Oak Forest

Researchers are investigating the safety and effects of 4D-150 gene therapy in adults aged 50 and older with neovascular (wet) age-related macular degeneration (AMD) who are already receiving anti-VEGF treatment and have shown a clinical response. This Phase 1/2 trial includes dose-escalation and randomized, controlled, masked expansion phases, aiming to evaluate 4D-150 administered by intravitreal injection in one eye, with additional substudies assessing dosing in the second eye and vector shedding. Participants will receive a one-time dose of 4D-150 by injection into the study eye, followed by monthly assessments for 24 months to monitor safety and effectiveness. Those who receive 4D-150 will then enter a long-term follow-up period up to 5 years to assess ongoing safety and the duration of treatment effects. Substudies include one for contralateral eye dosing and another to characterize vector shedding, with participants monitored regularly for safety through one year and continuing long-term follow-up through year 5. Throughout the study, participants will undergo tests of visual and retinal function and structure, with assessments performed monthly initially and safety monitored for up to five years. Researchers will track treatment-emergent adverse events, serious adverse events, and any significant changes in safety parameters. Participants must comply with study procedures and visits, and males receiving 4D-150 will be advised to use barrier methods during intercourse for six months to prevent fluid transmission.

The study consists of the following periods: Screening (up to 60 days) and the Study Period (52 weeks post treatment).

This research aims to understand how avacincaptad pegol, a treatment approved in the US, is used for people with geographic atrophy caused by age-related macular degeneration (AMD). Geographic atrophy is an advanced stage of AMD where cells in the retina waste away, leading to worsening central vision and possible permanent vision loss. The study focuses on observing treatment patterns and safety in routine clinical practice rather than testing new effects. Participants in this study will receive avacincaptad pegol through intravitreal injections, which are injections into the eye. The study collects information from patients who have already been prescribed this treatment by their doctors. There is no experimental intervention from the study team, and treatment decisions are made by the patients' doctors. The study follows patients for up to 3 to 5 years, depending on when they join. While in the study, participants will have regular eye exams as part of their usual care. They will also complete surveys about their eye health at the start of treatment, every 6 months for the first 2 years, then annually afterward. Researchers will track treatment details like the number and dose of injections, treatment duration, reasons for stopping treatment, and patient characteristics. Safety and treatment patterns are monitored through medical records during and after treatment.

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 the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) at 100 mg/mL in people with neovascular age-related macular degeneration (nAMD). This study includes participants who have completed previous Phase II or Phase III studies or reached Week 24 in a related study but were not randomized. The study also explores two sub-studies: one assessing a laser treatment to reduce eye bleeding related to the PDS implant procedure, and another assessing the safety of re-implanting an updated PDS device. Participants receive the PDS implant with ranibizumab according to specific schedules in their study arms. The first sub-study uses transscleral photocoagulation with an Iridex laser system to reduce vitreous hemorrhages after implantation, enrolling about 55 participants. The second sub-study involves up to 100 participants in the United States who undergo re-implantation of the updated device and are followed for up to 72 weeks. Treatments and procedures are carefully monitored throughout. Participants undergo regular visits for up to 240 weeks to monitor for adverse events, including eye-related and systemic effects, severity, duration, and any device-related issues. The sub-studies also track specific complications like vitreous hemorrhages and adverse device effects during postoperative and follow-up periods. Safety assessments include eye exams, imaging, and evaluation of systemic health to ensure ongoing monitoring of participant well-being throughout the study.

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 treatment for adults aged 50 and older who have macular neovascularization caused by neovascular age-related macular degeneration (nAMD). This Phase 3 trial compares a single intravitreal injection of 4D-150 with the active control treatment EYLEA (aflibercept). The study aims to assess changes in visual acuity over one year to better understand the effects of these treatments on this eye condition. Participants are randomly assigned to receive either a single dose of 4D-150 injected into the eye on Day 1 or ongoing EYLEA injections at scheduled visits. The study includes adults who have either never received anti-VEGF therapy or have had up to four prior anti-VEGF injections with documented improvement. The condition must be active and confirmed by specialized eye imaging tests before enrollment. Throughout the 52-week study, participants will have regular assessments including vision tests measured by the ETDRS letter score, eye imaging, and clinical evaluations to monitor treatment effects and safety. Researchers will track visual acuity changes from the start of treatment and watch for any adverse effects. The study's main goal is to measure the average change in best corrected visual acuity at one year.

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.