Vamikibart for Uveitic Macular Edema

(Sandcat Trial)

Recruiting at 152 trial locations

Overseen By Reference Study ID Number: GR44278 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: IVT biologics, Anti-VEGFs

Disqualifiers: Syphilis, Tuberculosis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 48 weeks

256 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it does mention that certain eye treatments like specific injections or implants should not have been used recently. It's best to discuss your current medications with the trial team to see if they are allowed.

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}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-LaRoche

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 intravitreal injections every 4 weeks up to Week 12, followed by as-needed dosing from Week 20 to Week 48

48 weeks

4 visits (in-person) for initial injections, followed by PRN visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RO7200220

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.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Intravitreal aflibercept (IVA) treatment for macular edema due to branch retinal vein occlusion (BRVO-ME) showed significant improvements in best corrected visual acuity and central foveal thickness over 24 months, with a remission rate of 87.5%.

Patients required fewer injections over time, averaging 2.2 injections in the first year and only 0.4 in the second year, suggesting that early treatment may help reduce the need for additional injections later on.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-four-month results of intravitreal aflibercept for macular edema due to branch retinal vein occlusion. Sakanishi, Y., Yasuda, K., Morita, S., et al.[2021]

In a study involving five patients with refractory macular edema due to branch retinal vein occlusion, treatment with intravitreal Pegaptanib sodium resulted in significant improvements in both visual acuity and macular edema after three months.

The findings suggest that Pegaptanib sodium is a safe and effective option for patients who do not respond to other treatments like bevacizumab or triamcinolone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal pegaptanib for refractory macular edema secondary to retinal vein occlusion. Udaondo, P., Garcia-Delpech, S., Salom, D., et al.[2021]

In a phase III trial involving 183 treatment-naïve eyes with macular edema after branch retinal vein occlusion, intravitreal aflibercept injection (IAI) resulted in a significantly higher proportion of patients gaining 15 or more letters in visual acuity compared to macular grid laser treatment (52.7% vs. 26.7%).

IAI also led to a greater mean improvement in visual acuity (17.0 letters vs. 6.9 letters) and a more substantial reduction in central retinal thickness (280.5 μm vs. 128.0 μm) at 24 weeks, with minimal serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept for macular edema following branch retinal vein occlusion: the 24-week results of the VIBRANT study. Campochiaro, PA., Clark, WL., Boyer, DS., et al.[2022]

In a study of 189 patients with macular edema due to central retinal vein occlusion, those receiving monthly intravitreal aflibercept injections showed a significant improvement in visual acuity, with 56.1% gaining at least 15 letters on the ETDRS scale by week 24 compared to only 12.3% in the sham group.

The benefits of aflibercept were sustained through week 52, with a mean gain of 16.2 letters for the treatment group versus 3.8 letters for the sham group, and the treatment was generally well tolerated with common side effects including conjunctival hemorrhage and increased intraocular pressure.

NCBI (Pubmed)

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. Brown, DM., Heier, JS., Clark, WL., et al.[2022]

In a study of 24 patients with age-related macular degeneration (AMD) receiving three monthly intravitreal ranibizumab injections, significant improvements in best corrected visual acuity and central macular thickness were observed, indicating the treatment's efficacy.

The treatment led to a notable decrease in intraocular levels of VEGF, PlGF, and sVEGFR-1, suggesting that ranibizumab works by suppressing these factors involved in AMD pathogenesis.

NCBI (Pubmed)

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. Motohashi, R., Noma, H., Yasuda, K., et al.[2022]

In a study of 40 patients with retinal vein occlusion treated with ranibizumab, 100% of patients with central retinal vein occlusion (CRVO) experienced recurrence of macular edema (ME), compared to 59% in those with branch retinal vein occlusion (BRVO).

Recurrences of ME occurred sooner and lasted longer in the CRVO group, with a mean interval of 1.2 months between injections, compared to 2.4 months for the BRVO group, highlighting the need for closer monitoring and potentially more aggressive treatment in CRVO patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis). Karagiannis, DA., Karampelas, MD., Soumplis, VM., et al.[2016]

Intravitreal aflibercept (IVA) significantly reduced central macular thickness and improved best-corrected visual acuity in patients with macular edema due to branch retinal vein occlusion, regardless of whether they were treatment-naïve or switched from ranibizumab.

Both treatment groups showed positive outcomes at 1 week and 1 month post-injection, indicating that IVA is an effective short-term treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term outcomes in patients with branch retinal vein occlusion who received intravitreal aflibercept with or without intravitreal ranibizumab. Sakanishi, Y., Usui-Ouchi, A., Tamaki, K., et al.[2020]

Intravitreal injection of conbercept (IVC) significantly improved best corrected visual acuity (BCVA) and reduced central retinal thickness (CRT) more effectively than triamcinolone acetonide (IVTA) over a 12-month period, with a notable improvement in BCVA of 27.31 letters in the IVC group compared to 13.53 letters in the IVTA group.

Patients receiving IVTA experienced a higher risk of elevated intraocular pressure and cataract progression, with 64.71% of IVTA patients showing new-onset or progression of cataracts compared to only 19.44% in the IVC group, indicating a better safety profile for IVC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intravitreal injection of conbercept and triamcinolone acetonide for macular edema secondary to branch retinal vein occlusion. Zhao, M., Zhang, C., Chen, XM., et al.[2020]

Fingolimod, an effective treatment for relapsing-remitting multiple sclerosis, can cause macular edema, as demonstrated in a case where a 45-year-old patient experienced visual impairment one month after starting the medication.

The macular edema was successfully treated with topical and oral medications after discontinuing fingolimod, highlighting the importance of regular ophthalmologic check-ups every 4 weeks for the first 3 months of treatment to monitor for this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early onset of fingolimod-associated macular edema]. Schelenz, D., Kleiter, I., Schöllhammer, J., et al.[2019]

The phase III BALATON/COMINO trials will assess the efficacy and safety of faricimab in treating diabetic macular edema due to retinal vein occlusion, involving 1282 patients across 22 countries.

Faricimab is being compared to aflibercept using a personalized treatment approach that adjusts dosing intervals based on individual patient responses, aiming to demonstrate noninferiority in visual acuity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. Hattenbach, LO., Abreu, F., Arrisi, P., et al.[2023]

Diabetic macular edema (DME) is a major cause of blindness in younger adults, resulting from fluid accumulation in the retina due to diabetic vascular damage.

Aflibercept, an anti-VEGF treatment, has been shown in Phase III clinical trials to effectively reduce fluid in the macula and improve visual acuity in patients with DME.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept for the treatment of diabetic macular edema. Harkins, KA., Haschke, M., Do, DV.[2022]

In a study of 36 patients with macular edema due to branch retinal vein occlusion (BRVO-ME), both ranibizumab and aflibercept showed similar effects on choroidal thickness over a 12-month period, indicating comparable efficacy in treating this condition.

The changes in central macular thickness and subfoveal choroidal thickness were not significantly different between the two treatments, suggesting that both anti-VEGF injections are equally effective for managing BRVO-ME.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intravitreal injection of ranibizumab and aflibercept for branch retinal vein occlusion on the choroid: a retrospective study. Kishishita, S., Sakanishi, Y., Morita, S., et al.[2022]

In a study of 22 patients with branch retinal vein occlusion (BRVO) and macular edema, levels of soluble vascular endothelial growth factor receptor (sVEGFR)-2 in the aqueous humor were significantly higher compared to a control group, indicating a potential role in the disease process.

The elevated sVEGFR-2 levels were correlated with the severity of macular edema, suggesting that measuring these levels could provide insights into the condition's status in BRVO patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous soluble vascular endothelial growth factor receptor-2 in macular edema with branch retinal vein occlusion. Noma, H., Mimura, T.[2013]

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]

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

Intravitreal pegaptanib for refractory macular edema secondary to retinal vein occlusion. [2021]

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]

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]

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]

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

Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis). [2016]

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]

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]

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

[Early onset of fingolimod-associated macular edema]. [2019]

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]

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

Aflibercept for the treatment of diabetic macular edema. [2022]

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]

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

Aqueous soluble vascular endothelial growth factor receptor-2 in macular edema with branch retinal vein occlusion. [2013]