What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include intravitreal injections of anti-VEGF agents (e.g., ranibizumab, aflibercept), photodynamic therapy, and emerging treatments like antisense oligonucleotides targeting complement factors. Known side effects of these treatments can include eye pain, vitreous floaters, increased intraocular pressure, and rare instances of endophthalmitis. For antisense oligonucleotides, potential side effects may include injection site reactions, inflammation, and hypersensitivity reactions. It is important to discuss these risks with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). These treatments work by inhibiting the growth of abnormal blood vessels in the retina. While these are not antisense oligonucleotides, they represent a molecular approach to treating AMD. As of now, there are no FDA-approved antisense oligonucleotide therapies specifically targeting complement factors for AMD, making the IONIS-FB-LRx trial a novel approach in this area.

What other types of research exist?

Promising novel alternatives to IONIS-FB-LRx for AMD patients include gene therapies like RGX-314, which delivers a gene encoding a therapeutic protein to inhibit VEGF, and pharmacological agents such as pegcetacoplan, a complement C3 inhibitor. These treatments are currently in advanced stages of clinical trials and show potential for efficacy in reducing the progression of AMD.

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Antisense Oligonucleotide

IONIS-FB-LRx for Age-Related Macular Degeneration

Phase 2

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.

Well-demarcated geographic atrophy (GA) due to AMD

Must not have

Chronic treatment with steroids, including topically or intravitreally administered

History or presence of diabetic retinopathy or diabetic macular edema (DME)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new medication called IONIS-FB-LRx to see if it can slow down eye damage in people with a specific type of age-related vision loss. The study focuses on patients whose condition typically worsens over time and aims to find better treatment options by reducing harmful activities in the eye.

Who is the study for?

This trial is for adults with Geographic Atrophy due to Age-Related Macular Degeneration. Participants must have a certain level of vision, be non-pregnant, non-lactating, and not recently treated with steroids or other investigational drugs. They should also be vaccinated against specific infections.

What is being tested?

The study tests IONIS-FB-LRx's ability to slow down the expansion of damaged areas in the eye caused by AMD. It compares this new treatment against a placebo using high-quality imaging techniques to measure changes over time.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to IONIS-FB-LRx or placebo administration throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant or breastfeeding, and I cannot have children due to surgery or menopause.

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I have a specific type of vision loss due to AMD.

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My eyes can be clearly imaged for the study.

Exclusion Criteria

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

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I am on long-term steroid treatment, including creams or eye injections.

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I have had diabetic eye problems.

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I have no other diseases that could affect my vision besides AMD.

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Stage 1 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45.

Group II: IONIS-FB-LRxExperimental Treatment1 Intervention

Stage 1 participants will receive IONIS-FB-LRx randomized to 1 of 3 dose levels, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 will expand 2 of the dosing cohorts in a new randomized group of participants based on the Stage 1 interim analysis. Participants will be randomized to 1 of 2 of the expanded cohorts, administered subcutaneously every 4 weeks, completing the treatment period at Week 45.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

IONIS-FB-LRx

2019

Completed Phase 2

~30

0 / 6Eligibility 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 Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) therapies, which inhibit abnormal blood vessel growth and leakage in the retina, and antisense oligonucleotides (ASOs) like IONIS-FB-LRx. ASOs work by binding to the mRNA of specific genes, such as complement factor B, to reduce its production. This is crucial for AMD patients because overactive complement pathways can lead to inflammation and tissue damage in the retina. By targeting these pathways, ASOs help to slow the progression of AMD and preserve vision.

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor

148 Previous Clinical Trials

15,166 Total Patients Enrolled

Media Library

IONIS-FB-LRx (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT03815825 — Phase 2

Age-Related Macular Degeneration Research Study Groups: IONIS-FB-LRx, Placebo

Age-Related Macular Degeneration Clinical Trial 2023: IONIS-FB-LRx Highlights & Side Effects. Trial Name: NCT03815825 — Phase 2

IONIS-FB-LRx (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03815825 — Phase 2

Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT03815825 — Phase 2

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