Clinical Research Directory

Phase 1b/2a Study of EYC-0305 in Patients With Neovascular Age-related Macular Degeneration

This Phase 1b/2a study will primarily investigate the safety and tolerability of EYC-0305 delivered by intravitreal (IVT) injection every 24 weeks in patients with neovascular (wet) age-related macular degeneration (AMD). The pharmacokinetics (PK) and immunogenicity of EYC-0305, and the effect on disease activity and vision will also be evaluated.

MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.

Age-related macular degeneration (AMD) is the major cause of legal blindness in developed countries. Intermediate AMD represents the most frequent stage. However, it often evolves towards complicated stages, namely neovascular AMD or geographic atrophy (GA). Despite the available treatments, the visual outcome is highly heterogeneous. The scientific interest is growing regarding the assessment of neuroretinal changes in AMD. Although AMD is mainly considered an outer retinal disease, recent evidence suggests a major involvement of retinal glia and neurons, i.e. an involvement of the inner retina. This damage may remarkably affect the morphological and functional AMD outcome, subverting retinal signal transmission cascade and more clearly explaining the outcome of the disease. The main goal of this study is to perform a multidisciplinary, multicenter, both prospective and retrospective evaluation of neuroretinal degeneration in different AMD stages in preclinical and clinical models.

First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)

This is a first-in-human clinical trial evaluating the safety and tolerability of BETA-TT8 Ophthalmic Gel in people with wet age-related macular degeneration (AMD). Approximately 24 participants with stable wet AMD who have previously received at least three anti- Vascular Endothelial Growth Factor (anti -VEGF) injections will use the eye gel for up to 12 weeks at one of three dosing schedules (once, twice, or three times daily). Standard anti-VEGF treatment (aflibercept) will remain available if needed during the study. Participants who complete the initial 12-week treatment period may be invited to continue in an extension phase for up to 12 months to collect additional safety and treatment information.

4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment. Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.

Evaluation of PAN-90806 Eye Drops in Healthy Subjects

The goal of this clinical trial is to learn about the safety, tolerability, and systemic pharmacokinetics of PAN-90806 eye drops in healthy adults. It will also evaluate what medical problems participants may have when taking PAN-90806. The main questions it aims to answer are: Is PAN-90806 eye drops safe and well tolerated in healthy participants? What are the systemic pharmacokinetic characteristics of PAN-90806 after ocular administration? What medical problems or adverse events do participants have when taking PAN-90806? Researchers will compare PAN-90806 eye drops to a placebo (a look-alike eye drop that contains no PAN-90806) to evaluate the safety, tolerability, and systemic pharmacokinetics of PAN-90806. Participants will: Receive PAN-90806 eye drops or placebo eye drops once daily in both eyes, one drop per eye, on Day 1 and Days 3 to 7, for a total of 6 dosing days Stay at the study center during the inpatient dosing period and attend scheduled study visits for screening, admission, dosing, and discharge Undergo blood sampling for pharmacokinetic testing, as well as eye examinations, laboratory tests, vital signs assessments, physical examinations, and ECGs

Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, or Diabetic Retinopathy

This is a single-arm, multicenter study to evaluate clinical usability of a pre-filled syringe containing SCD411 in adult patients with neovascular Wet Age-Related Macular Degeneration (AMD), Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), or Diabetic Retinopathy (DR)

AI vs. Physician for Anti-VEGF Decision-Making: An RCT

We developed an artificial intelligence system, called QiLin, which was designed to assist anti-VEGF treatment decisions in retinal diseases. QiLin was trained and validated via over 20,000 optical coherence tomography images from multicenter datasets, demonstrating strong performance on both internal and external validation. To evaluate its real-world clinical utility, we conducted a randomized controlled trial that rigorously compares the accuracy of treatment decisions between a physician-only arm and an AI-assisted physician arm.

Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates

The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss. You were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT). This research study targets to recruit 200 participants from the Singapore National Eye Centre. This study comprises two cohort groups: Cohort 1(Suboptimal CAT scores/ Randomized Control trial) and Cohort 2 (Optimal CAT scores/Observation). If you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice. * MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers. * Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results. If you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.

Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration

The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile. Participants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and efficacy observations and/or continued treatment. Participants may receive additional treatment(s) if they meet specified criteria.

Switch From 2mg Aflibercept to 8mg Aflibercept in Patients With Neovascular Age-related Macular Degeneration

This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity.

Recurrence and Predictive OCT Biomarkers in Quiescent Neovascular AMD

Age-related macular degeneration (AMD) is the most common cause of severe visual impairment and blindness in elderly patients. The central part of the retina is called the macula and is very important for visual acuity. In wet AMD, blood vessels grow under the macula and leak fluid, which leads to swelling in the macula and vision loss. Patients who develop wet AMD are treated with injections into the eye. Today, the treatment can be stopped when the patient has reached an interval of six months between the injections, without showing any signs of disease activity. However, it is not unusual for the swelling in the macula to return and the injections then must be resumed. Today, it is not known exactly how many patients suffer from active disease recurrence, or at what point of time the recurrence usually happens. Furthermore, it remains unclear which patients are at a higher risk of active disease recurrence. Optical coherence tomography (OCT) is a simple and quick measurement method, similar to taking a photograph of the inside of the eye, to investigate whether there is swelling or other changes in the macula. With OCT, the retina is measured with infrared light. With OCT angiography (OCT-A), which is done in the same simple way, it is also possible to visualize the diseased blood vessels and other changes in the retina. Under the retina is the choroid layer of the eye, OCT can also be used to measure the thickness and circulation of the choroid. No large prospective studies have investigated changes on OCT, changes in the diseased vessels on OCT-A, choroidal thickness and choroidal circulation on OCT, and the risk of recurrence of disease requiring treatment in wet AMD. The study will be conducted as a prospective study at St. Erik's Eye Hospital, a total of 220 patients with wet AMD, where the treatment interval has been extended to 6 months without signs of disease activity, will be included in the study and followed for 18 months, i.e. up to two years after the last injection. Patients with disease recurrence during the follow-up period will be withdrawn from the study and resume treatment. The aim of the study is to see if there is a relationship between specific changes on OCT and OCT angiography and later recurrence in wet AMD, to investigate how many patients experience disease recurrence and to find out when the recurrence usually occurs. No previous prospective study has investigated these different parameters. Increased knowledge of how many patients experience recurrence of wet AMD requiring treatment, as well as a deeper understanding of which patients are at greater risk of recurrence, could have a major impact on the planned follow-up in this population. Furthermore, by improving the conditions for being able to identify recurrences earlier, the risk of irreversible vision loss could also decrease in this patient group.