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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.