie Retina Research
Erie, Pennsylvania, 16507-1429
Cumberland Valley Retina PC
Hagerstown, Maryland, 21740
Colorado Retina Associates, PC
Lakewood, Colorado, 80228
Kaiser Permanente Southern California
Los Angeles, California, 90027
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, 55435
Tennessee Retina PC
Nashville, Tennessee, 37203
Truhlsen Eye Institute
Omaha, Nebraska, 68106-5540
Oregon Health & Science Uni
Portland, Oregon, 97239
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711-1141
Palmetto Retina Center
West Columbia, South Carolina, 29169
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, 27157
China10 sites
Peking Union Medical College Hospital
Beijing, 100032
Beijing Tongren Hospital
Beijing, 100730
The Second Hospital of Jilin University
Changchun, 130041
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou
Shanghai First People's Hospital
Shanghai, 200080
Tianjin Medical University Eye Hospital
Tianjin, 300070
Eye Hospital, Wenzhou Medical University
Wenzhou, 325027
Ren Min Hospital Affiliated Wu Han University
Wuhan, 430060
South Korea9 sites
Pusan National University Hospital
Busan, 49241
Yeungnam University Medical Center
Daegu, 42415
Ajou University Medical Center
Gyeonggi-do, 16499
Seoul National University Bundang Hospital
Seongnam-si, 13605
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul St Mary's Hospital
Seoul, 06591
Kim's Eye Hospital
Seoul, 07301
Israel7 sites
Rambam Medical Center
Haifa, 3109601
Hadassah MC
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Rabin MC
Petah Tikva, 4941492
Kaplan Medical Center
Rehovot, 7660101
Tel Aviv Sourasky MC
Tel Aviv, 6423906
Assuta Hashalom Medical Center
Tel Aviv, 6789140
United Kingdom7 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Bradford Royal Infirmary
Bradford, BD9 6RJ
Bristol Eye Hospital
Bristol, BS1 2LX
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, GL1 3NN
Royal Liverpool University Hospital
Liverpool, L7 8XP
Western Eye Hospital
London, NW1 5QH
James Cook Hospital
Middlesbrough, TS4 3BW
Poland5 sites
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501
SPSK nr 1 w Lublinie
Lublin, 20-079
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, 53-334
Brazil4 sites
Fiocruz - Fundação Oswaldo Cruz
Rio de Janeiro, 21040-360
Retina Clinic
São Paulo, São Paulo, 01427-002
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo, 04023-062
CEMAPE - Centro Médico
São Paulo, São Paulo, 04084-002
Italy4 sites
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132
Asst Fatebenefratelli Sacco
Milan, Lombardy, 20157
ASL 4 SSR Ospedale Santa Maria di Montallegro
Rapallo, Liguria, 16035
AUSL ? IRCCS Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100
Austria3 sites
LKH-Univ.Klinikum Graz
Graz, 8036
Kepler Universitätskliniken GmbH - Med Campus III
Linz, 4021
Medizinische Universitat Wien
Vienna, 1090
Canada3 sites
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4
CHU de Quebec-Universite Laval
Québec, G1S 4L8
Kensington Vision and Research Centre
Toronto, Ontario, M5T 3A9
Portugal3 sites
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, 3000-548
Instituto de Oftalmologia Dr. Gama Pinto
Lisbon, 1169-019
Hospital de Santa Maria
Lisbon, 1649-035
Taiwan3 sites
Taipei Veterans General Hospital
Taipei, 11217
Mackay Memorial Hospital
Taipei
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
Netherlands2 sites
Het Oogziekenhuis Rotterdam
Rotterdam, 3011 BH
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Mexico1 site
Hospital de la Ceguera APEC
Mexico City, Mexico CITY (federal District), 04030
About this study
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
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
- Conditions
- Uveitic Macular Edema
- Being tested
- Vamikibart, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VamikibartDrug
Also called RO7200220
Participants will receive vamikibart IVT injection
ShamOther
Participants will receive a sham procedure that mimics an IVT injection.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Drug: Vamikibart |
| Arm B | Experimental | Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. Receives: Drug: Vamikibart |
| Arm C | Sham comparator | Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Measured: Week 16
Secondary outcomes (22)
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Measured: Week 20
Change from baseline in BCVA at Week 16
Measured: Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Measured: Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Measured: Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Measured: Weeks 20 and 52
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
Measured: Weeks 16 and 52
Time to rescue treatment
Measured: Up to Week 52
Number of rescue treatments received
Measured: Up to Week 52
Type of rescue treatments received
Measured: Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Measured: Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Measured: Weeks 16 and 52
Number of PRN injections received
Measured: Up to Week 52
Time to first PRN injection
Measured: Up to Week 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Measured: Weeks 16 and 52
Percentage of participants with ocular adverse events (AEs)
Measured: Up to Week 52
Percentage of participants with non-ocular AEs
Measured: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 24
Measured: Week 24
Percentage of participants with adverse events of special interest (AESIs)
Measured: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Measured: Week 52
Aqueous humor (AH) concentration of vamikibart
Measured: Up to Week 52
Serum concentration of vamikibart
Measured: Up to Week 52
Anti-drug antibody titer to vamikibart
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start9 Jan 2023
- Primary completion9 Dec 2024
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642312
- Sponsor's protocol ID
- GR44277
- Other IDs
- 2022-501793-19-00
- Acronym
- Meerkat
- Status last verified
- Nov 2025
- First submitted
- 6 Dec 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05642312
- Acronym / sponsor ID
- Meerkat / GR44277
- Conditions
- Uveitic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: VamikibartParticipants 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. |
| Arm B | Experimental | Drug: VamikibartParticipants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. |
| Arm C | Sham comparator | Other: ShamParticipants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VamikibartAlso: RO7200220Participants will receive vamikibart IVT injection | Drug | Arm A, Arm B |
| ShamParticipants will receive a sham procedure that mimics an IVT injection. | Other | Arm C |
Primary outcome
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Time frame: Week 16
22 secondary outcomes
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Time frame: Week 20
Change from baseline in BCVA at Week 16
Time frame: Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Time frame: Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Time frame: Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Time frame: Weeks 20 and 52
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
Time to rescue treatment
Time frame: Up to Week 52
Number of rescue treatments received
Time frame: Up to Week 52
Type of rescue treatments received
Time frame: Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Time frame: Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Time frame: Weeks 16 and 52
Number of PRN injections received
Time frame: Up to Week 52
Time to first PRN injection
Time frame: Up to Week 52
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
Percentage of participants with ocular adverse events (AEs)
Time frame: Up to Week 52
Percentage of participants with non-ocular AEs
Time frame: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 24
Time frame: Week 24
Percentage of participants with adverse events of special interest (AESIs)
Time frame: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Time frame: Week 52
Aqueous humor (AH) concentration of vamikibart
Time frame: Up to Week 52
Serum concentration of vamikibart
Time frame: Up to Week 52
Anti-drug antibody titer to vamikibart
Time frame: Baseline to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
77 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vamikibart in people with Uveitic Macular Edema, run by Hoffmann-La Roche at 77 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, China, South Korea, Israel, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.