150 Participants Needed

KHK4951 for Diabetic Macular Edema

Recruiting at 96 trial locations
TK
KK
KL
Overseen ByKetan Laud
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does list certain eye treatments that should not have been used recently. It's best to discuss your specific medications with the trial team.

What safety data exists for aflibercept in treating macular edema?

Aflibercept has been studied for safety in treating macular edema related to central retinal vein occlusion, and it is generally considered safe in clinical practice. The research indicates that it is well-tolerated by patients, with safety data supporting its use in this condition.12345

What data supports the effectiveness of the drug KHK4951 for Diabetic Macular Edema?

Research shows that ziv-aflibercept, a component of KHK4951, is effective in treating macular edema (swelling in the eye) related to branch retinal vein occlusion, suggesting potential benefits for similar eye conditions like diabetic macular edema.12678

Who Is on the Research Team?

ST

Sotaro Takigawa

Principal Investigator

Kyowa Kirin Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for patients with Diabetic Macular Edema (DME) who have a certain level of central retinal thickness and visual acuity, controlled diabetes (HbA1c ≤ 11%), and no history of severe eye conditions or treatments that could affect the study's outcome.

Inclusion Criteria

Voluntary written informed consent to participate in the study
500 μm ≥ CST ≥ 325 μm in the study eye at screening
BCVA ETDRS letter score of 73 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
See 1 more

Exclusion Criteria

My study eye shows signs of worsening diabetic eye disease.
I have had rubeosis in my eye being studied.
My glaucoma in one eye is not under control.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KHK4951 eye drops at varying doses to assess efficacy and safety

8 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aflibercept Injection
  • KHK4951
Trial Overview The trial is testing KHK4951 eye drops against Aflibercept injections to see which one is better at treating DME. Patients will be closely monitored to measure the effectiveness and safety of the KHK4951 treatment.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment2 Interventions
Group II: Arm BExperimental Treatment2 Interventions
Group III: Arm AExperimental Treatment2 Interventions

KHK4951 is already approved in United States, European Union for the following indications:

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Approved in United States as FOTIVDA for:
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Approved in European Union as Fotivda for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kyowa Kirin, Inc.

Lead Sponsor

Trials
49
Recruited
5,700+

Kyowa Kirin Co., Ltd.

Lead Sponsor

Trials
181
Recruited
28,800+
Takeyoshi Yamashita profile image

Takeyoshi Yamashita

Kyowa Kirin Co., Ltd.

Chief Medical Officer since 2024

Not available

Masashi Miyamoto profile image

Masashi Miyamoto

Kyowa Kirin Co., Ltd.

Chief Executive Officer

PhD in Molecular Biology

Published Research Related to This Trial

In a study of 35 patients over 24 months, intravitreal bevacizumab (IVB) treatment led to complete resolution of macular edema in 34.3% of cases, indicating its efficacy in managing this condition due to branch retinal vein occlusion (BRVO).
While visual acuity improved significantly in 23% of patients, a median of six injections was needed to achieve and maintain these benefits, highlighting the need for ongoing treatment and further research to compare IVB with other therapies.
Twenty-Four-Month Results of Intravitreal Bevacizumab in Macular Edema Secondary to Branch Retinal Vein Occlusion.Tsagkataki, M., Papathomas, T., Lythgoe, D., et al.[2016]
Intravitreal ranibizumab (IVR) 0.5 mg significantly improved visual acuity and reduced central foveal thickness compared to non-anti-VEGF treatments, with a notable increase in patients gaining 15 or more letters on the ETDRS scale after six months.
IVR 0.3 mg was found to be equally effective as IVR 0.5 mg in treating macular edema secondary to retinal vein occlusion, indicating that a lower dose may be sufficient for similar therapeutic outcomes.
Ranibizumab for macular edema secondary to retinal vein occlusion: a meta-analysis of dose effects and comparison with no anti-VEGF treatment.Song, WT., Xia, XB.[2022]
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.
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]

Citations

Twenty-Four-Month Results of Intravitreal Bevacizumab in Macular Edema Secondary to Branch Retinal Vein Occlusion. [2016]
Ranibizumab for macular edema secondary to retinal vein occlusion: a meta-analysis of dose effects and comparison with no anti-VEGF treatment. [2022]
Short-term outcomes in patients with branch retinal vein occlusion who received intravitreal aflibercept with or without intravitreal ranibizumab. [2020]
Intravitreal bevacizumab for macular oedema secondary to branch retinal vein occlusion. [2015]
Bevacizumab versus ziv-aflibercept in branch retinal vein occlusion. [2020]
Aflibercept: newly approved for the treatment of macular edema following central retinal vein occlusion. [2022]
Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes. [2022]
A randomised, double-masked, controlled study of the efficacy and safety of intravitreal bevacizumab versus ranibizumab in the treatment of macular oedema due to branch retinal vein occlusion: MARVEL Report No. 1. [2022]
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