Erie

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease (DED) who have a specific TNFR1 genotype. This study aims to understand if licaminlimab can reduce the discomfort caused by DED. It is a Phase 2b/3, randomized, double-masked, and vehicle-controlled clinical trial conducted at multiple centers. Participants first use artificial tear eye drops three times daily for about 14 days as a run-in period. After this, they are randomly assigned to receive either licaminlimab ophthalmic solution or a placebo vehicle, both administered three times daily for 29 days. Licaminlimab is given as a 60 mg/mL eye drop solution, and the study compares its effects to the inactive vehicle solution. During the study, participants will have their ocular discomfort severity measured from the start to Day 29 to assess treatment impact, especially focusing on those with the specific genotype. Researchers will monitor safety and efficacy throughout. The study includes genotype testing and requires participants to have a recent physician diagnosis of Dry Eye Disease. The total participation involves initial run-in treatment followed by the randomized treatment period, with evaluations to capture symptom changes and safety.

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.

This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation (MESI). This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments: KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity (BCVA) over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation (MESI). The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments: an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups: one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone; the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

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 combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

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.