Bloomfield

Researchers are investigating new treatments for neovascular age-related macular degeneration (NVAMD), a form of wet macular degeneration. This study aims to find out if a medicine called tiespectus (also known as MK-8748 or EYE201) can treat NVAMD as effectively as the current standard treatment, aflibercept. The trial is a pivotal Phase 2/3 study comparing these treatments in people with this eye condition. Participants will be randomly assigned to one of three groups: one receiving a low dose of tiespectus, another receiving a high dose of tiespectus, and a third group receiving aflibercept. The tiespectus groups start with three injections every four weeks, then continue with injections every eight weeks until week 48. After this, the treatment schedule is personalized up to week 92. The aflibercept group also receives three initial injections followed by injections every eight weeks until week 92. During the study, participants will have their vision assessed using best-corrected visual acuity (BCVA) and other eye measurements at baseline and through one year. Researchers will monitor changes in vision, eye thickness, and any side effects. The entire study period includes treatment and follow-up visits up to approximately 92 weeks, allowing detailed observation of treatment effects and safety over time.

Researchers are studying intravitreal EYE103 in people with neovascular age-related macular degeneration (NVAMD) or macular edema after branch retinal vein occlusion (BRVO). This phase 2 randomized, dose-masked trial includes four patient groups, with participants randomly assigned to receive either a low or high dose of EYE103. Some groups include treatment-naïve participants, while others involve incomplete responders, including a group receiving EYE103 combined with aflibercept, a standard anti-VEGF medication. Participants will receive three injections of EYE103 in the study eye, spaced four weeks apart. Those in the combination therapy group will receive an additional aflibercept injection on the first day. The study will be conducted in sequential cohorts, with each group receiving their assigned treatment dose. Participants will have safety and effectiveness assessments at each injection visit, with some returning two weeks post-injection for extra evaluations. During the study, participants will undergo vision tests using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart and eye examinations such as slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure retinal thickness. The main outcome is the change in best-corrected visual acuity at week 12. The study concludes at the week 12 visit, which marks the end of participation for all enrolled individuals.

Researchers are studying the effects of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in people aged 60 and older who have geographic atrophy caused by age-related macular degeneration. This Phase 2, randomized, placebo-controlled, and masked study aims to evaluate how well this combination works, its safety, tolerability, and how the drugs affect the body. The study is sponsored by Apellis Pharmaceuticals, Inc. and involves multiple medical centers. Participants will be randomly assigned to one of three groups: two experimental groups receiving different doses or frequencies of APL-3007 with pegcetacoplan, and a placebo group receiving placebo injections along with pegcetacoplan. The treatments involve multiple doses over the study period. The study eye will be carefully selected based on vision and lesion characteristics to receive the assigned treatment. During the 12-month study, participants will undergo various assessments including AI-based imaging scans to measure changes in retinal pigment epithelium (RPE) lesions, photoreceptor degeneration, and visual acuity. Safety will be monitored through adverse event reporting and lab tests. Other measures include serum C3 levels and functional vision tests under different lighting conditions. Participants will adhere to the study visit schedule and complete all required evaluations to help researchers understand treatment effects and safety.

Researchers are evaluating corneal endothelial cells in people with neovascular age-related macular degeneration (nAMD) who are treated with the Port Delivery System (PDS) refilled every 24 weeks. This Phase IV study is open-label and multicenter, aiming to assess changes in corneal endothelial cell density and other eye health measures in participants receiving this treatment. Participants will have the PDS implant surgically placed in the study eye at the beginning of the study. The implant is filled with a ranibizumab solution before insertion and then refilled every 24 weeks. Supplemental ranibizumab injections may also be given if needed. The study monitors the participants during the treatment period, which lasts up to approximately one year. During the study, participants will undergo exams including specular microscopy to measure corneal endothelial cell density, visual acuity tests, and other eye health assessments at baseline, 24 weeks, and 48 weeks. Researchers will track any serious or special ocular adverse events, device effects, and other safety outcomes. Participants are followed closely to understand the effects of the PDS implant and treatment on eye structures over time.

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 evaluating the effectiveness of EYP-1901, a tyrosine kinase inhibitor, compared to Aflibercept in treating diabetic macular edema (DME). This phase 3, randomized, double-masked study aims to assess how well these treatments improve vision in participants with DME, a condition related to diabetic retinopathy that affects the central part of the retina. Participants will receive intravitreal injections of either EYP-1901 or Aflibercept. The study is designed with parallel groups and a quadruple masking approach, meaning neither participants nor researchers will know which treatment is given. The treatments will be administered according to the study schedule, with monitoring throughout the trial period. During the study, participants will undergo assessments including measuring best corrected visual acuity (BCVA) at 52 and 56 weeks to evaluate changes in vision. The study will also track the rate of injections needed by week 56. Safety and treatment effects will be monitored throughout the trial, which is expected to continue until October 2028.

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 previous related studies or certain visits in Study WR42221. It also includes two sub-studies: 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 receive the PDS implant with ranibizumab 100 mg/mL and undergo scheduled refill-exchanges every 24 weeks, with some switching to every 12 weeks later in the study. The sub-studies involve specific procedures such as TPC with laser treatment for hemorrhage prevention and re-implantation followed by refill-exchanges. Treatment schedules and visit frequencies vary depending on the participant's previous study involvement and sub-study enrollment. During the study, participants attend regular visits for eye exams, imaging, and assessment of visual acuity using the ETDRS chart. Researchers monitor for ocular and systemic side effects, device-related adverse events, and changes in eye structure and vision. The study duration can be up to 240 weeks, with the sub-studies having shorter follow-up periods. Safety, tolerability, and visual function are carefully tracked throughout the study and its extensions.

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 (TAU+AI). 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 evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating the long-term safety and effectiveness of revakinagene taroretcel-lwey (NT-501), an intraocular implant, in adults with macular telangiectasia type 2 (MacTel) who previously participated in Phase 1, 2, or 3 clinical studies. This Phase 4, global, multicenter, open-label extension study also includes participants who previously had a sham procedure and now elect to receive the NT-501 implant in this trial. The study has three groups: Arm 1 follows participants who received NT-501 in a Phase 3 study, Arm 2 follows those implanted in Phase 1 or 2 studies, and Arm 3 includes participants who had the sham procedure and will now receive the NT-501 implant. Arms 1 and 2 are observational with no new treatment given, while Arm 3 involves surgical implantation of NT-501 in eligible eyes. The implant releases a neurotrophic factor continuously to potentially support retinal health. Participants will have regular assessments including eye exams and imaging to monitor safety and vision changes. Researchers will track adverse events and measure vision loss, retinal sensitivity, reading speed, and quality of life using questionnaires at baseline, perioperative points, and annually for up to five years. The study aims to provide detailed data on long-term outcomes and safety for participants with MacTel receiving or previously receiving NT-501.