Campbell

Researchers are evaluating the safety and effectiveness of Ixoberogene Soroparvovec (Ixo-vec) for treating neovascular (wet) age-related macular degeneration (nAMD) in adults aged 50 years and older. This Phase 3, multi-center, randomized, double-masked study compares a single intravitreal injection of Ixo-vec with an active comparator, Aflibercept. The study focuses on a broad population including both treatment-naïve and treatment-experienced participants, aiming to assess if Ixo-vec is not less effective than the comparator in improving vision. Participants will receive one intravitreal injection of either Ixo-vec or Aflibercept. Ixo-vec is a gene therapy designed to reduce the treatment burden by potentially decreasing the need for frequent injections that are common in current anti-VEGF treatments for nAMD. The study includes a screening period followed by treatment administration and ongoing safety and efficacy assessments. During the study, participants will undergo regular evaluations including measurements of best corrected visual acuity (BCVA) at baseline and at Weeks 52 and 56 to monitor changes in vision. Safety, tolerability, and treatment response will be closely observed throughout the study duration. Researchers will also monitor anatomical responses to therapy and overall eye health through clinical assessments and adherence to eye drop use as required by the protocol.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.

Researchers are evaluating a treatment for adults aged 50 and older who have macular neovascularization caused by neovascular age-related macular degeneration (nAMD). This Phase 3 trial compares a single intravitreal injection of 4D-150 with the active control treatment EYLEA (aflibercept). The study aims to assess changes in visual acuity over one year to better understand the effects of these treatments on this eye condition. Participants are randomly assigned to receive either a single dose of 4D-150 injected into the eye on Day 1 or ongoing EYLEA injections at scheduled visits. The study includes adults who have either never received anti-VEGF therapy or have had up to four prior anti-VEGF injections with documented improvement. The condition must be active and confirmed by specialized eye imaging tests before enrollment. Throughout the 52-week study, participants will have regular assessments including vision tests measured by the ETDRS letter score, eye imaging, and clinical evaluations to monitor treatment effects and safety. Researchers will track visual acuity changes from the start of treatment and watch for any adverse effects. The study's main goal is to measure the average change in best corrected visual acuity at one year.

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 Phase 3b study is evaluating how safe and effective Surabgene Lomparvovec (ABBV-RGX-314), an investigational gene therapy, is in treating adults aged 50 and older who have previously been treated for nAMD. Approximately 561 participants will be enrolled at about 150 sites worldwide to compare different treatment approaches in a real-world setting. Participants will be randomly assigned to one of three groups. Two groups will receive a single subretinal injection of Surabgene Lomparvovec, while the third group will receive Ranibizumab injections as needed. Ranibizumab is given as an intravitreal injection into the jelly-like tissue inside the eye, whereas Surabgene Lomparvovec is injected between the retina and the back of the eye. The assessment period begins two weeks before treatment and continues for up to 5 years, allowing long-term monitoring of treatment effects. Participants will attend monthly visits at a hospital or clinic to monitor their eye health. These visits include medical assessments, blood tests, side effect checks, and questionnaires. Researchers will measure the annualized rate of anti-VEGF injections needed and record any adverse events over the 5-year period. The study involves a higher treatment burden than standard care, but aims to gather detailed information on long-term vision preservation and safety.