What is the mechanism of action of this treatment?

The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF agents and corticosteroids, both administered intravitreally. Anti-VEGF agents inhibit vascular endothelial growth factor, reducing abnormal blood vessel growth and leakage in the retina, thereby decreasing macular edema. Corticosteroids reduce inflammation and vascular permeability, which also helps in reducing edema. These treatments are crucial for DME patients as they directly target the underlying causes of macular edema, potentially improving vision and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Diabetic Macular Edema (DME) administered intravitreally include anti-VEGF agents such as ranibizumab and aflibercept, and corticosteroids like dexamethasone implants. Known side effects of these treatments include increased intraocular pressure, cataract formation, eye pain, floaters, and potential risk of endophthalmitis (eye infection). Additionally, corticosteroids may cause elevated intraocular pressure and glaucoma. These side effects should be monitored by an ophthalmologist to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several intravitreal treatments for Diabetic Macular Edema (DME). These include anti-VEGF (vascular endothelial growth factor) agents such as Ranibizumab (Lucentis), Aflibercept (Eylea), and Bevacizumab (Avastin). These drugs work by inhibiting the action of VEGF, a protein that promotes the growth of abnormal blood vessels in the retina, thereby reducing fluid leakage and swelling. Additionally, corticosteroids like Dexamethasone (Ozurdex) and Fluocinolone Acetonide (Iluvien) are also approved for intravitreal use to reduce inflammation and edema in the retina.

What other types of research exist?

Promising novel alternatives to Vamikibart for treating diabetic macular edema in 2024 include Faricimab, a bispecific antibody targeting both VEGF and Ang-2, which has shown positive results in clinical trials. Additionally, the Port Delivery System with Ranibizumab (PDS) offers a sustained-release mechanism for anti-VEGF therapy, reducing the frequency of intravitreal injections. Both treatments have demonstrated efficacy and safety in managing DME.

← Back to Search

Monoclonal Antibodies

RO7200220 for Diabetic Macular Edema

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Decreased visual acuity attributable primarily to DME

Diagnosis of diabetes mellitus (Type 1 or Type 2)

Must not have

Any proliferative diabetic retinopathy

Active intraocular or periocular infection or active intraocular inflammation in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests vamikibart, an eye injection, in people with diabetic macular edema. The medication aims to reduce swelling and improve vision by being injected directly into the eye.

Who is the study for?

This trial is for adults with diabetic macular edema, a condition causing swelling in the eye. Participants must have diabetes (Type 1 or Type 2), decreased vision due to DME, and agree to use effective contraception if applicable. They can't join if they've had certain treatments like anti-VEGF therapy recently, uncontrolled blood pressure, HbA1c >12%, are pregnant/breastfeeding, or have other eye conditions that affect vision.

What is being tested?

The study tests Vamikibart's effectiveness against diabetic macular edema compared to Ranibizumab and a sham procedure. It's double-masked meaning neither participants nor researchers know who gets which treatment. The trial lasts up to 76 weeks and includes safety assessments and checks on how the body processes the drug.

What are the potential side effects?

While specific side effects of Vamikibart aren't listed here, similar treatments often cause eye irritation or discomfort, increased intraocular pressure, bleeding inside the eye, cataract formation and sometimes infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My vision loss is mainly due to diabetic macular edema.

Select...

I have been diagnosed with diabetes (Type 1 or Type 2).

Select...

My diabetes has caused swelling in the center of my eye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a severe form of diabetic eye disease.

Select...

I have an active eye infection or inflammation in my study eye.

Select...

I have had laser treatment on my eye.

Select...

My blood pressure is not higher than 180/100 mmHg while resting.

Select...

I have no eye conditions affecting my central vision other than DME.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: 1.0 mg Vamikibart Q4WExperimental Treatment1 Intervention

Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.

Group II: Arm B: 1.0 mg Vamikibart Q8WExperimental Treatment2 Interventions

Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.

Group III: Arm A: 0.25 mg Vamikibart Q8WExperimental Treatment2 Interventions

Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.

Group IV: Arm D: 0.5 mg Ranibizumab Q4WActive Control1 Intervention

Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vamikibart

2021

Completed Phase 2

~590

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF agents and corticosteroids, both administered intravitreally. Anti-VEGF agents inhibit vascular endothelial growth factor, reducing abnormal blood vessel growth and leakage in the retina, thereby decreasing macular edema. Corticosteroids reduce inflammation and vascular permeability, which also helps in reducing edema. These treatments are crucial for DME patients as they directly target the underlying causes of macular edema, potentially improving vision and quality of life.