What side effects are associated with this type of intervention?

Common side effects of intravitreal corticosteroid treatments for Retinal Vein Occlusion (RVO), such as the IBE-814 IVT Dexamethasone Implant, include increased intraocular pressure, which can lead to glaucoma, and cataract formation. Other potential side effects are eye pain, floaters, and risk of infection or hemorrhage at the injection site. These treatments aim to reduce inflammation and edema but require careful monitoring to manage these adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for Retinal Vein Occlusion (RVO) that are similar to the IBE-814 IVT Dexamethasone Implant include other corticosteroid implants such as the Ozurdex (dexamethasone intravitreal implant). Ozurdex is used to treat macular edema following RVO by reducing inflammation and swelling. Additionally, anti-VEGF (vascular endothelial growth factor) therapies like ranibizumab (Lucentis) and aflibercept (Eylea) are also approved for the treatment of macular edema secondary to RVO. These treatments help to reduce fluid leakage and improve vision by inhibiting the growth of abnormal blood vessels.

What other types of research exist?

Promising novel alternatives to the IBE-814 IVT Dexamethasone Implant for RVO patients include anti-VEGF (vascular endothelial growth factor) therapies such as brolucizumab and faricimab. These agents have shown efficacy in reducing macular edema and improving visual acuity in RVO patients. Additionally, sustained-release corticosteroid implants like the fluocinolone acetonide implant (Iluvien) offer another option for long-term management of inflammation and edema in RVO.

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Corticosteroid

Dexamethasone IVT Implant for Eye Swelling Conditions

Phase 2

Waitlist Available

Led By Jagjit Gilhotra

Research Sponsored by Ripple Therapeutics Pty Ltd

Eligibility Criteria Checklist

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

Must have

A diagnosis of CRVO, BRVO, or HRVO with specific retinal and macular criteria

Age ≥ 45 years at the time of informed consent

Must not have

Systemic steroid treatment within 4 months prior to enrollment or anticipated use during the study

Recent acute cardiac events or acute congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements from baseline to 6 months (24 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a small device that releases a medication called dexamethasone directly into the eye. It targets patients with Diabetic Macular Oedema (DMO) or Retinal Vein Occlusion (RVO) to help reduce inflammation and swelling in the retina, potentially improving vision. Dexamethasone implants, such as Ozurdex®, have been used in various studies to treat macular edema associated with retinal vein occlusion (RVO) and have shown efficacy in reducing inflammation and improving visual acuity.

Who is the study for?

This trial is for adults over 45 with diabetes and specific retinal conditions like CRVO, BRVO, or HRVO. They must have certain visual acuity and retinal thickness, agree to use double-barrier contraception, and be able to consent. Excluded are those allergic to corticosteroids, with recent intensive insulin treatment or uncontrolled blood pressure, very high HbA1c levels (>12%), severe kidney issues, recent serious heart problems, pregnant women or those planning pregnancy within 24 months.

What is being tested?

The trial tests two doses of IBE-814 IVT Dexamethasone Implant (70ug and 140ug) in patients with Diabetic Macular Edema (DMO) and Retinal Vein Occlusion (RVO). It's a phase II study where the safety assessors don't know which dose participants receive but aim to find out which dosage works better for reducing swelling in the retina.

What are the potential side effects?

Potential side effects may include increased eye pressure especially if there's a history of steroid-induced eye pressure elevation. Other common risks associated with intravitreal implants like infection or inflammation inside the eye could also occur.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific type of retinal vein occlusion.

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I am 45 years old or older.

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I have diabetes with specific eye conditions.

Exclusion Criteria

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

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I haven't taken steroids in the last 4 months and don't plan to during the study.

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I have not had a recent heart attack or worsening heart failure.

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I have or might have an eye infection.

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I am allergic to corticosteroids or ingredients in the study treatment.

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My eye pressure once increased to ≥30 mmHg due to steroids.

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My blood pressure is not under control.

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I have chronic kidney failure and need dialysis or have had a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurements from baseline to 6 months (24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurements from baseline to 6 months (24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements from baseline to 6 months (24 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

Adverse Events

Best Corrected Visual Acuity

Central Subfield Thickness

+4 more

Awards & Highlights

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: Low doseExperimental Treatment1 Intervention

One (1) IBE-814 IVT Implant (70 μg Dexamethasone) Route of administration: intravitreal injections

Group II: High doseExperimental Treatment1 Intervention

Two (2) IBE-814 IVT Implant (140 μg Dexamethasone) Route of administration: intravitreal injections

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IBE-814 70ug

2020

Completed Phase 2

~60

IBE-814 140ug

2020

Completed Phase 2

~60

0 / 10Eligibility 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 Retinal Vein Occlusion (RVO) include corticosteroids like the IBE-814 IVT Dexamethasone Implant and anti-VEGF agents. Corticosteroids reduce inflammation and edema by inhibiting inflammatory cytokines, decreasing vascular permeability, and fluid accumulation in the retina. This is vital for RVO patients as it helps prevent vision loss caused by inflammation and swelling. Anti-VEGF agents work by inhibiting the growth of abnormal blood vessels and reducing vascular permeability, which also helps control edema and improve visual outcomes. Both treatments aim to reduce macular edema and prevent further retinal damage, thereby preserving vision.