Vabysmo for Diabetic Retinopathy

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must not be taking: Ocular anti-VEGF

Disqualifiers: Pregnancy, Glaucoma, Uveitis, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using any ocular anti-VEGF treatments, you must stop them at least 3 months before starting the trial.

What data supports the effectiveness of the drug Vabysmo (Faricimab) for treating diabetic retinopathy?

Research shows that Faricimab, marketed as Vabysmo, has been effective in improving vision and reducing retinal thickness in patients with diabetic macular edema, a condition related to diabetic retinopathy. In clinical trials, Faricimab demonstrated similar or better results compared to other treatments, with fewer injections needed, indicating its potential effectiveness for diabetic retinopathy. ^{1 2 3 4 5}

Is Vabysmo (Faricimab) safe for humans?

Vabysmo (Faricimab) has been studied in several clinical trials for conditions like diabetic macular edema and neovascular age-related macular degeneration, showing a good safety profile. These studies indicate that it is generally safe for human use, with safety data supporting its approval in the USA and Japan. ^{1 2 3 6 7}

What makes the drug Vabysmo unique for treating diabetic retinopathy?

Vabysmo (faricimab) is unique because it is a bispecific antibody that targets two key factors involved in eye disease: VEGF-A and Ang-2, potentially allowing for longer intervals between injections and reducing treatment burden compared to traditional therapies. ^{1 2 3 8 9}

What is the purpose of this trial?

In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.

Eligibility Criteria

This trial is for adults over 18 with non-clearing vitreous hemorrhage due to diabetic retinopathy, who are undergoing eye surgery. They must be able to follow the study plan and use effective contraception if of childbearing potential. Those unable to commit or at risk of not complying with contraceptive guidelines are excluded.

Inclusion Criteria

I have a severe eye condition due to diabetes and need surgery.

Exclusion Criteria

General exclusion criteria: Known hypersensitivity to components in the faricimab injection, dilating eye drops, disinfectants, anesthetics, or antimicrobial preparations used during the study, History of diseases or conditions contraindicating the use of faricimab, Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab. Women of childbearing potential must have negative pregnancy tests at specified time points.

My study eye has not had recent treatments or surgeries, and only has diabetic retinopathy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peri-operative faricimab or sham injection to evaluate efficacy in limiting complications from pars plana vitrectomy

6 months

Intra-operative and post-operative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including BCVA outcomes and rates of post-operative complications

12 months

Regular follow-up visits

Treatment Details

Interventions

• Faricimab

Trial Overview The study tests whether Vabysmo (Faricimab) injections before eye surgery can reduce complications compared to a sham treatment in patients with diabetic-related bleeding in the eye. Participants will be randomly assigned to receive either the real drug or a placebo.

Participant Groups

Group I: Faricimab injection Experimental Treatment 1 Intervention

Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The 6-mg dose of faricimab will be administered by IVT at the study site to patients. A specified filter needle must be used for each dose preparation of faricimab according to the instructions provided in the Investigator's Brochure and package insert. No other material than specified should be used. Vials of faricimab drug product are for a single-dose only (one injection preparation per patient per eye). Vials used for one patient must not be used for any other patient. Partially used vials, remaining faricimab drug product, as well as administration material must not be reused.

Group II: Sham injection Placebo Group 1 Intervention

Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The sham procedure mimics an intravitreal injection of faricimab except that the blunt end of an empty syringe is pressed against an anesthetized eye instead of a needle attached to a faricimab-filled syringe.

Faricimab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)
• Macular edema following retinal vein occlusion (RVO)

Approved in European Union as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

Approved in Canada as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

Faricimab, a dual-target antibody for VEGF-A and Ang-2, has shown comparable efficacy to monthly ranibizumab in treating neovascular age-related macular degeneration, allowing for longer intervals between injections and fewer treatments overall.

In the BOULEVARD trial, faricimab significantly improved diabetic retinopathy severity in 38.6% of patients treated with the highest dose, outperforming ranibizumab, indicating its potential for effective long-term management of diabetic macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faricimab: from research to clinical practice]. Yusef, YN., Budzinskaya, MV., Plyukhova, AA.[2023]

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]

Faricimab is a bispecific antibody that targets both VEGF-A and Ang-2, and it has been approved in the USA for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The drug is administered via intravitreal injection and is currently undergoing Phase III clinical trials for additional retinal vascular diseases, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faricimab: First Approval. Shirley, M.[2022]

Faricimab treatment in patients with neovascular age-related macular degeneration (nAMD) who did not respond to other anti-VEGF therapies resulted in significant anatomical improvements, including a reduction in central subfield thickness (CST) by 18µm and intraretinal/subretinal fluid height by 89µm after switching from previous treatments.

Despite the anatomical improvements, visual acuity remained stable after switching to faricimab, indicating that while the treatment effectively reduces fluid and swelling, it does not negatively impact vision in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faricimab Effectively Resolves Intraretinal Fluid and Preserves Vision in Refractory, Recalcitrant, and Nonresponsive Neovascular Age-Related Macular Degeneration. Cheng, AM., Joshi, S., Banoub, RG., et al.[2023]

In the phase 2 BOULEVARD trial involving 229 patients with diabetic macular edema, faricimab (6.0 mg) showed statistically significant improvements in visual acuity compared to ranibizumab, with an average gain of 3.6 ETDRS letters at week 24.

Faricimab also demonstrated greater reductions in central subfield thickness and longer time to re-treatment, indicating its potential for enhanced durability and efficacy in treating diabetic macular edema without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. Sahni, J., Patel, SS., Dugel, PU., et al.[2020]

Faricimab demonstrated significant improvements in best-corrected visual acuity (BCVA) for patients with diabetic macular edema, with similar efficacy observed in both Asian (average gain of +10.4 letters) and non-Asian (average gain of +11.1 letters) subgroups after one year.

The treatment was well tolerated with no new safety concerns, and a high percentage of patients in both groups achieved extended dosing intervals, indicating the durability of the treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. Ishida, S., Chen, SJ., Murata, T., et al.[2023]

Faricimab demonstrated significant improvements in best-corrected visual acuity (BCVA) in Japanese patients with diabetic macular edema (DME), with mean changes of +11.1 letters for Q8W dosing and +8.1 letters for personalized treatment intervals, comparable to the global results.

The treatment was well tolerated with no new safety concerns, and a majority of patients in the personalized treatment interval group were able to extend dosing to every 12 or 16 weeks, indicating durable efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. Shimura, M., Kitano, S., Ogata, N., et al.[2023]

In a study of 26 patients with neovascular age-related macular degeneration (nAMD), switching to intravitreal faricimab resulted in a significantly longer fluid-free interval compared to previous treatments with anti-VEGF agents, indicating improved efficacy.

No serious adverse events were reported, suggesting that faricimab is a safe option for patients who did not respond well to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal faricimab for neovascular age-related macular degeneration previously treated with traditional anti-VEGF compounds: a real-world prospective study. Grimaldi, G., Cancian, G., Rizzato, A., et al.[2023]

Faricimab, a bispecific antibody, showed non-inferior efficacy compared to aflibercept in improving best-corrected visual acuity in patients with neovascular age-related macular degeneration (nAMD) over two phase 3 trials involving 1329 patients.

The trials demonstrated that faricimab can be administered up to every 16 weeks, potentially reducing the treatment burden for patients while maintaining similar safety profiles to aflibercept, with comparable rates of ocular adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Heier, JS., Khanani, AM., Quezada Ruiz, C., et al.[2023]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Faricimab: from research to clinical practice]. [2023]

2. 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]

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

Faricimab: First Approval. [2022]

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

Faricimab Effectively Resolves Intraretinal Fluid and Preserves Vision in Refractory, Recalcitrant, and Nonresponsive Neovascular Age-Related Macular Degeneration. [2023]

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

Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. [2020]

6. China pubmed.ncbi.nlm.nih.gov

Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Intravitreal faricimab for neovascular age-related macular degeneration previously treated with traditional anti-VEGF compounds: a real-world prospective study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. [2023]