Ladson

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 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 the safety and effects of a one-time intravitreal injection of SAR402663 in adults aged 50 to 90 with neovascular age-related macular degeneration (nAMD). This Phase 1/2 study involves two parts: an initial dose escalation phase to test different dose levels, followed by a dose expansion phase where participants receive one of two selected doses. The study aims to assess how well SAR402663 works and its safety over time. Participants receive a single injection of SAR402663 into one eye on Day 1. In Part I, multiple dose levels will be tested in different groups to find the best doses. In Part II, participants are randomly assigned to receive one of two doses chosen from Part I results. Both participants and researchers will not know which dose is given. After the injection, participants will be regularly assessed for 12 months, then enter an extended follow-up period lasting up to five years to monitor long-term safety and treatment effects. During the study, participants will undergo various eye exams and safety assessments, including vision tests and monitoring for any adverse events. Researchers will measure changes in visual acuity and eye health, track the need for additional anti-VEGF treatments, and observe any side effects from the injection. Laboratory tests and vital signs will also be monitored throughout the first year. The extended follow-up phase will continue safety and durability checks over several years, ensuring thorough observation of participants' responses to the treatment.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy (GA), a late stage of Age-related Macular Degeneration (AMD) that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups: one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

Researchers are evaluating the effectiveness and safety of a single injection of AURN001 compared to a placebo in adults with corneal edema caused by corneal endothelial dysfunction. This randomized, double-masked Phase 3 study focuses on improving vision in participants who have this eye condition and may require surgery. Participants will receive either a single dose of AURN001 or a single dose of a placebo, both injected into the anterior chamber of the eye. The study uses a quadruple masking design to ensure unbiased results, comparing these two groups to assess changes in vision and corneal thickness over six months. During the study, participants' best corrected visual acuity (BCVA) and central corneal thickness (CCT) will be measured at the start and again at six months. The main outcome is the percentage of participants who improve their vision by at least 15 letters on the ETDRS scale at six months. Safety and other changes in eye health will also be monitored throughout the trial, which is expected to continue until January 2028.

Researchers are evaluating the safety and effectiveness of a gene therapy called Ixoberogene Soroparvovec (Ixo-vec) compared to a standard treatment called aflibercept in people with neovascular (wet) age-related macular degeneration (nAMD). This Phase 3 study involves participants who have not been treated before or have prior treatment experience. The study focuses on measuring changes in best corrected visual acuity (BCVA) at one year after treatment to see how well Ixo-vec works compared to aflibercept. Participants will receive either a single intravitreal injection of Ixo-vec or a series of injections of aflibercept. All participants get three monthly aflibercept doses as a loading phase, followed by either a single Ixo-vec injection at Week 1 with sham injections every 8 weeks, or sham injection at Week 1 with aflibercept injections every 8 weeks. This design allows comparison between the gene therapy and the active drug over a 56-week period. Throughout the study, participants will have regular eye exams to measure visual acuity and retinal thickness, and researchers will monitor safety and treatment effects. Assessments include visual function questionnaires and imaging to track changes in retinal anatomy. The study lasts more than a year, with key outcomes measured at Weeks 52 and 56. Safety, tolerability, and vision changes will be carefully reviewed during this time.

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 ABBV-RGX-314, a one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD), a condition causing vision loss due to new, leaky blood vessels in the retina. Wet AMD affects millions across the United States, Europe, and Japan. Current treatments involve frequent anti-VEGF injections, which can be burdensome and may lead to decreased vision over time. This Phase 3, randomized, partially masked clinical trial compares two doses of ABBV-RGX-314 against the standard anti-VEGF therapy aflibercept to assess safety and effectiveness. Participants will receive either a single subretinal injection of ABBV-RGX-314 at one of two dose levels or intravitreal aflibercept injections approximately every eight weeks after initial monthly doses. The study includes about 714 participants assigned to one of three groups. A bilateral treatment substudy at select U.S. sites will evaluate safety and efficacy of bilateral ABBV-RGX-314 in up to 15 participants over at least 50 weeks. During the study, participants will undergo regular eye exams to measure vision changes using best-corrected visual acuity (BCVA) and retinal thickness via imaging. Researchers will monitor treatment safety by tracking ocular and overall adverse events, supplemental anti-VEGF injections needed, and gene therapy concentrations in eye fluid and blood. The main outcome is the change in vision at 54 weeks, with extended follow-up to 108 weeks for some participants. Participants will be monitored closely to assess the ongoing effects and safety of the treatments.

Neovascular age-related macular degeneration (nAMD), or "wet" AMD, involves abnormal growth of new blood vessels in the retina, the light-sensitive tissue at the back of the eye. Researchers are evaluating the safety and effectiveness of Surabgene Lomparvovec (ABBV-RGX-314), an investigational gene therapy, for treating adults aged 50 and older with previously treated nAMD. The study aims to compare this gene therapy to the current standard treatment, Ranibizumab, to better understand long-term visual preservation and treatment burden. 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 via intravitreal delivery. The study includes an assessment period starting two weeks before randomization and lasting up to five years. During this time, the treatment effects and safety will be monitored closely. Participants will attend monthly visits at a hospital or clinic, where medical assessments, blood tests, and questionnaires will be conducted to monitor side effects and treatment impact. Researchers will measure injection frequency, adverse events, and changes in visual acuity over up to five years. This long-term follow-up helps assess the safety and potential benefits of the gene therapy compared to standard care.

Researchers are investigating the effects of balcinrenone combined with dapagliflozin compared with dapagliflozin alone in patients with chronic heart failure (HF) and impaired kidney function who recently experienced a heart failure event. This Phase III international study aims to evaluate the impact on cardiovascular death and heart failure events, including hospitalizations and events without hospitalization. The study is led by AstraZeneca and involves multiple centers worldwide. Participants will be randomly assigned to one of three groups: a combination of balcinrenone and dapagliflozin at two different doses or dapagliflozin alone. Each participant will take one capsule and one tablet once daily, with placebos provided to maintain blinding. The study lasts about 22 months, including screening, a 20-month blinded treatment period, and a one-month follow-up during which all receive dapagliflozin openly. During the study, participants will be monitored for cardiovascular death and heart failure events, using measures such as hospitalizations and symptom assessments. Regular evaluations will track the timing of these events over approximately 38 months. Safety and health status will be followed closely, with a final follow-up phase to assess ongoing outcomes after the blinded treatment period.