Parramatta

Researchers are evaluating the safety and preliminary effectiveness of THN391, a drug given as monotherapy, in adults with diabetic macular edema (DME) caused by non-proliferative diabetic retinopathy. This Phase 1b open-label study focuses on how well participants tolerate THN391 and its biological activity in the eye, aiming to gather early data on the drug's impact on this eye condition. The study involves an open-label, multiple ascending dose design where approximately 21 participants are enrolled into three sequential groups receiving increasing doses of THN391. Participants will receive three monthly injections of THN391 directly into the eye (intravitreal injection). The dose escalation is carefully monitored to assess safety at each level. Participants will be followed for up to 16 weeks after their first dose to monitor for any adverse events. Throughout the study, researchers will assess the safety and tolerability of the treatment, as well as its biological effects. The total participation involves multiple visits for dosing and safety assessments to ensure thorough monitoring of each participant's response to the treatment.

Researchers are evaluating the safety, effectiveness, and how the body processes VX-01 as an oral treatment for people with moderate to severe Non-Proliferative Diabetic Retinopathy (NPDR) without clinically significant diabetic macular edema (CI-DME). This Phase 2, multi-center study compares VX-01 to a placebo over 52 weeks, aiming to see if daily doses can improve the condition in adults with Type 1 or Type 2 diabetes. Participants will be randomly assigned to receive either VX-01 tablets (150 mg twice daily) or matching placebo tablets twice daily for one year. The study groups are balanced based on the presence of proliferative diabetic retinopathy and blood sugar control levels. After the 52-week treatment period, there is a 12-week follow-up phase where all participants continue to be monitored without the study drug. During the study, participants will have regular eye exams, including imaging and visual acuity tests, and blood tests to monitor safety and treatment effects. Researchers will track adherence to medication and evaluate outcomes such as vision changes and diabetic retinopathy progression. Safety and tolerability will also be closely observed throughout the treatment and follow-up periods, with total participation lasting about 64 weeks.

Researchers are studying the safety and how well different doses of FWY003 work in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This Phase 2 study aims to understand the relationship between the dose of FWY003 and its effects compared to a placebo. The study is randomized, multi-center, and double-masked, ensuring that neither participants nor researchers know who receives the drug or placebo. Participants will be assigned to receive either FWY003 at specific doses or a placebo. The study is designed to find the best dose by comparing the effects of FWY003 against placebo in patients with GA secondary to AMD. Treatments will be given according to the study protocol, and the response to different doses will be monitored to assess both efficacy and safety. During the study, participants will be evaluated for changes in the size of their GA lesions from the start of the study to month 18. Eye examinations and imaging will be used to monitor the lesion area and vision status. Safety will be closely observed throughout the study, with regular check-ups and assessments to monitor any side effects or changes in eye health.

Researchers are working on the ETHOS II Project to improve care for people with hepatitis C virus (HCV) in drug treatment clinics and needle and syringe programs (NSPs) across New South Wales and Australia. The project aims to create a framework for better HCV screening and treatment services in these settings nationally. It is a collaborative effort involving multiple health and research organizations, focusing on individuals with a history of injecting drug use or those receiving opioid substitution therapy. The study involves an intervention that includes on-site HCV RNA testing, liver fibrosis assessment, and helping participants connect to care to increase the use of direct-acting antiviral therapy for HCV. Participants will undergo procedures such as Hepatitis C testing, fibroscan, questionnaires, and clinical assessments during "campaign days." A sub-study will invite 550 participants to provide blood samples to evaluate new diagnostic tests for chronic HCV infection. The project also includes interviews with policy makers, clinicians, and patients to understand challenges in HCV care, and the development of an education and training program to improve workforce skills and HCV care quality. Participants will be recruited from drug treatment clinics, general practices, and NSP programs. They will complete surveys and may consent to link their data with health databases for ongoing study. The main outcome measured is the number of participants starting anti-HCV treatment each year for up to three years. Researchers will monitor participant health records and follow up through medical record reviews, ensuring thorough tracking of treatment initiation and care engagement throughout the study duration.

Researchers are evaluating the effects of ADX-038, a siRNA duplex oligonucleotide, in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This Phase 2 study compares ADX-038 with a placebo to assess its ability to preserve the ellipsoid zone (EZ) layer in the eye over 12 months. The study also monitors safety, pharmacokinetics, and pharmacodynamics. Participants will receive subcutaneous injections of either ADX-038 or a saline placebo. The study is randomized, masked, and placebo-controlled, ensuring unbiased comparison between the two groups. The treatment period lasts for 12 months, during which participants will undergo regular clinic visits and follow study procedures. During the study, participants will have eye examinations and imaging to evaluate the condition of the GA lesions and the EZ layer. Researchers will track adherence to study visits and vaccinations required by the protocol. The main goal is to measure the effect of ADX-038 on preserving the EZ layer at 12 months, while monitoring safety and any adverse effects throughout the study.