What is the mechanism of action of this treatment?

The most common treatments for Diabetic Macular Edema (DME) include anti-angiogenic agents like vascular endothelial growth factor (VEGF) inhibitors and anti-inflammatory agents such as corticosteroids. VEGF inhibitors, such as ranibizumab and aflibercept, work by blocking the action of VEGF, a protein that promotes the growth of abnormal blood vessels and increases vascular permeability, leading to fluid leakage and swelling in the retina. By inhibiting VEGF, these treatments reduce fluid accumulation and improve vision. Corticosteroids, on the other hand, reduce inflammation and edema by suppressing the immune response and decreasing the permeability of blood vessels. These mechanisms are crucial for DME patients as they directly address the underlying causes of macular swelling and vision impairment, thereby improving visual outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Diabetic Macular Edema (DME) include intravitreal injections of anti-VEGF agents (such as ranibizumab and aflibercept) and corticosteroids (such as dexamethasone implants). The side effects of anti-VEGF agents can include eye pain, vitreous floaters, increased intraocular pressure, and rare cases of endophthalmitis. Corticosteroid injections may lead to increased intraocular pressure, cataract formation, and potential risk of infection. Both treatment types require careful monitoring by an ophthalmologist to manage these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Macular Edema (DME), primarily focusing on anti-angiogenic agents. Notable among these are anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). These drugs work by inhibiting the growth of abnormal blood vessels and reducing fluid leakage in the eye. Additionally, corticosteroids like dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide implant (Iluvien) have been approved for their anti-inflammatory properties, helping to reduce swelling and improve vision in patients with DME.

What other types of research exist?

Promising novel alternatives to AG-73305 for Diabetic Macular Edema (DME) patients include anti-VEGF therapies such as faricimab, which targets both VEGF and Ang-2 (angiopoietin-2), and novel corticosteroid implants like the fluocinolone acetonide implant. Additionally, investigational drugs like KSI-301, a bioconjugate therapy, and RGX-314, a gene therapy, are showing potential in clinical trials.

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AG-73305 for Diabetic Macular Edema

Phase 2

Waitlist Available

Research Sponsored by Allgenesis Biotherapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Presence of center-involving DME in the study eye with CST ≥ 325 μm

Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association

Must not have

Uncontrolled diabetes mellitus, defined as hemoglobin A1c > 12.0% at Screening

Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AG-73305, which is injected directly into the eye. It aims to help patients with diabetic macular edema, a condition where fluid builds up in the eye due to diabetes. The drug works by reducing this fluid buildup, potentially improving vision.

Who is the study for?

This trial is for adults over 18 with diabetic macular edema (DME) affecting the center of the retina and vision loss due to DME. Participants must have a certain level of central retinal thickness and visual acuity. Excluded are those with recent treatments like Ozurdex or Iluvien, uncontrolled diabetes or high blood pressure, chronic kidney disease, eye infections, high eye pressure, or recent anti-VEGF treatment.

What is being tested?

The study tests different doses of AG-73305 given as an injection inside the eye to people with DME. It's an open-label trial where everyone knows what treatment they're getting. The goal is to find out how safe it is and how well it works at various dose levels.

What are the potential side effects?

While specific side effects for AG-73305 aren't listed here, similar treatments may cause eye irritation or redness, increased intraocular pressure, bleeding in the eyes, cataract formation, and potential risk of infection from injections.

Eligibility Criteria

Inclusion Criteria

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

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My eye condition involves swelling in the center with a thickness of 325 μm or more.

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

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My vision loss due to DME falls within the specified range for the study.

Exclusion Criteria

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

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My diabetes is not under control, with an A1c level over 12%.

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My blood pressure is not controlled and is very high.

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I currently have an infection in one or both of my eyes.

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I haven't had VEGF treatment in my eye for 6-8 weeks.

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I have long-term kidney disease.

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My eye pressure is high (>25 mmHg) despite using glaucoma medications, or I need more than 2 medications to control it.

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

Group I: Cohort 4Experimental Treatment1 Intervention

A single IVT dose of 4 mg AG-73305

Group II: Cohort 3Experimental Treatment1 Intervention

A single IVT dose of 2 mg AG-73305

Group III: Cohort 2Experimental Treatment1 Intervention

A single IVT dose of 1 mg AG-73305

Group IV: Cohort 1Experimental Treatment1 Intervention

A single intravitreal (IVT) dose of 0.5 mg AG-73305

0 / 9Eligibility 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-angiogenic agents like vascular endothelial growth factor (VEGF) inhibitors and anti-inflammatory agents such as corticosteroids. VEGF inhibitors, such as ranibizumab and aflibercept, work by blocking the action of VEGF, a protein that promotes the growth of abnormal blood vessels and increases vascular permeability, leading to fluid leakage and swelling in the retina. By inhibiting VEGF, these treatments reduce fluid accumulation and improve vision. Corticosteroids, on the other hand, reduce inflammation and edema by suppressing the immune response and decreasing the permeability of blood vessels. These mechanisms are crucial for DME patients as they directly address the underlying causes of macular swelling and vision impairment, thereby improving visual outcomes and quality of life.