Burleson

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

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 safety and effectiveness of Ixoberogene Soroparvovec (Ixo-vec) for treating neovascular (wet) age-related macular degeneration (nAMD) in adults aged 50 years and older. This Phase 3, multi-center, randomized, double-masked study compares a single intravitreal injection of Ixo-vec with an active comparator, Aflibercept. The study focuses on a broad population including both treatment-naïve and treatment-experienced participants, aiming to assess if Ixo-vec is not less effective than the comparator in improving vision. Participants will receive one intravitreal injection of either Ixo-vec or Aflibercept. Ixo-vec is a gene therapy designed to reduce the treatment burden by potentially decreasing the need for frequent injections that are common in current anti-VEGF treatments for nAMD. The study includes a screening period followed by treatment administration and ongoing safety and efficacy assessments. During the study, participants will undergo regular evaluations including measurements of best corrected visual acuity (BCVA) at baseline and at Weeks 52 and 56 to monitor changes in vision. Safety, tolerability, and treatment response will be closely observed throughout the study duration. Researchers will also monitor anatomical responses to therapy and overall eye health through clinical assessments and adherence to eye drop use as required by the protocol.

Researchers are evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.

Researchers are evaluating a new mammography device to determine its safety, effectiveness, and usefulness in breast cancer screening and diagnosis. The study aims to support further technology development of this investigational mammography technology by collecting real-world clinical data. Women who need a screening or diagnostic mammogram or breast biopsy will have an exam using the new investigational mammography device. This device will be tested to see if it can safely acquire mammograms and provide images of clinically acceptable quality over a period of four years. Participants will undergo mammograms with the investigational device, and researchers will assess the image quality and safety of the device throughout the study. The evaluation period lasts up to four years, during which the device's clinical utility in breast imaging will be closely monitored.

Researchers are evaluating the safety and lasting effects of AR-14034 Sustained Release (SR) implant in people with neovascular age-related macular degeneration (nAMD). This study has two stages, starting with a dose-escalation phase to assess safety and preliminary effects, followed by a randomized comparison with an approved treatment called aflibercept. The trial is designed as a Phase 1/2 study to better understand how well AR-14034 SR works and how long its benefits last compared to standard therapy. In Stage 1, about 10 participants will receive one of two dose levels of AR-14034 SR via an intravitreal implant and be followed for 48 weeks to monitor safety and early treatment response. In Stage 2, approximately 130 participants will be randomly assigned to one of three groups: one injection of AR-14034 SR, two injections of AR-14034 SR, or aflibercept injections as currently labeled. This stage lasts 56 weeks, followed by a 16-week open-label extension phase where participants continue to be observed. Participants will attend multiple visits throughout the study to assess visual acuity using standard eye charts and monitor safety. Researchers will collect data at baseline, Week 44, and Week 48 to measure changes in vision. Additional assessments include eye exams and evaluations for any side effects during and after treatment. The total duration for participants ranges from 48 to 72 weeks depending on the stage and extension phase involved.

Researchers are conducting a Phase 1/2a open-label study to assess the safety of VOY-101, a biological therapy, in patients with advanced non-neovascular age-related macular degeneration (AMD), including geographic atrophy. This study focuses on patients aged 60 years and older who have well-defined geographic atrophy related to AMD without signs or history of macular neovascularization. The trial aims to understand the effects of escalating doses of VOY-101 given as a single injection in one eye. Participants will receive a single, unilateral intravitreal injection of VOY-101 at increasing dose levels in different cohorts to evaluate safety. The study includes a dose escalation phase in Phase 1 followed by a Phase 2a portion to further monitor effects. The treatment is administered directly into the eye, and patients will be closely observed throughout the study. During the study, participants will undergo eye exams, including ETDRS best-corrected visual acuity (BCDVA) testing and ophthalmic imaging to monitor retinal health. The main outcome measured is the overall effect of the treatment on retinal structure at Week 48. Participants must be able and willing to attend scheduled visits for treatment and follow-up assessments. Safety and treatment effects will be carefully tracked throughout the study duration.

Neovascular age-related macular degeneration (nAMD), also called "wet" AMD, involves abnormal growth of new blood vessels in the retina, the light-sensitive tissue at the back of the eye. This Phase 3b study is evaluating how safe and effective Surabgene Lomparvovec (ABBV-RGX-314), an investigational gene therapy, is in treating adults aged 50 and older who have previously been treated for nAMD. Approximately 561 participants will be enrolled at about 150 sites worldwide to compare different treatment approaches in a real-world setting. Participants will be randomly assigned to one of three groups. Two groups will receive a single subretinal injection of Surabgene Lomparvovec, while the third group will receive Ranibizumab injections as needed. Ranibizumab is given as an intravitreal injection into the jelly-like tissue inside the eye, whereas Surabgene Lomparvovec is injected between the retina and the back of the eye. The assessment period begins two weeks before treatment and continues for up to 5 years, allowing long-term monitoring of treatment effects. Participants will attend monthly visits at a hospital or clinic to monitor their eye health. These visits include medical assessments, blood tests, side effect checks, and questionnaires. Researchers will measure the annualized rate of anti-VEGF injections needed and record any adverse events over the 5-year period. The study involves a higher treatment burden than standard care, but aims to gather detailed information on long-term vision preservation and safety.