Johnson City

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

This research aims to evaluate how well and safely elafibranor works compared to a placebo in adults with Primary Sclerosing Cholangitis PSC, a rare liver disease that causes inflammation and scarring of bile ducts. PSC can lead to serious liver damage, including the need for liver transplant or death. The study is a Phase III trial involving about 350 adults with large duct PSC, conducted to understand treatment effects over an extended period. Participants will be randomly assigned to take either 120 mg of elafibranor or a placebo tablet once daily. The study includes a screening period, a treatment phase expected to last about five years until enough health events occur, and a post-treatment safety follow-up approximately four weeks after treatment ends. The study is double-blinded and placebo-controlled, ensuring unbiased evaluation of elafibranors effects. During the study, participants will undergo regular clinical assessments, laboratory tests, imaging, and patient-reported evaluations to monitor liver disease progression, symptoms like fatigue and itching, quality of life, and safety. The primary outcome measured is event-free survival from baseline up to five years. Participants may withdraw at any time, and the total duration for each participant may span several years including treatment and follow-up.

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are assessing three different methods to prevent peripheral neuropathy caused by taxane chemotherapy drugs like paclitaxel or docetaxel. This phase III trial compares cryocompression, continuous compression, and low cyclic compression therapies using the Paxman Limb Cryocompression System, which applies cooling andor pressure to the arms and legs. The study aims to see if any of these approaches can reduce the nerve damage that leads to numbness, tingling, or pain during chemotherapy. Participants are randomly assigned to one of three groups cryocompression therapy cooling plus moderate and low pressure, continuous compression therapy steady moderate pressure, or low cyclic compression therapy low pressure that cycles on and off. Each therapy is applied for 30 minutes before, during, and after each taxane chemotherapy infusion. Blood, serum, and plasma samples may be collected during screening and throughout the study. During the study, participants will complete questionnaires and undergo evaluations of nerve function and physical tests at multiple time points up to 52 weeks. Researchers will monitor side effects related to the devices, participant satisfaction, and chemotherapy dosing impacts. The main outcome measured is the occurrence of clinically meaningful chemotherapy-induced peripheral neuropathy at 12 weeks after starting treatment, with additional assessments over time to understand the therapies effects and tolerability.

This clinical trial studies the effects of a new treatment called corneal crosslinking CXL for eye conditions where the cornea becomes thin, steep, and misshapen, causing blurry vision. The trial focuses on patients aged 8 years and older diagnosed with keratoconus, ectasia after LASIK or PRK, pellucid marginal degeneration, progressive ectasia after previous CXL, or forme fruste keratoconus. The main goal is to find out if CXL can slow or stop the progression of these corneal diseases and prevent vision loss. Participants will receive CXL treatment where riboflavin Vitamin B2 eye drops is applied to the eye, followed by exposure to ultraviolet A UVA light. Two groups will be compared one group receives UVA treatment for 18 minutes and the other for 24 minutes, both with 15-second off-on cycling. The treatment aims to strengthen the cornea and stop disease progression. During the 6-month study, participants will attend up to 7 office visits for eye and vision tests. Researchers will measure corneal curvature using Kmax with the Pentacam and corrected distance visual acuity CDVA to evaluate effectiveness. Secondary measures include uncorrected visual acuity UCVA and possibly changes in higher order aberrations HOA and coma if wavefront testing is done. Safety and treatment effects will be monitored throughout the study period.

Researchers are studying an experimental treatment called corneal crosslinking CXL for people with Down syndrome who have corneal conditions where the cornea thins, steepens, and becomes misshapen, causing blurred vision. This treatment aims to strengthen the cornea and possibly prevent or slow vision loss. The study focuses on whether CXL can stop or slow this progression. Participants must be at least 8 years old and diagnosed with Down syndrome or similar cognitive or developmental conditions. The treatment involves applying riboflavin Vitamin B2 eye drops to the eye, followed by exposure to ultraviolet A UVA light for 20 minutes. This process is called Epi-ON corneal cross-linking and is performed during the study. Participants will receive this treatment and be monitored over a 6-month period. Participants will attend up to 7 in-office visits during the 6 months, where various eye and vision tests will be conducted. Researchers will measure corneal curvature and vision changes using tools like the Pentacam and visual acuity tests. They will also assess vision improvements with additional measures such as high order aberrations and coma. The study includes follow-up visits to track treatment effects and safety over time.

This research aims to compare changes in walking abilities in people with Parkinson disease after completing an 8-week independent walking program either with or without walking poles. Participants will be assessed on various walking, movement, and cognitive measures before starting the program to establish baseline data. The study focuses on understanding how the use of walking poles may affect walking performance and cognitive function in this population. Participants will be randomly assigned to one of two groups those who will use walking poles during their walking exercises and those who will not. Before beginning the program, participants receive training on how to properly use walking poles and practice walking with them. The walking program requires participants to walk independently at least three times per week for eight weeks while keeping a log of their walking sessions, including duration, perceived exertion, and any adverse events. Follow-up training and assessments include walking tests with and without poles to monitor progress. Throughout the study, participants will undergo several assessments including walking tests like the Six Minute Walk Test, Timed Up and Go, and the Backward Walk Test using advanced motion sensors and heart rate monitors. Cognitive function will be evaluated using tools like the Montreal Cognitive Assessment and Trail Making Test. Self-reported questionnaires will assess balance confidence, disability, and freezing of gait. After the 8-week program, participants will be reassessed, and again at a 3-month follow-up to evaluate sustained effects. Regular contact with study members ensures monitoring of adherence and any adverse events during the program.