Vamikibart for Uveitic Macular Edema

(Sandcat Trial)

Recruiting in Palo Alto (17 mi)

+152 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used certain eye treatments like IVT biologics, Methotrexate, or specific implants within a certain period before the trial starts.

What data supports the idea that Vamikibart for Uveitic Macular Edema is an effective treatment?

The available research does not provide specific data on Vamikibart for Uveitic Macular Edema. Instead, it focuses on other treatments for different types of macular edema, such as aflibercept and pegaptanib, which are used for conditions like branch retinal vein occlusion. Without direct data on Vamikibart, we cannot conclude its effectiveness for Uveitic Macular Edema based on the provided information. ^{1 2 3 4 5}

What safety data is available for Vamikibart (RO7200220) in treating uveitic macular edema?

The provided research does not contain any safety data for Vamikibart (RO7200220) or its other names (RG-6179, RO-7200220) in the treatment of uveitic macular edema. The studies focus on other treatments for macular edema, such as ranibizumab, aflibercept, conbercept, and fingolimod, but do not mention Vamikibart. ^{3 6 7 8 9}

Is the drug Vamikibart a promising treatment for Uveitic Macular Edema?

The information provided does not directly mention Vamikibart or its effects on Uveitic Macular Edema. Therefore, we cannot determine if Vamikibart is a promising treatment for this condition based on the given research articles. ^{5 10 11 12 13}

Eligibility Criteria

This trial is for women with uveitic macular edema, which causes swelling in the eye. They must have a certain level of vision impairment and agree to use contraception or abstain from sex. Those with recent major eye surgeries, infections like syphilis or tuberculosis, HIV, uncontrolled glaucoma, or who've used certain medications recently can't join.

Inclusion Criteria

I have swelling in the eye due to non-infectious inflammation.

BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

I agree to follow the study's rules on abstinence or contraception.

Exclusion Criteria

I have swelling in the back of my eye not caused by inflammation.

I have no eye conditions blocking the view or imaging of my retina.

I have a serious ongoing health or mental health condition.

Treatment Details

Interventions

• RO7200220 (Unknown)

Trial Overview The study tests Vamikibart's effectiveness and safety against uveitic macular edema compared to a sham treatment (placebo). Participants will be randomly assigned to receive either Vamikibart or the sham intervention to see if there's an improvement in their condition.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

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

Group II: Arm A Experimental Treatment 1 Intervention

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.

Group III: Arm C Placebo Group 1 Intervention

Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Associated Retina Consultants Phoenix, AZ

Retina Consultants of Orange County Fullerton, CA

Retina Group of Washington Chevy Chase, MD

Retina Consultants of Texas The Woodlands, TX

More Trial Locations

Who Is Running the Clinical Trial?

Hoffmann-La Roche Lead Sponsor

References

1. Japan pubmed.ncbi.nlm.nih.gov

Twenty-four-month results of intravitreal aflibercept for macular edema due to branch retinal vein occlusion. [2021] To investigate 24-month results of intravitreal aflibercept (IVA) for macular edema due to branch retinal vein occlusion (BRVO-ME).

2. New Zealand pubmed.ncbi.nlm.nih.gov

Intravitreal pegaptanib for refractory macular edema secondary to retinal vein occlusion. [2021] To assess the efficacy of intravitreal Pegaptanib sodium (Macugen(®)) injection in the management of refractory macular edema secondary to branch retinal vein occlusion.

3. United States pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept for macular edema following branch retinal vein occlusion: the 24-week results of the VIBRANT study. [2022] To compare the efficacy and safety of intravitreal aflibercept injection (IAI) with macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion (BRVO).

4. United States pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. [2022] To evaluate intravitreal aflibercept injections (IAI; also called VEGF Trap-Eye) for patients with macular edema secondary to central retinal vein occlusion (CRVO).

5. England pubmed.ncbi.nlm.nih.gov

Dynamics of soluble vascular endothelial growth factor receptors and their ligands in aqueous humour during ranibizumab for age-related macular degeneration. [2022] Intravitreal ranibizumab injection (IRI) is effective for patients with exudative age-related macular degeneration (AMD) and decreases intraocular levels of vascular endothelial growth factor (VEGF), but VEGF receptor intraocular dynamics after IRI are unclear. Therefore, we evaluated changes in the aqueous humor levels of soluble vascular endothelial growth factor receptor (sVEGFR)-1, sVEGFR-2, and their ligands for these receptors (VEGF) patients with AMD receiving IRI.

6. England pubmed.ncbi.nlm.nih.gov

Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis). [2016] To evaluate the recurrence of macular edema (ME) in a mixed group of patients with branch (BRVO) and central (CRVO) retinal vein occlusion after early onset treatment with intravitreal injections of ranibizumab.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Short-term outcomes in patients with branch retinal vein occlusion who received intravitreal aflibercept with or without intravitreal ranibizumab. [2020] The purpose of this study was to determine the short-term outcomes for patients who received intravitreal aflibercept (IVA) with or without intravitreal ranibizumab (IVR) for macular edema (ME) due to branch retinal vein occlusion (BRVO).

8. China pubmed.ncbi.nlm.nih.gov

Comparison of intravitreal injection of conbercept and triamcinolone acetonide for macular edema secondary to branch retinal vein occlusion. [2020] To compare the safety and efficacy of the intravitreal injection of conbercept (IVC) and triamcinolone acetonide (IVTA) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

9. Germany pubmed.ncbi.nlm.nih.gov

[Early onset of fingolimod-associated macular edema]. [2019] Fingolimod, a disease-modifying sphingosine 1‑phosphate receptor modulator, which was approved in Germany in 2011, decreases the relapse rate and reduces neuroinflammation in patients with relapsing-remitting multiple sclerosis. Macular edema is a well-known ocular side effect of fingolimod therapy. Specific intervals for ophthalmologic check-ups after starting fingolimod and definite treatment schedules for fingolimod-associated macular edema are, however, still lacking.

10. Netherlands pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. [2023] Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO).

11. England pubmed.ncbi.nlm.nih.gov

Aflibercept for the treatment of diabetic macular edema. [2022] Diabetic macular edema (DME) is an accumulation of fluid in the central retina, secondary to vascular-leakage from diabetic vascular damage. DME and other ophthalmic sequela of diabetes are the leading cause of blindness in 20 to 74-year-olds. The development of VEGF-inhibitors (anti-VEGF) has revolutionized DME treatment improving the clinician's ability to remove excess fluid from the macula, improving visual-acuity. Aflibercept is an anti-VEGF agent made of a recombinant fusion protein (consisting of VEGF receptors 1 and 2 extracellular domains) fused with the Fc-portion of human-IgG1, which binds both VEGF isoforms A and B, and placental growth factor. Phase III clinical trials and published scientific studies have demonstrated the efficacy of intravitreal aflibercept injection in the treatment of DME.

12. England pubmed.ncbi.nlm.nih.gov

Effects of intravitreal injection of ranibizumab and aflibercept for branch retinal vein occlusion on the choroid: a retrospective study. [2022] Macular edema is found in more than half of branch retinal vein occlusion (BRVO) cases, leading to visual loss in most of these cases. Intravitreal injection of anti-vascular endothelial growth factor is currently the standard treatment for macular edema due to BRVO (BRVO-ME). The difference in the effects of aflibercept and ranibizumab on the choroid in BRVO-ME is unknown. Therefore, we analyzed the effects of intravitreal injection of ranibizumab and aflibercept on BRVO-ME.

13. England pubmed.ncbi.nlm.nih.gov

Aqueous soluble vascular endothelial growth factor receptor-2 in macular edema with branch retinal vein occlusion. [2013] The aqueous humor level of soluble vascular endothelial growth factor receptor (sVEGFR)-2 may influence macular edema in patients with branch retinal vein occlusion (BRVO). The association of sVEGFR-2 with macular edema was investigated in this study.