What is the mechanism of action of this treatment?

Age-Related Macular Degeneration (AMD) treatments often target abnormal blood vessel growth in the retina, a hallmark of the disease. Tyrosine Kinase Inhibitors (TKIs) like axitinib work by inhibiting pathways that promote the formation of these abnormal vessels, thereby reducing leakage and swelling in the retina. Other common treatments include anti-VEGF (vascular endothelial growth factor) therapies, which directly block VEGF, a protein that stimulates blood vessel growth. By controlling abnormal vessel growth, these treatments help preserve vision and prevent further retinal damage, which is crucial for maintaining quality of life in AMD patients.

What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) that involve tyrosine kinase inhibitors (TKIs) like axitinib, which reduce abnormal blood vessel growth, can have several ocular side effects. These may include dry eyes, conjunctivitis, and uveitis, which are generally mild and manageable with symptomatic treatments such as artificial tears or topical steroids. More severe but less common side effects include macular edema, macular ischemia, and serous retinal detachment, which can lead to significant vision loss and require immediate cessation of the medication and referral to a retina specialist. Overall, while TKIs are effective in managing AMD, they necessitate careful monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD) that target abnormal blood vessel growth, similar to the mechanism of action of the Intravitreal OTX-TKI (Axitinib Implant). 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 in the retina, thereby reducing fluid leakage and vision loss. While these treatments are not TKIs, they share a similar goal of targeting pathways involved in neovascularization.

What other types of research exist?

Promising novel alternatives to Intravitreal OTX-TKI (Axitinib Implant) for Age-Related Macular Degeneration patients include Faricimab, a bispecific antibody targeting both Angiopoietin-2 and VEGF-A, and Brolucizumab, a single-chain antibody fragment targeting VEGF-A. Both have shown efficacy in reducing abnormal blood vessel growth and are being considered for their potential benefits in AMD treatment.

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Anti-VEGF Therapy

Axitinib Implant for Age-Related Macular Degeneration

Phase 3

Recruiting

Led By Dilsher Dhoot, MD

Research Sponsored by Ocular Therapeutix, Inc.

Eligibility Criteria Checklist

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

Must have

Are at least older than 50 years of age at Day 1

Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 104 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a small device placed in the eye that releases medication for patients with a severe form of AMD. The medication helps stop abnormal blood vessel growth in the eye, potentially preventing further vision loss. This approach has significantly improved treatment for this condition in recent years.

Who is the study for?

This trial is for individuals over 50 years old with a new diagnosis of Neovascular Age-Related Macular Degeneration (nAMD) and have not been treated for it. They must have good vision in at least one eye, with a visual acuity score close to 20/20. People can't join if they only have one working eye or very poor vision in their other eye.

What is being tested?

The study tests the effectiveness and safety of an implant called OTX-TKI (axitinib implant), which is placed inside the eye, against Aflibercept, an existing treatment for nAMD. The goal is to see how well these treatments help maintain or improve vision.

What are the potential side effects?

Possible side effects may include discomfort in the eye, increased pressure within the eyeball, bleeding, infection risk after the procedure, and potential inflammation or irritation from either treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am over 50 years old.

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My vision, with correction, is about 20/20.

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I have not received any treatments for wet AMD in either eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best corrected visual acuity (BCVA)

Other study objectives

Incidence and severity of treatment emergent adverse events (AEs)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: OTX-TKI (axitinib implant)Experimental Treatment1 Intervention

Group II: ControlExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept

2016

Completed Phase 4

~2550

0 / 3Eligibility 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

Age-Related Macular Degeneration (AMD) treatments often target abnormal blood vessel growth in the retina, a hallmark of the disease. Tyrosine Kinase Inhibitors (TKIs) like axitinib work by inhibiting pathways that promote the formation of these abnormal vessels, thereby reducing leakage and swelling in the retina. Other common treatments include anti-VEGF (vascular endothelial growth factor) therapies, which directly block VEGF, a protein that stimulates blood vessel growth. By controlling abnormal vessel growth, these treatments help preserve vision and prevent further retinal damage, which is crucial for maintaining quality of life in AMD patients.

Evaluation of Long-Lasting Potential of Suprachoroidal Axitinib Suspension Via Ocular and Systemic Disposition in Rabbits.Axitinib modulates hypoxia-induced blood-retina barrier permeability and expression of growth factors.