Campbell

Researchers are investigating the effects of APL-3007 combined with SyfovrePegcetacoplan APL-2 in patients with geographic atrophy caused by age-related macular degeneration AMD. This Phase 2 randomized, placebo-controlled study aims to assess the efficacy, safety, tolerability, and pharmacodynamics of these treatments in this eye condition. The study involves multiple centers and uses a masked design to ensure unbiased results. Participants will be assigned to one of three groups two receiving different doses or frequencies of APL-3007 in combination with pegcetacoplan APL-2, and one receiving a placebo along with pegcetacoplan APL-2. The study will evaluate the treatments given as multidose regimens. The treatments focus on complement C3 inhibition to potentially impact disease progression. Throughout the study, participants will undergo assessments including artificial intelligence-based imaging to measure retinal pigment epithelium lesion area and photoreceptor degeneration, safety evaluations through adverse event reporting and visual acuity tests, and blood tests to assess serum markers. These evaluations occur over 12 months to monitor changes from baseline. Participants involvement includes regular visits for these assessments, with the study tracking treatment effects and safety over the duration.

Researchers are evaluating a gene therapy called Ixoberogene Soroparvovec Ixo-vec for people with neovascular wet age-related macular degeneration nAMD, a condition that causes abnormal blood vessel growth in the retina and can lead to vision loss, especially in adults over 65. This Phase 3, randomized, double-masked study compares the effects of a single injection of Ixo-vec to the standard treatment aflibercept. The study aims to assess whether Ixo-vec is not less effective than aflibercept in improving vision, measured by changes in best corrected visual acuity BCVA at one year. Participants are assigned to one of two groups one receives three monthly aflibercept injections followed by a single Ixo-vec injection and sham injections every eight weeks the other group receives three monthly aflibercept injections, a sham injection at week one, and aflibercept every eight weeks. Treatments are delivered through intravitreal injections directly into the eye. Safety, tolerability, and vision outcomes will be closely monitored throughout the study period. During the study, participants will undergo regular eye exams to measure visual acuity and retinal health using various imaging techniques and questionnaires assessing vision-related quality of life. Researchers will track the number of aflibercept injections needed, changes in retinal thickness, and the presence of fluid in the retina. The study lasts at least 56 weeks, with key vision measurements taken at weeks 52 and 56. Safety assessments for ocular and non-ocular adverse events will also be conducted. Participants must be at least 50 years old and have active nAMD in the study eye to join.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are conducting a global, prospective, multi-center observational study to gather real-world data on the long-term effectiveness, economic value, and technical performance of Boston Scientifics commercially approved neurostimulation systems for pain management. The study focuses on patients using these neurostimulation devices according to their approved instructions for use in routine clinical practice. Participants will first undergo a neurostimulation trial period using any commercially approved Boston Scientific neurostimulator for pain. Those who experience a positive outcome from this trial may then receive a permanent implant of the neurostimulation system. Treatment customization will be guided by the investigators judgment and routine care practices at each site. During the study, participants will be observed to collect information on clinical outcomes, technical device performance, and economic factors related to neurostimulation therapy. The research team will monitor participants over the long term to assess how well the therapy manages pain and its associated benefits. The study is expected to continue until May 2035, with ongoing follow-up and data collection throughout this period.

Researchers are evaluating the safety and effectiveness of a single intravitreal injection of 4D-150 in adults aged 50 and older with macular neovascularization caused by neovascular age-related macular degeneration nAMD. This Phase 3 trial compares 4D-150 to an active control treatment, aflibercept, to better understand how these treatments affect vision and eye health in this condition. Participants are randomly assigned to receive either one dose of 4D-150 or aflibercept injections at scheduled visits. The 4D-150 is given as a single intravitreal injection on Day 1, while aflibercept is administered during follow-up visits as needed. The study includes a 52-week period to assess visual changes and a longer 104-week period to monitor the need for additional aflibercept injections and other eye health measures. During the study, participants will undergo eye exams including measurements of visual acuity using the ETDRS letter score and evaluations of the central subfield thickness in the retina. Researchers will track the number and timing of aflibercept injections and monitor any anatomical or functional changes in the treated eye. Safety and stability of vision will be observed throughout the trial period, which lasts up to two years.

Neovascular age-related macular degeneration nAMD, also called wet AMD, involves abnormal growth of new blood vessels in the retina, the light-sensitive tissue at the back of the eye. This study aims to evaluate the safety and effectiveness of Surabgene Lomparvovec ABBV-RGX-314, an investigational gene therapy, in adults aged 50 and older with previously treated nAMD. Approximately 561 participants will be enrolled worldwide to compare this gene therapy with standard treatment. Participants will be randomly assigned to one of three groups. Two groups will receive a single subretinal injection of Surabgene Lomparvovec at different doses, and the third group will receive Ranibizumab injections as needed through an intravitreal route. The study includes an assessment period starting two weeks before treatment and continues for up to five years. Participants will attend monthly visits at hospitals or clinics for treatment and evaluation. During the study, participants will undergo medical assessments, blood tests, side effect monitoring, and complete questionnaires to track treatment effects and safety. The primary outcomes include the rate of intravitreal anti-VEGF injections up to week 54 and adverse events observed up to five years. Secondary outcomes focus on changes in visual acuity and injection rates over three years. This long-term follow-up will help understand the treatment impact and preservation of vision.