IONIS-FB-LRx for Age-Related Macular Degeneration

Recruiting at 117 trial locations

Overseen By Ionis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ionis Pharmaceuticals, Inc.

Must not be taking: Steroids

Disqualifiers: Diabetic retinopathy, Diabetic macular edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 45 weeks

332 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on chronic steroid treatment. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

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.

Inclusion Criteria

My eyes can be clearly imaged for the study.

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

Best-corrected visual acuity (BCVA) letter score of 35 letters (approx. 20/200 Snellen equivalent) or better on the ETDRS chart

Exclusion Criteria

You have previously been treated with an experimental medication, biological product, or medical device.

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

I have had diabetic eye problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IONIS-FB-LRx or placebo subcutaneously every 4 weeks, completing the treatment period at Week 45

45 weeks

11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• IONIS-FB-LRx

Trial Overview 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.

Participant Groups

Group I: Placebo Experimental Treatment 1 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-LRx Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Ionis Pharmaceuticals, Inc.

Lead Sponsor

Trials

151

Recruited

27,800+

Dr. Brett P. Monia

Ionis Pharmaceuticals, Inc.

Chief Executive Officer since 2020

PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD