A clinical study to investigate how well RO7200220 improves vision compared to a placebo treatment in people with inflammation-related fluid swelling in the eye (uveitic macular edema, UME) and how safe RO7200220 is at different doses.
Summary description of the study
This clinical study will recruit individuals diagnosed with uveitis who have developed an UME not caused by an infection (non-infectious uveitis, NIU). The aim of this clinical study is to compare the positive or negative effects of treatment with RO7200220 with a placebo treatment (where no active treatment is administered). Individuals with UME participating in this clinical study will receive either RO7200220 by injection into the eye or the placebo treatment. The placebo treatment feels like a real injection, but no needle is inserted into the eye, and nothing is injected into the eye. Each participant will receive the study treatment in one eye ("study eye"). Participants will receive RO7200220 OR a placebo treatment every 4 weeks for the first 12 weeks. After week 12, participants will continue to be examined every 4 weeks by a study doctor. No treatment will be administered in week 16. The study treatment (RO7200220 OR placebo treatment) will be administered as needed from week 20 to week 48. Study participants will undergo a final assessment at week 52 and then continue their usual care with their doctor. Overall, participants will complete about 15 study visits, which corresponds to a total study duration of about 1 year. During hospital visits, it will be checked how participants respond to the treatment and what side effects they may have. The primary outcome of the study, measured to determine whether the drug works, is how many participants show an improvement of at least 15 letters on a vision test after 16 weeks - compared to the start of the study. Other important endpoints of the study include assessing the change in vision since the start of the study and the change in the amount of retinal fluid swelling.
(BASEC)
Intervention under investigation
All participants in this clinical study will be randomly assigned to three groups (with an equal chance of receiving one of the three treatment regimens - a 1 in 3 chance of being assigned to one of the groups) and will receive either
- RO7200220 at a dose of 1.0 mg or
- RO7200220 at a dose of 0.25 mg or
- a placebo treatment.
Participants will remain in the same treatment group and cannot switch groups during the study. The clinical study is divided into two parts:
• Part 1 (Day 1 to Week 12): Participants will receive every 4 weeks for a total of 4 treatments either RO7200220 (Groups A and B) or a placebo treatment (Group C) in the study eye
• Part 2 (Week 20 to Week 48): Participants will receive RO7200220 (Groups A and B) or a placebo treatment (Group C) in the study eye if the study doctor decides that treatment is necessary. From week 4, the study doctor may recommend that participants discontinue the clinical study treatment if their vision or the UME/uveitis worsens, and receive another treatment for UME (called "rescue treatment"). The rescue treatment is a treatment that is not part of the study and is part of standard care; the type of treatment will be determined by the study doctor. In the case of rescue treatment, participants will not receive any further treatment with RO7200220 OR placebo medications. Participants may continue to be examined every 4 weeks by the clinical study doctor until the end of the study, but they may also withdraw from the study at any time.
This is a double-blind study, meaning that neither the participant nor the clinical study doctor can choose or know which group the participant is in until the study is completed, to avoid bias and expectations regarding the outcomes. However, the clinical trial doctor for the participant may find out which group the participant is in if their safety is at risk.
(BASEC)
Disease under investigation
Uveitic macular edema (UME, or 'UMO' or retinal swelling or cystoid edema) is a common complication of inflammation inside the eye (known as 'uveitis'). The UME is caused by a buildup of fluid in a delicate layer at the back of the eye, the retina, which affects vision and can lead to eye damage.
(BASEC)
This study is open to individuals who are at least 18 years old and who are willing to sign the informed consent form. Participants must meet the following study eye criteria to participate in the study: • Diagnosis of macular edema associated with non-infectious uveitis (NIU), defined as macular thickening. • Diagnosis of active or quiescent, acute or chronic non-infectious uveitis of any etiology and any anatomical type (anterior, medial, posterior, panuveitis) based on investigator's judgement. • A best-corrected visual acuity with a letter value of 73 to 19 letters. • Sufficiently clear ocular media and sufficient pupil dilation to allow high-quality retinal imaging to confirm UME diagnosis. (BASEC)
Exclusion criteria
Individuals may not be able to participate in this study if they have certain other medical conditions, including eye diseases, that make the study unsuitable for them, if they are currently receiving or have previously received certain treatments, if they are pregnant or breastfeeding, or if they have a planning pregnancy. Participants who are currently participating or have participated in any other clinical study (including a study using RO7200220 intravitreal injection (IVT) in either eye) must not participate in the study within three months prior to the first day. Other exclusion criteria include: • Diagnosis of macular edema from a cause other than non-infectious uveitis • Any serious eye disease that may require medical or surgical intervention during the study period to prevent vision loss (BASEC)
Trial sites
Bern, Lausanne, Zurich, Other
(BASEC)
Binningen
(BASEC)
Sponsor
F. Hoffmann-La Roche Ltd.
(BASEC)
Contact
Contact Person Switzerland
Lena Baumgartner
+41 61 715 42 76
switzerland.clinical-research@clutterroche.comRoche Pharma (Schweiz) AG
(BASEC)
General Information
Hoffmann-LaRoche
(ICTRP)
Scientific Information
Hoffmann-LaRoche
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
27.07.2023
(BASEC)
ICTRP Trial ID
NCT05642325 (ICTRP)
Official title (approved by ethics committee)
SANDCAT - EINE MULTIZENTRISCHE, RANDOMISIERTE, DOPPELT-MASKIERTE, SCHEINKONTROLLIERTE PHASE-III-STUDIE ZUR UNTERSUCHUNG DER WIRKSAMKEIT, SICHERHEIT, PHARMAKOKINETIK UND PHARMAKODYNAMIK VON INTRAVITREAL VERABREICHTEM RO7200220 BEI PATIENTEN MIT UVEITISCHEM MAKULAÖDEM (BASEC)
Academic 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 (ICTRP)
Public title
Vamikibart in Participants With Uveitic Macular Edema (ICTRP)
Disease under investigation
Uveitic Macular Edema (ICTRP)
Intervention under investigation
Drug: VamikibartOther: Sham (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Inclusion/Exclusion 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 (ICTRP)
not available
Primary and secondary end points
Proportion of participants with = 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 (ICTRP)
Proportion of participants with = 15 letter improvement from baseline in BCVA at Week 20;Change from baseline in BCVA at Week 16;Change from baseline in central subfield thickness (CST) at Week 16;Change from Baseline in BCVA at Weeks 20 and 52;Change from baseline in CST at 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 to rescue treatment;Number of rescue treatments received;Type of rescue treatments received;Proportion of participants with =15 letter improvement from baseline in BCVA at Week 16 and 52;Proportion of participants without =15 letter loss from baseline in BCVA at Week 16 and 52;Time to first PRN injection;Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52;Percentage of participants with ocular adverse events (AEs);Percent change from baseline in corneal endothelial cell density at Week 24;Percentage of participants with non-ocular AEs;Percentage of participants with adverse events of special interest (AESIs);Percent change from baseline in corneal endothelial cell density at Week 52;Aqueous humor (AH) concentration of vamikibart;Serum concentration of vamikibart;Anti-drug antibody titer to vamikibart (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Clinical Trials, Hoffmann-LaRoche (ICTRP)
Secondary trial IDs
GR44278 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05642325 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available