Bloomfield

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

This research investigates intravitreal EYE103 in adults with neovascular age-related macular degeneration NVAMD or macular edema caused by branch retinal vein occlusion BRVO. The trial is randomized and dose-masked, including four different patient groups to study different doses and combinations of EYE103, aiming to assess its effects in these eye conditions. Participants are divided into four cohorts treatment-naive NVAMD, incomplete responders IR with NVAMD as monotherapy, IR NVAMD combined with aflibercept, and treatment-naive BRVO. Each cohort randomly receives either a low or high dose of EYE103 via intravitreal injection. All receive three injections spaced 4 weeks apart the IR NVAMD combination group also receives aflibercept on Day 1. Assessments occur at each injection visit and some groups return 2 weeks post-injection for extra evaluations. During the 12-week study, participants undergo safety and efficacy assessments including vision tests using ETDRS charts, slit-lamp exams, fundoscopy, and imaging with spectral domain optical coherence tomography SD-OCT to measure retinal thickness. The studys main measure is the change in best-corrected visual acuity at Week 12. The trial also monitors retinal thickness and vision changes throughout. The Week 12 visit marks the studys end for all participants.

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.

The trial investigates the corneal endothelial cells in adults aged 50 and older with neovascular age-related macular degeneration nAMD who are treated with the Port Delivery System PDS implant delivering ranibizumab. This Phase IV, open-label study aims to monitor changes in corneal endothelial cell density over time, comparing the treated eye with the fellow eye to evaluate the effects of this device-based treatment approach. Participants will have a PDS implant surgically inserted in the study eye, initially filled with ranibizumab before implantation. Following this, the implant will be refilled every 24 weeks. Supplemental intravitreal ranibizumab injections may be given if the participant stops study treatment, based on investigator discretion. The study monitors participants for at least 48 weeks, focusing on corneal cell changes and ocular safety events. During the study, participants undergo assessments including specular microscopy to measure corneal endothelial cell density and morphology at baseline and at weeks 24 and 48. Researchers will track ocular adverse events, device-related effects, and serious safety concerns throughout the approximately one-year follow-up. The study collects visual acuity data, imaging results, and historical treatment records to support evaluation. Participants remain under close observation to assess treatment impact and safety.

Researchers are evaluating the effectiveness of a visual-acoustic biofeedback treatment delivered via telepractice for children aged 8 to 17 years who have speech sound disorders affecting the production of the s sound. The study aims to determine whether this biofeedback method can improve s sound accuracy compared to no treatment and if it positively influences social-emotional well-being for participants and their guardians. The study involves six children with distortions of the s sound. Participants will first undergo an initial evaluation to confirm eligibility and then be randomly assigned to begin treatment after 4 to 10 baseline sessions where their s sound production is assessed but not treated. All children will receive 20 one-hour biofeedback treatment sessions over 10 weeks, followed by three maintenance sessions. Treatment is provided individually by a certified speech-language pathologist via password-protected Zoom videoconference calls, using software that provides real-time visual feedback and adjusts practice difficulty based on participant performance. Throughout the study, participants will complete standard word probes at baseline and after treatment to measure the accuracy of their s sound production. Surveys will also be conducted before and after treatment to assess changes in social-emotional well-being. The trial includes monitoring of speech production during sessions with software-guided feedback, and participants will practice producing sounds in structured blocks. The total study duration includes baseline, treatment, and maintenance sessions, with outcomes assessed after 20 weeks.

Researchers are conducting a phase 3 randomized, double-masked study to compare the effects of EYP-1901 against Aflibercept in patients with diabetic macular edema DME, a condition related to diabetic retinopathy. The study aims to evaluate the treatments impact on vision improvement, with a focus on the average change in best-corrected visual acuity BCVA over one year. Participants are assigned to receive either EYP-1901 or Aflibercept, both delivered by intravitreal injection directly into the eye. The study uses a parallel group design with random allocation and masking to compare these two drug treatments. The primary measurement is taken at weeks 52 and 56, with secondary outcomes including the rate of injection burden by week 56. During the study, participants will undergo regular vision assessments using the ETDRS letter score. Researchers will monitor treatment effects and safety throughout the trial period, which extends until October 2028. The total participation time includes screening, treatment, and follow-up visits designed to evaluate vision changes and treatment needs over approximately one year.

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 evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab PDS in people with neovascular age-related macular degeneration nAMD. This study includes participants who have completed earlier related studies or met specific criteria in a recent study. Two sub-studies are included one assessing the use of transscleral photocoagulation TPC to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants will receive PDS implants and undergo refill-exchanges of ranibizumab at various intervals, mostly every 24 weeks Q24W, with some switching to every 12 weeks Q12W visits later in the study. The transscleral photocoagulation sub-study involves PDS implantation using TPC followed by ranibizumab refills. The re-implantation sub-study includes follow-up for up to 72 weeks after receiving the updated implant and scheduled refill-exchanges. During the study, participants will attend scheduled visits for treatment and assessments lasting up to several years. Researchers will monitor ocular and systemic adverse events, focusing on the severity and duration of side effects related to the device and treatment. Vision and eye health will be regularly evaluated using tests like best-corrected visual acuity and imaging. Safety data from the sub-studies will also be collected, including rates of vitreous hemorrhage and other ocular events, with study participation extending until regulatory decisions or study closure.

Speech Sound Disorder SSD affects many school-aged children, leading to social and emotional challenges that may continue into adolescence and adulthood. Researchers are studying the effects of an AI-guided home practice program to support speech sound generalization after participants complete a related biofeedback treatment study called VISIT. This study aims to see if using AI tools at home can improve speech sound accuracy in children and adolescents with SSD. Participants in this study will be randomized to receive either treatment as usual TAU or treatment as usual plus an AI-guided maintenance program with biofeedback TAUAI. The AI-guided practice uses a web interface called staRt that provides real-time visual feedback of speech sounds and classifier feedback on the accuracy of the American English r sound. All treatment sessions happen at home, while evaluations before and after the six-week GAINS study occur in the lab. During the study, participants will be assessed on speech sound accuracy by blinded listeners who rate their production of r sounds in word probes before and after the treatment period. Researchers will also collect data on regular community-based care during the study. The study starts with a six-week treatment phase, with continuous monitoring of progress and speech accuracy. Participants must have completed the VISIT study and meet specific language, hearing, and computer access requirements to take part.

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.