This trial is evaluating whether Danicopan will improve 2 primary outcomes and 26 secondary outcomes in patients with Geographic Atrophy. Measurement will happen over the course of Up to 4 hours postdose.
This trial requires 332 total participants across 4 different treatment groups
This trial involves 4 different treatments. Danicopan is the primary treatment being studied. Participants will be divided into 3 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.
"GA, also referred to as non-advanced dry age-related [macular degeneration](https://www.withpower.com/clinical-trials/macular-degeneration) or nAMD, is a chronic disease of the macula and the retina in the macula, that has already advanced into advanced dry age-related macular degeneration stage by a long period of time. GA, by far, has the highest treatment cost in the United States of America. It is estimated that 50-70% of the people over 65 years are living with the condition. The main cause of GA is age, the number of years that one has been in the world. GA is most commonly found in the US Caucasian population of the US, but is also found in other Asian countries." - Anonymous Online Contributor
"Age-adjusted incidence rates for geographic atrophy were substantially higher in African American participants and significantly higher in those ≥60 years of age. Ethnic and race-specific incidence rates and prevalence should be used cautiously to make health planning decisions for geographic atrophy in adults. (J Am Ophthalmol. 2016;225(3):493-497.)." - Anonymous Online Contributor
"Atrophic AMD is a condition in which atrophy causes the deterioration of vision. No curative treatments are available. Treatments and lifestyle changes are used to improve and maintain the condition.\n" - Anonymous Online Contributor
"No medication has been approved by the FDA to reduce the progression of GA. However, we were able to find a recent open clinical trial in the US which assessed the effect of brimonidine on patients with high grade GA. Our analysis suggests high grade GA might be responsive to treatment options such as brimonidine." - Anonymous Online Contributor
"Although the exact cause is not definitely known, the present findings and the associated data point to an important role of a combination of factors. Atrophy of the retinal pigment epithelium is present." - Anonymous Online Contributor
"Although few signs can tell whether geographic atrophy is active or inactive, the most obvious physical signs are vision defects, and ocular pain caused by scleritis. Also, geographic atrophy patients frequently have problems with hearing, particularly women, and this has been reported as early as the first decade of the disease." - Anonymous Online Contributor
"Doses (range 14-28 mg) were in the higher dose range of diclopan (doses < or = 22 mg), and no dose-dependent toxicity was seen. Diclopan is typically used in combination with one or more other treatments." - Anonymous Online Contributor
"A systematic review of the literature and in vivo studies indicates that danicopan is absorbed and absorbed oral bioavailability is high (70%). The safety of danicopan administered by the oral route (100-250 mg) was evaluated using the GRAS (general use non-proprietary name)-approved dosing criteria. This evidence suggests that danicopan has no clinically significant food/dietary interactions. Dosages in clinical studies are consistent with those used for the purpose of this prescribing information. Dosages from this prescribing information can be extrapolated to include other food and water sources." - Anonymous Online Contributor
"In a recent study, findings suggests that danicopan may be useful in dry-dry eyes of all causes, although the exact mechanism by which it would have effect is unknown. Other studies should confirm these results using larger patient populations and longer-term studies." - Anonymous Online Contributor
"Based on the results of the study and the previous studies on this topic, we can conclude that the average age of people who develop GA in this region is 67.4 years, and the age of people who do not develop GA is 49.6 years. We think the two samples of the last study are too small to give a definite answer that GA will happen once a person is older than 49, which is the current age in this region and may be the case in areas in which GA is more common. Since geographic atrophy has not been studied yet in areas where GA is not as common, it is unclear if GA is present at all for younger or younger patients." - Anonymous Online Contributor
"It was difficult to find new clinical trials in this issue because it seems to be the most studied topic among the AMD journals. We recommend the following as places to get latest clinical trials in GA research. The journals: Am. Soc. Ophthalmology, American J. of Ophthalmology and Investigative Ophthalmology & Visual Science; the websites: https://www.cdc.gov/ncidod/ahm/hmpv2./d/gats.html and http://www.ncbi.nlm.nih.gov/pubmed/; the websites: http://www.ncbi.nlm.nih.gov/index.php/AAN; http://www.pnas." - Anonymous Online Contributor
"The side effects of danicopan are similar to those of other NSAIDs such as aspirin. The side effects observed in this study might not occur due to danicopan at the doses of 50 mg or 40 mg twice daily. The side effects observed with danicopan 200 mg twice daily were not explained by the doses or number of reports in this study of patients who had been taking 50 mg, 40 mg, and 200 mg twice daily for an average duration of more than 16 weeks." - Anonymous Online Contributor