Macular Degeneration

Researchers are evaluating a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope. The study focuses on adults undergoing eye surgery for corneal, retinal, or other ocular diseases. The goal is to assess how easy and safe the 4D MIOCT system is to use during various anterior and posterior segment eye surgeries and to visualize the eye's structures effectively. The 4D MIOCT device is integrated into the Zeiss Artevo 800 surgical microscope and includes an investigational 3D OCT scanner. This imaging system will be used during the participants' clinically-indicated eye surgeries without any additional treatment or surgical intervention for research purposes. The study is observational, capturing images during standard ophthalmic microsurgery and comparing them to other clinical images obtained as part of usual care. Participants will have their eye images recorded during surgery using the 4D MIOCT device. Researchers will also review medical records from up to three previous eye care visits to gather clinical data, including ocular health and prior treatments. The images and data will be analyzed after surgery to evaluate the device's performance and explore whether it provides new information beyond existing clinical imaging. There is no extra risk to participants beyond their scheduled surgery.

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.

Researchers are evaluating the safety, early effectiveness, immune response, and how the body processes SKG0106 in patients with neovascular age-related macular degeneration (nAMD). This Phase 1 study focuses on people aged 50 and older who have active choroidal neovascularization (CNV) related to AMD and who have previously responded to anti-VEGF treatments. The study involves a single intravitreal injection of SKG0106, a gene therapy product based on a recombinant adeno-associated virus (AAV) vector. This open-label trial includes dose escalation to assess safety and immune response after the injection, with close monitoring for adverse events and drug behavior in the body. Participants will be monitored for up to 48 weeks to evaluate dose-limiting toxicities during the first 4 weeks and to track any ocular or systemic adverse events throughout the study. Researchers will assess eye health, immune reactions, and treatment effects using clinical exams and safety tests to understand SKG0106's impact and tolerability in this patient group.

Researchers are evaluating the safety and effectiveness of a new light therapy called reSEES to treat intermediate age-related macular degeneration (AMD). The study combines two laser-light treatments, photothermal and photobiological techniques, which are already known to be safe. This investigational device aims to explore the combined therapeutic effects of these two techniques. The primary goal is to confirm the safety of reSEES, while also studying its impact on the progression of intermediate AMD over one year. Participants will receive nine treatments over three weeks during a loading phase. Treatments include selective micropulse laser (SMPL) on days 0, 7, and 14, and photobiomodulation (PBM) on days 0, 3, 7, 10, 14, and 17. Treatment sessions occur twice weekly, with two treatments given on the first visit of each week (SMPL followed by PBM), and PBM alone during the second visit. After treatment, participants will have three follow-up visits at 18, 24, and 54 weeks to monitor progress. During the study, participants will attend a total of 10 visits over 52 weeks. Ophthalmic exams and safety checks are done at screening, treatment days, and follow-up visits. Researchers will measure the absence of laser-light spots using specialized imaging and monitor any treatment-related adverse events. Additional assessments include retinal changes, blood vessel health, vision function, and patient well-being. Health status, medical history, and medications will be regularly reviewed to support study safety and data quality.

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Researchers are investigating new treatment options for neovascular age-related macular degeneration (NVAMD), a condition affecting the eyes. Standard treatments like aflibercept do not work for everyone, so this trial is studying a medicine called tiespectus (also known as MK-8748 or EYE201) to see if it can effectively treat NVAMD. This is a pivotal Phase 2/3 randomized, double-masked, multicenter study comparing tiespectus to aflibercept. Participants will receive treatment by intravitreal injection directly into the eye. The study has three groups: one receiving tiespectus, another receiving aflibercept (2 mg), and possibly a third comparator group as part of the design. The study aims to assess the efficacy and safety of these treatments in people newly diagnosed with NVAMD. During the study, participants will be monitored for changes in their best-corrected visual acuity (BCVA) using standard eye charts from the start of the study to one year later. Researchers will perform regular eye exams and safety assessments to track treatment effects. Participation involves follow-up visits over at least one year to evaluate vision changes and treatment safety in detail.

Diabetic macular edema (DME) is a complication of diabetic retinopathy that causes retinal thickening near the center of the macula, leading to vision loss. This condition results from damage to the blood-retinal barrier due to diabetes, causing leakage and swelling in the retina. The study focuses on evaluating the efficacy and safety of ranibizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), which plays a key role in increasing retinal vascular permeability and edema. This randomized, double-blind, parallel study will include 70 patients with DME. Participants will receive three doses of 0.5 mg intravitreal injections of either the test product (Ranibizumab 10mg/ml Injection by Incepta) or the reference product (Lucentis) every four weeks, on Day 0, Week 4, and Week 8. After the first injection, a safety visit will be conducted 48 hours later, with additional safety follow-ups before each injection and 48 hours after the second and third injections. The final visit will occur at Week 12 for efficacy and safety evaluation. During the study, participants will undergo assessments including best corrected visual acuity (BCVA) and central subfield thickness (CST) measurements at baseline and Week 12. Safety will be closely monitored throughout the study with regular visits and ocular examinations. The total participation duration is approximately 12 weeks, during which researchers will evaluate changes in vision and retinal swelling to compare the two ranibizumab treatments.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

This research focuses on patients with wet age-related macular degeneration (wAMD) who were previously treated with the EXG102-031 injection in an earlier gene therapy trial. The study aims to evaluate the long-term safety and effectiveness of this treatment through extended monitoring. It is designed as a follow-up to the original trial, emphasizing ongoing observation rather than new treatment administration. Participants will not receive any new interventions during this study, as it is observational in nature. The long-term follow-up includes scheduled visits every two months during the first two years after treatment, then every six months from the third to the fifth year. This schedule allows for continuous safety monitoring and assessment of the treatment's lasting effects. Throughout the study, participants will undergo regular evaluations to monitor for any serious or common adverse events over four years. These assessments will help researchers understand the types, severity, and frequency of any side effects. The study involves up to five years of follow-up, providing extensive data on the treatment's long-term safety and patient well-being.

Researchers are conducting a long-term observational study to evaluate the safety and effectiveness of SKG0106 in treating patients with neovascular (wet) age-related macular degeneration (nAMD). This study follows individuals who completed earlier related clinical trials, focusing on ongoing monitoring for up to five years after receiving the SKG0106 injection. The goal is to gather detailed information on the treatment’s impact and any potential side effects over an extended period. The study involves no new interventions but includes regular safety and efficacy assessments for participants who previously received SKG0106. These assessments will happen throughout the five-year follow-up, allowing researchers to observe the long-term outcomes without altering the patients’ treatment plans. The observational nature of the study means it focuses on the natural progression and response to the existing treatment. Participants will undergo various evaluations during the follow-up period to monitor eye health and overall safety. Researchers will track the type, severity, and occurrence of any ocular or systemic adverse events, including serious or special interest events, for up to five years after the initial SKG0106 injection. This thorough monitoring aims to provide comprehensive data on treatment safety and patient well-being over time.