Clinical Research Directory

Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages

This study investigates the prognostic value of macular neovascularization (MNV) subtypes in patients treated with pneumatic displacement for submacular hemorrhage. The researchers will compare anatomical and functional outcomes (visual acuity) between PCV, RAP, and other MNV forms within a Caucasian cohort to identify subtype-specific predictors of recovery.

Study in Human iPSCs-derived RPE Cells Transplantation for Late-Stage AMD

Phase I Study of the Safety and Preliminary Efficacy of Human induced pluripotent stem cells-derived Retinal Pigment Epithelial (HiPSC-RPE) Cells Subretinal Transplantation in Late-Stage Age-Related Macular Degeneration(AMD) Patients

Repeated Low-Level Red-Light Therapy in Dry Age-Related Macular Degeneration

This prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in patients with dry age-related macular degeneration (AMD). The primary objective is to assess the effect of RLRL therapy on visual function in patients with dry AMD, while the secondary objective is to evaluate its safety and tolerability. Seventy-four participants aged 50 years or older with dry AMD will be enrolled and randomly assigned in a 1:1 ratio to either the active RLRL intervention group (using the full device power) or the control group (sham device at 10% power). Group assignments will be masked to both participants and investigators. Participants will administer the treatment at home twice daily (3-minute sessions, with at least a 4-hour interval between sessions) over five consecutive weekdays each month for three months. A video tutorial will guide device usage, with ongoing support from the research team. Before enrollment, participants will undergo a comprehensive assessment, including ocular and family history review, OCT, and fundus photography to confirm eligibility. Evaluations will occur at baseline, 1 month, and 3 months, covering best-corrected visual acuity (BCVA), slit-lamp examination, OCT, OCT angiography (OCTA), fundus autofluorescence (FAF), contrast sensitivity, color vision, electroretinography (ERG), visual-related quality of life (VRQL) questionnaires, and adverse event monitoring. The primary outcome is the mean change in BCVA from baseline to 3 months. Secondary outcomes include changes in central drusen thickness, geographic atrophy (GA) size and progression, choroidal blood flow, contrast sensitivity, ERG responses, and VRQL scores. Given the limited treatment options for dry AMD, which are primarily focused on lifestyle changes and nutritional supplements, this study investigates the potential of RLRL therapy as a novel, non-invasive treatment. The results may address the unmet medical need in dry AMD, potentially slowing disease progression and improving patients' quality of life.

A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses

This is a Phase 1 study to evaluate the safety, tolerability, PK, and PD of ABF-101 in healthy participants and participants with age-related macular degeneration (AMD).

Comparison of the Sensibility of Swept Source Optical Coherence Tomography Devices in the Detection of Neovascularisation in Large Pigment Epithelium Detachments

The goal of this observational study is to compare swept source optical coherence tomography devices ability to detect macular neovascularisation when there is a large pigment epithelium detachment higher than 250 microns

"My Eyes, My Light": Amar Chokh, Amar Alo

Eye disease affects 2.2 billion people globally, which in turn adversely affects schooling, economic productivity, and participation in social life. The primary conditions contributing to visual impairment and blindness include cataracts, age-related macular degeneration (AMD), glaucoma, diabetic retinopathy (DR), refractive error, and presbyopia. Early detection of eye disease can provide substantial benefits in prompting treatment to reduce progression and mitigate disability. Compared with other regions, South Asia has the most cases of visual impairment due to cataracts and uncorrected refractive error. The combination of poverty, poor living and working environments, and limited health care access have long endangered eye health in Bangladesh. Coastal Bangladesh is particularly impacted by eye disease due to economic deprivation and limited healthcare access. The coastal population mostly works in fishing and agriculture, have prolonged sunlight exposure, and inadequate occupational eye protection. This low-lying region, with 35 million people, is especially vulnerable to climate disasters and global warming. High rates of chronic disease, especially diabetes mellitus Type 2 and hypertension, coupled with limited screening and treatment, shape the area's health profile, with the increasing prevalence of eye diseases such as DR, glaucoma, and visual impairment. To address the issues of poor health, accessibility, and affordability of eye care, Artificial Intelligence (AI) applications, such as Artificial Intelligence (AI)-assisted fundus imaging, can be applied in eye screening. Medical AI applications have the potential to improve the quality and efficiency of healthcare, reduce healthcare costs, optimize treatment plans, and bolster the development of primary healthcare. They can identify presumptive DR, hypertensive retinopathy (HR), AMD, and glaucoma by analyzing the retina and optic disc of fundus images with moderate accuracy and high efficiency, thus helping address the lack of local eye care professionals. Data Yakka developed a human-AI collaboration that delivers affordable and transformative community-based eye screening to underserved communities in the coastal Bangladesh region of Char Fasson. The "Amar Chokh Amar Alo" (My Eyes, My Light) initiative creates and implements comprehensive eye screening that combines AI-assisted eye screening and grassroots partnerships with trusted non-health non-governmental organizations (NGOs). It has three objectives: 1) Enhancing accessibility and affordability of eye screening; 2) Supporting high quality and efficient treatment of those problems detected via screening, 3) Collecting fundus images to refine or train AI algorithms in the future. This project was designed to evaluate the feasibility, performance, equity, and cost of this model of eye screening and its implications for global eye disease. The implementation of participant recruitment, data collection, screening, and follow-up was separated into twelve steps. This standardized framework ensured the integration of screening with data collection and follow-up eye care services. Based on risk stratification by diabetes, hypertension, age 50+ years, and/or optometrist recommendation, fundus imaging was offered selectively to higher-risk patients.

The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in the elderly worldwide. The dry, non-exudative form of the disease, although more common, is associated with gradual and significant decline in functional vision. Despite advancements in diagnostic and therapeutic approaches, a targeted intervention that improves the daily functionality of these patients is still lacking. One critical, yet often overlooked, factor that affects daily performance is lighting conditions. This study aims to objectively assess the impact of different lighting intensity levels on patients with advanced dry AMD during the execution of everyday activities. A total of 60 individuals will be evaluated (30 healthy controls over 60 years of age and 30 patients with clinically diagnosed advanced AMD, according to NICE and AREDS criteria). Participants will undergo ophthalmological assessment (visual acuity, contrast sensitivity, OCT/OCTA, autofluorescence), and their performance on five functional tasks (mobility, object grasping, sit-to-stand transition, obstacle avoidance, and hanging clothes) will be evaluated under eight lighting levels (20-300 lux) at a constant color temperature (4000K), in a specially designed laboratory equipped with motion and eye-tracking systems. The primary endpoint is overall performance, based on task completion time and errors, expressed on a custom performance scale (0-100). Secondary data include changes in pupil size as an indicator of visual adaptation. The study aims to determine the optimal lighting range that maximizes functional vision and improves the quality of life for patients with AMD.

Visual Rehabilitation and Depression in Visually Impaired Patients with AMD

Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status. Study design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia. Study procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9). Visit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings. Visit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety.

Retinal Investigation Using Optos OCT Device

Retinal investigation using OCT with control and diseased eyes