Sewickley

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are studying the effects of intravitreal faricimab injections and fluocinolone acetonide intravitreal implants compared to observation on long-term vision in patients treated for choroidal melanoma with iodine-125 plaque brachytherapy. This phase 3 randomized controlled trial aims to evaluate which approach better preserves visual acuity and how these treatments might prevent or change the progression of macular edema caused by radiation retinopathy. The study also seeks to understand the natural course of radiation retinopathy using advanced imaging techniques. Participants will be assigned to one of three groups repeated faricimab injections, fluocinolone acetonide intravitreal implants, or observation. Those in the faricimab group will receive 6.0 mg doses at the start and every three months. Participants in the fluocinolone acetonide group will receive a 0.19 mg implant at the start and again at 24 months. The observation group will be monitored and treated only if macular edema develops. The study uses imaging methods like widefield color photos, fluorescein angiography, and OCTA to monitor eye changes. During the trial, participants will have their visual acuity tracked over three years, with researchers measuring changes from baseline and noting any significant vision loss. The study involves regular eye exams and imaging to assess the development or prevention of radiation retinopathy and macular edema. Safety and treatment effects will be closely monitored throughout the study period, which runs until December 2029.

The trial investigates pediatric patients aged 18 to 21 years diagnosed with moderate to severe obstructive sleep apnea OSA. It evaluates the use of the Inspire Upper Airway Stimulation UAS System implant as a treatment option. This prospective, multi-center, single-arm registry study aims to collect data on safety and effectiveness after the device implantation, following participants for up to 5 years post-implant. Participants will receive the Inspire UAS System implant targeted at managing OSA symptoms. The study includes one group of pediatric subjects meeting the approved device indication and eligibility criteria. Data collection occurs at baseline before implantation, at implant activation one month post-implant, then at 6 months, and annually up to 5 years after implant. During the study, participants will attend scheduled visits for sleep studies, questionnaires, and device assessments to monitor safety and treatment effects. Researchers will evaluate device-related adverse events, changes in apnea hypopnea index AHI, oxygen desaturation index ODI, total sleep time with low oxygen saturation T90, and daytime sleepiness using the Epworth Sleepiness Scale ESS. Ongoing follow-up ensures comprehensive safety and effectiveness data over the full 5-year period.

Researchers are studying the safety and effectiveness of SL1002 injectable solution for treating knee pain in adults with mild to moderate osteoarthritis of the knee. This randomized, double-blind, placebo-controlled Phase III trial compares a single dose of SL1002 against a placebo to better understand its impact on knee pain. Participants will receive either a single injection of SL1002 or a placebo normal saline in a randomized order. The study uses a quadruple masking method to keep participants and researchers unaware of treatment assignments. The treatment is given once, and the effects on knee pain are observed over a 12-week period. Throughout the study, participants will be evaluated regularly to measure changes in daily pain intensity while walking. Researchers will monitor safety, compliance, and response to treatment using pain questionnaires and diagnostic nerve blocks. The main outcome is the change in average daily pain from the start of the study to 12 weeks after treatment. The trial is sponsored by Saol Therapeutics Inc and will last from November 2025 to February 2027.

The trial investigates the best timing for vitrectomy surgery to remove symptomatic epiretinal membranes ERM, a common eye condition that can cause visual distortion. It aims to compare outcomes of immediate surgery versus deferred surgery when vision declines, and to identify predictors of visual outcomes and disease progression. The study also evaluates objective measures of metamorphopsia visual distortion and reading speed that have not been previously used in a randomized clinical trial for ERM. Participants are randomly assigned to one of two groups immediate vitrectomy surgery performed within one month of randomization, or deferred surgery where vitrectomy is delayed until certain vision decline criteria or symptoms worsen. Deferred surgery may be triggered by specific decreases in visual acuity or participant request. The study follows participants for 36 months to assess changes in visual acuity and other vision-related measures. Throughout the study, participants undergo regular eye examinations including visual acuity assessments and imaging with optical coherence tomography OCT to monitor changes in the epiretinal membrane and macular structure. Researchers measure the mean change in visual acuity letter score from baseline to 36 months as the primary outcome. The study also tracks visual distortion and reading speed to understand their usefulness in evaluating ERM. Safety and progression are closely monitored during the three-year follow-up period.

Researchers are evaluating the safety and pain relief effects of the ReneuRx device compared to corticosteroid injections in adults aged 22 to 80 with moderate to severe chronic lateral hip pain. This study focuses on individuals with Greater Trochanteric Pain Syndrome who have persistent pain despite previous conservative treatments. The trial aims to better understand how these interventions perform in managing ongoing hip pain. Participants are randomly assigned to receive either the ReneuRx device injection around the femoral nerve branches near the hip or a corticosteroid injection consisting of a 40mg Triamcinolone dose mixed with saline. The study uses a parallel design with single masking to compare these two treatments. Treatments are administered once, and participants are followed up for effectiveness and safety over several months. During the study, participants attend multiple visits to complete quality of life questionnaires and pain assessments at baseline and various time points up to 12 months post-treatment. Researchers will monitor both the effectiveness of pain relief and any safety concerns throughout the study period. Total follow-up spans approximately 6 to 12 months after treatment to gather comprehensive data on outcomes and participant experience.