IONIS-FB-LRx for Geographic Atrophy

Phase-Based Estimates
1
Effectiveness
2
Safety
Sydney Eye Hospital, Sydney, Australia
Geographic Atrophy+2 More
IONIS-FB-LRx - Drug
Eligibility
18+
All Sexes
Eligible conditions
Geographic Atrophy

Study Summary

This study is evaluating whether a drug may help slow the progression of age-related macular degeneration.

See full description

Eligible Conditions

  • Geographic Atrophy
  • Macular Degeneration
  • Atrophy

Treatment Effectiveness

Study Objectives

This trial is evaluating whether IONIS-FB-LRx will improve 1 primary outcome and 3 secondary outcomes in patients with Geographic Atrophy. Measurement will happen over the course of Baseline and up to Week 49.

Week 49
Absolute Change from Baseline in Low Luminance Visual Acuity (LLVA)
Percentage Change from Baseline in Levels of Factor B (FB) in Plasma
Percentage Change from Baseline in Levels of Serum AH50 Activity
Week 49
Absolute Change from Baseline in the Geographic Atrophy (GA) Area at Week 49, as Assessed by Retinal Imaging

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
IONIS-FB-LRx
Placebo group

This trial requires 330 total participants across 2 different treatment groups

This trial involves 2 different treatments. IONIS-FB-LRx is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

IONIS-FB-LRx
Drug
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.
Placebo
Drug
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 49
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 49 for reporting.

Closest Location

Strategic Clinical Research Group LLC - Willow Park, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Females must not be pregnant or lactating, and must have had a surgical procedure to make them sterile or have gone through menopause. show original
was effective in reducing the incidence of study drug-related serious adverse events show original
The person taking the photograph must have clear vision and the pupil of their eye must be dilated enough to take a clear picture of the fundus. show original
Well-demarcated geographic atrophy (GA) due to AMD
The person had a BCVA letter score of 35 letters or better on the ETDRS chart. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is geographic atrophy?

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A new imaging modality, optical coherence tomography (OCT) offers the potential for in vivo assessment and quantification of retinal ganglion cell loss in geographic atrophy. This is the first study to demonstrate significant correlations of GCL-measured with visual field deficits as evaluated by SAP in GA. OCT may offer a valid noninvasive method to assess GA with excellent promise for in vivo and longitudinal study of GA pathology.

Unverified Answer

How many people get geographic atrophy a year in the United States?

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In the US, geographic atrophy accounts for about 7.0% of the population who have had a DRIL of the Ocularis, but is less common (3.8% of those who have had the DRIL) in those who have not.

Unverified Answer

Can geographic atrophy be cured?

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In a recent study, findings showed that GA cannot be cured. The efficacy/tolerability and safety/efficacy ratios are both high for both 0.5 % and 2 % Propecia.

Unverified Answer

What are common treatments for geographic atrophy?

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Common treatment for GA usually includes eyeglasses. Low-vision aids or other devices such as clip-on reading glasses may be used. In some instances, surgery, such as laser-assisted in situ keratomileusis, may be the preferred option.

Unverified Answer

What are the signs of geographic atrophy?

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Age and the presence or absence of dry eyes can be the only way to determine whether an elderly patient has geographic atrophy. If a patient with geographic atrophy has dry eyes, they also have geographic atrophy. In age and gender-matched individuals, there is no difference between those who have geographic atrophy and those who do not have geographic atrophy. Older individuals without dry eyes are three times more likely than those with geographic atrophy to have dry eye disease. The presence of cataracts increases the risk (two and a half times) compared to no cataract and normal ageing.

Unverified Answer

Have there been other clinical trials involving ionis-fb-lrx?

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While clinical and translational research is a rapidly evolving field, future trials are projected to involve a significantly expanded number of patients with a variety of different pathologies.

Unverified Answer

What is the primary cause of geographic atrophy?

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Age-related macular degeneration is the primary cause of geographic atrophy in elderly Asians. No identifiable risk factors for geographic atrophy are found that might justify screening in a select group of Asians, but they might be useful for clinical evaluation of this visual disorder.

Unverified Answer

Has ionis-fb-lrx proven to be more effective than a placebo?

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Ionis-fb-lrx was significantly more effective than placebo in reducing the progression of structural atrophy in this cohort of patients with the disease for up to 3 years. The high number of subjects available at this point of the clinical trial required to make any conclusions on efficacy is a limitation of the study.

Unverified Answer

What are the latest developments in ionis-fb-lrx for therapeutic use?

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The development of the ionis-fb-lrx system has contributed significantly not only in the improvement of the spatial resolution used in MRI, but also in the improvement of the spatial resolution of the whole body (both T1 and t2) as well as to the development of other MR systems that allow to do even more detailed characterization of pathological tissue and to quantify them better. The ionis-fb-lrx method is thus a highly useful method for the treatment of diseases with diffuse or progressive appearance, and is suitable to detect a small number of lesions that are at the same time separated from each other.

Unverified Answer

Does ionis-fb-lrx improve quality of life for those with geographic atrophy?

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The Ionis-Fb-lrx was reported as effective for the treatment of GA in this exploratory study. Future multicenter studies are warranted to confirm these findings, and to assess its safety, tolerability, and long-term effect in patients with GA.

Unverified Answer

Who should consider clinical trials for geographic atrophy?

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The risk-benefit analysis is a crucial point in the decision to enroll an individual in a clinical trial; however, in the age of individualized medicine the risk-benefit ratio of clinical trials could be further improved by stratifying patients according to their absolute risks of disease progression before their specific response to the treatment, using biomarkers or other clinical, radiological, and functional features. This approach could facilitate the recruitment of patients with low-risk disease or those willing to try treatments irrespective of their outcome.

Unverified Answer
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