Cary

Researchers are evaluating a new treatment for adults aged 18 to 65 who have Social Anxiety Disorder triggered by public speaking. This Phase 2 clinical trial in the U.S. aims to study the effects, safety, and tolerability of repeated doses of Fasedienol Nasal Spray given intranasally. The study focuses on how well this treatment relieves acute anxiety symptoms caused by a public speaking challenge in a controlled clinical environment. Those who complete the initial study may also join an open-label extension to assess long-term safety and tolerability when using the nasal spray as needed for up to 12 months. Participants will be assigned to one of three groups receiving nasal spray doses 20 minutes before their public speaking challenge. One group gets two doses of Fasedienol Nasal Spray spaced 10 minutes apart, another group gets one dose of Fasedienol followed by a placebo dose, and the last group receives two placebo doses. The study compares these dosing schedules to see which best relieves anxiety symptoms. In the extension phase, eligible participants can use 3.2 micrograms of Fasedienol Nasal Spray up to six times daily for a year to monitor longer-term effects. During the study, participants will undergo clinical evaluations including anxiety rating scales and distress measurements before and after treatment. Researchers will assess responses to the public speaking challenge and monitor safety through physical exams and laboratory tests. The main outcome measured is the Subjective Units of Distress Scale over seven days between visits. Safety, tolerability, and symptom relief will be closely tracked throughout both the initial and extension phases, which together may last up to 12 months for some participants.

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

Researchers are evaluating the safety, tolerability, and effectiveness of DermaBind TL, a placental membrane allograft, in adult patients with chronic non-healing wounds such as diabetic foot ulcers and venous leg ulcers. This Phase 4, open-label, single-arm clinical trial aims to collect patient outcome data over a 12-week treatment period, comparing results to each participant's historical treatment data. The study focuses on wound area preservation, infection rates, wound recurrence, graft usage, and treatment-emergent adverse events. During the 12-week treatment phase, participants will receive DermaBind TL applied to their affected chronic wounds. The trial involves two phases: screening and treatment. Clinicians will assess wounds regularly, and the intervention will be monitored for its ability to protect wounds, reduce infections, and promote healing. The study includes careful evaluation of wound characteristics and patient response to the graft treatment. Participants will be closely monitored throughout the trial, including wound assessments by clinicians and data collection on infection rates, wound size, and safety events. The primary outcome is to measure how well the wound covering protects the wound over the 13-week treatment period. The study also tracks adverse events and other clinical outcomes through the end of the study. Overall participation includes screening and a 12-week treatment period, with detailed follow-up to evaluate the intervention's effects.

Researchers are conducting a Phase 3 study to evaluate the safety and effectiveness of an intravitreal injection called KSI-101 in adults with macular edema caused by inflammation, known as MESI. This condition involves swelling in the central part of the retina and can affect vision. The study aims to compare KSI-101 to sham injections to understand its impact on improving vision. Participants will receive either KSI-101 or sham injections directly into the eye. The treatment is given through intravitreal injections, which deliver medication inside the eye. The study is randomized, double-masked, and sham-controlled, meaning neither participants nor doctors know who receives the active drug or sham injections. This design helps provide clear and unbiased results. Throughout the study, participants will have their vision assessed, including measuring changes in best-corrected visual acuity (BCVA) at 24 weeks. Researchers will monitor the thickness of the central retina area and check for safety and side effects. Participants will be followed regularly to track vision changes and eye health during the study period.

Researchers are conducting a Phase 3 clinical trial to evaluate the effectiveness and safety of an investigational drug called KSI-101 for people with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation (MESI). The study focuses on participants who have specific retinal thickness and vision measurements and includes those with active or inactive non-infectious inflammation in one eye. The trial aims to understand how well KSI-101 works compared to a sham injection in improving vision. Participants will receive either KSI-101 through an injection into the eye (intravitreal injection) or a sham injection as a comparison. The study is double-masked and randomized, meaning neither the participants nor the researchers know which treatment is given. The treatment schedule and detailed dosing are not specified here, but the trial includes careful monitoring of participants over time. During the study, participants' vision will be assessed, specifically measuring the change in best-corrected visual acuity (BCVA) after 24 weeks. Other assessments include measuring retinal thickness with imaging technology. Researchers will monitor safety and any side effects throughout the trial. Participation involves regular visits for these evaluations, and the study is designed to gather detailed information on how the treatment affects vision and eye health over the study period.

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.