Mount Pleasant

Researchers are evaluating the effectiveness, safety, tolerability, and pharmacodynamics of multiple doses of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in patients aged 60 years and older diagnosed with geographic atrophy secondary to age-related macular degeneration. This Phase 2, randomized, placebo-controlled, multicenter, masked study focuses on measuring changes in retinal pigment epithelium lesions using advanced artificial intelligence-based SD-OCT imaging. Participants will receive either the combination of APL-3007 with pegcetacoplan (APL-2) or a placebo. The study includes a treatment period with multiple doses administered, aiming to assess the impact on geographic atrophy lesions over a 12-month period. Syfovre injections at 6-8 week intervals prior to enrollment are part of the inclusion criteria. During the study, participants will undergo various eye imaging assessments such as OCT and FAF to monitor lesion size and progression. Researchers will evaluate changes in lesions at month 12 compared to baseline. Safety and tolerability will be closely monitored through laboratory tests, clinical evaluations, and vaccination status requirements. The study duration includes regular visits for treatment administration and monitoring over at least one year.

This research aims to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. The study is a Phase 2 and Phase 3, dose-ranging, randomized, double-blind, placebo-controlled trial comparing BFB759, a biological treatment that blocks multiple pro-inflammatory cytokines, to a placebo. Participants have had hidradenitis suppurativa for at least one year and have disease that is not well controlled by antibiotics. Participants receive either BFB759 or a placebo in a blinded manner over the course of the study. The study lasts approximately 36 to 40 weeks during which the treatment's effects and safety are assessed. The trial evaluates the drug's impact on hidradenitis suppurativa symptoms and monitors for any adverse reactions. Throughout the study, participants attend regular visits to assess their condition and safety. Researchers monitor the efficacy of BFB759 from the start to Week 16 and Week 32. Participants are asked to follow study instructions carefully, attend scheduled visits, and avoid certain other medications. The trial includes adults aged 18 to 75 years and collects data on treatment effectiveness and safety over the full study period.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are evaluating the effectiveness, safety, and pharmacokinetics of the Port Delivery System (PDS) with ranibizumab compared to standard intravitreal ranibizumab injections in adults with diabetic macular edema (DME). This Phase III, multicenter, randomized study aims to compare PDS treatment every 24 weeks with injections every 4 weeks. A substudy will assess the safety of re-implanting the updated PDS and performing refill-exchange procedures in participants previously enrolled in the main study. Participants will receive either the PDS implant pre-filled with ranibizumab or intravitreal ranibizumab injections according to their assigned group. Treatments will be administered on a set schedule specific to each arm. The substudy involves re-implantation of the updated PDS and monitoring post-procedure. The PDS refill exchange is also part of the treatment plan for some participants. Throughout the study, participants will undergo assessments including vision tests using the ETDRS chart to measure changes in best-corrected visual acuity (BCVA). Safety will be monitored by tracking ocular and systemic adverse events, device-related effects, and any serious complications up to 72 weeks after treatment or re-implantation. The study evaluates both short-term and long-term safety and efficacy outcomes over the full duration of participation.

Researchers are evaluating the safety and effectiveness of combining femtosecond laser arcuate corneal relaxing incisions (AK) with Light Adjustable Lens (LAL) implantation to correct pre-existing corneal astigmatism in patients undergoing cataract or refractive lens exchange surgery. This Phase 4 study aims to compare this combined approach to established methods like arcuate keratotomy and toric intraocular lenses by using advanced femtosecond laser technology. The focus is on improving visual outcomes and patient satisfaction while monitoring for any adverse events. Participants will receive femtosecond laser-assisted arcuate corneal relaxing incisions to address astigmatism, along with implantation of the Light Adjustable Lens to replace the natural lens during surgery. Treatment requires paired arcs less than 45 mm in length. The study involves lens extraction followed by LAL implantation, with postoperative adjustments to achieve the desired refraction. During the study, participants will undergo scheduled preoperative and follow-up examinations to assess residual refractive astigmatism, visual outcomes, and patient satisfaction. Researchers will track the number of Light Adjustable Lens adjustments needed to reach the target refraction at 8 weeks after the last adjustment. Safety will be monitored by observing any adverse events throughout the study period.

Researchers are evaluating treatments for amblyopia in children aged 4 to 7 years. The study compares watching dichoptic movies or shows using the Luminopia virtual reality headset for 1 hour per day, 6 days per week, to traditional eye patching for 2 hours per day, 7 days per week. This Phase 3 trial aims to determine if the Luminopia treatment is not worse than patching in improving vision in the weaker eye over 26 weeks. Participants will be randomly assigned to either the Luminopia headset group or the patching group. Clinical assessments occur at 13 and 26 weeks after starting treatment. At 26 weeks, those initially assigned to patching who show less improvement may choose to try Luminopia therapy and continue follow-up visits at 39 and 52 weeks. Other participants will end the study at 26 weeks. During the study, children will have their vision tested at scheduled visits to measure changes in distance visual acuity in the amblyopic eye. Researchers will monitor treatment adherence and safety. The total participation can last up to 52 weeks for some children, with primary outcomes assessed at 26 weeks to evaluate vision improvement.

Researchers are evaluating treatments for amblyopia in children aged 8 to 12 years. The trial compares two types of dichoptic therapy delivered through virtual reality headsets—Luminopia presenting movies and shows, and Vivid Vision offering video games—against continued optical correction alone. The study aims to understand how these treatments affect visual acuity in the amblyopic eye over an 18-week period. Participants will be randomly assigned to one of three groups: Luminopia dichoptic treatment, Vivid Vision dichoptic treatment, or optical correction alone, all with optical correction as needed. Treatments are provided for 19 weeks, with dichoptic therapies involving daily sessions of either viewing or gameplay through a headset. If participants initially assigned to optical correction alone show insufficient improvement at 18 weeks, they may be re-randomized to receive one of the dichoptic therapies and followed up at 27 and 36 weeks. The study concludes for others at 18 weeks. During the study, participants undergo clinical assessments at 9 and 18 weeks after randomization to measure changes in visual acuity of the amblyopic eye using logMAR distance measures. Researchers monitor adherence to treatment, willingness to wear headsets and glasses, and optical correction stability. Safety and effectiveness are assessed by comparing visual outcomes across groups, with additional follow-up visits for some participants extending to 36 weeks total participation.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.