Sewickley

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 effect of fenofibrate compared with placebo in preventing worsening of diabetic retinopathy (DR) over six years in people with mild to moderately severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at the start. The study also aims to test a model where ophthalmologists collaborate with primary care providers like internists or endocrinologists to safely prescribe and monitor the drug. Additionally, the study will assess how blood sugar variability relates to DR outcomes and will include additional studies to understand functional and structural eye changes in participants. Participants will receive either fenofibrate or placebo daily with food, with the dose (either 160mg or 54mg) chosen based on kidney function measured at screening. The dose may be adjusted during follow-up according to the study protocol. The trial is randomized and includes a comparison between the fenofibrate and placebo groups. During the study, participants will be monitored for worsening of diabetic retinopathy over six years. Eye health will be assessed through specialized grading of fundus photographs and visual acuity tests. Kidney function and blood sugar variability will also be tracked. The main outcome measured is the progression of diabetic retinopathy. Researchers will observe safety and effectiveness while participants remain in the study for the full six-year period.

Researchers are evaluating the effect of intravitreal faricimab injections or fluocinolone acetonide (0.19 mg) intravitreal implants compared with observation on long-term visual acuity in patients treated for choroidal melanoma with iodine-125 plaque brachytherapy. This phase 3 randomized controlled trial aims to compare the long-term vision outcomes among eyes receiving repeated treatments versus those initially observed and treated only if macular edema develops. The study also seeks to understand if these treatments can prevent or change the course of macular edema caused by radiation retinopathy and to document the natural progression of radiation retinopathy using multimodal imaging techniques.

Researchers are evaluating the Inspire Upper Airway Stimulation (UAS) System in pediatric subjects aged 18 to 21 years who have moderate to severe obstructive sleep apnea (OSA). This is a prospective, multi-center, single-arm registry study focusing on the safety and effectiveness of this implantable device. Participants will be followed for a total of 5 years after the implant procedure to monitor long-term outcomes. The study involves implanting the Inspire UAS System in eligible participants who have failed or cannot tolerate positive airway pressure treatments and are not successfully treated by adenotonsillectomy. The device is permanently implanted, and participants will use a patient remote to activate the stimulation. Data collection occurs at baseline (before implant), implant activation (1 month post-implant), 6 months post-implant, and then annually at 1, 2, 3, 4, and 5 years post-implant. Participants will undergo various evaluations including sleep studies (both in-lab and at-home), questionnaires, and clinical visits to assess safety and improvement in apnea-hypopnea index (AHI). The study will track any device- or procedure-related adverse events over the 5-year period. Participants must be willing and able to attend follow-up visits and provide informed consent to take part in the registry.

Researchers are evaluating the safety and effectiveness of SL1002 injectable solution compared to a placebo in treating knee pain caused by mild to moderate osteoarthritis. This Phase III randomized, double-blind, placebo-controlled study focuses on patients aged 40 and older who experience chronic knee pain from osteoarthritis. The study aims to understand how a single dose of SL1002 impacts pain levels while walking over a 12-week period. Participants will receive either a single injection of SL1002 or a placebo (normal saline). The study involves screening to confirm eligibility based on factors such as knee osteoarthritis severity and response to diagnostic nerve block. Treatments are administered once, and participants are monitored for safety and pain relief effects throughout the study. During the 12-week study, participants will have their pain intensity while walking assessed regularly to measure changes from baseline. Researchers will also monitor safety through questionnaires, physical exams, and laboratory tests. The study includes assessments to track adherence and ensure compliance with study requirements, with the total participation time spanning from initial screening through week 12 evaluations.

This research aims to improve understanding of the best timing for surgery in patients with symptomatic epiretinal membrane (ERM), a common condition affecting the macula in the eye. The study compares early vitrectomy surgery to remove the ERM versus delaying surgery until vision worsens, to see which approach leads to better visual outcomes. It also seeks to identify factors that predict outcomes after surgery or progression if surgery is deferred, and evaluates the usefulness of measures for visual distortion and reading speed in these patients. Participants will be randomly assigned to one of two groups: one receiving immediate vitrectomy surgery within one month of randomization to remove the ERM, and the other having deferred vitrectomy surgery only if certain vision loss criteria are met, symptoms worsen, or complications arise. Surgery is the main intervention, and the study will closely monitor participants over time to compare these approaches. Throughout the study, researchers will assess changes in visual acuity, distortion symptoms, and reading speed. Visual acuity letter scores will be measured from baseline up to 36 months to evaluate outcomes. Participants undergo regular eye exams and imaging to monitor the macula and ERM status, and their vision and symptoms are tracked to determine the best management approach. The study aims to provide detailed information on how timing of surgery affects vision and quality of life over three years.