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Age-Related Macular Degeneration clinical trials

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NCT ID: NCT06465212 Not yet recruiting - Clinical trials for Age-Related Macular Degeneration

Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision

PYRENEES
Start date: July 2024
Phase:
Study type: Observational

Office-based optometrist centres equipped with low-cost OCT devices can be used for screening of age-related macular degeneration. Matching next-door optometrist centres with clinical sites introduces a shared care service in an unprecedented and broad manner and offers timely and inclusive access to eye care for all citizens affected by the most frequent blinding disease in western countries. The aim of the study is to detect AMD in a next-door office-based setting on an individual level using low-cost OCT, through a telemedicine feedback loop. The specific aims of this study are: - Setting up a network of optometrist centres matched to clinical sites to perform shared care to protect eyesight in the elderly population. - Identify imaging biomarkers of age-related macular degeneration from OCT imaging. - Give a risk estimation of progression using a one-time low-cost OCT scan

NCT ID: NCT06458595 Not yet recruiting - Clinical trials for Age-related Macular Degeneration

Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Start date: June 28, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.

NCT ID: NCT06394232 Recruiting - Clinical trials for Age-Related Macular Degeneration

Safety & Efficacy of Eyecyte-RPEā„¢ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.

Start date: June 4, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD). The main questions it aims to answer are: - Safety and tolerability of the novel stem cell formulation - Potential efficacy of the novel stem cell formulation Participants will receive a single subretinal injection in their study eye and followed up for safety. This is an India only study and the product is developed indigenously.

NCT ID: NCT06391411 Active, not recruiting - Clinical trials for Age-Related Macular Degeneration

Effect of Micronutrient Supplementation on the Intestinal Microbiota in Patients With Age-related Macular Degeneration - The Gut-Retina-axis Study

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Age-related macular degeneration (AMD) is a leading cause of visual impairment in the elderly, characterized by multifactorial etiology. Recent evidence suggests a potential involvement of the gut-retina axis in AMD pathogenesis, prompting exploration into novel therapeutic strategies. The investigators assessed the effects of a micronutrient mix containing lutein, zeaxanthin, and saffron, recognized for their anti-inflammatory properties, on ophthalmological and microbial parameters in neovascular AMD (nAMD) patients. Thirty nAMD subjects were randomized to receive daily micronutrient supplementation along with anti-VEGF therapy or anti-VEGF treatment alone for 6 months. Ophthalmological assessments, anthropometric and biochemical measurements and stool samples were obtained pre- and post-treatment. Gut microbiota (GM) characterization was performed through 16S rRNA sequencing while short (SCFAs), medium (MCFAs) and long (LCFAs) chain fatty acids were analyzed with a gas chromatography-mass spectrometry protocol. nAMD patients exhibited reduced GM alpha diversity, altered taxonomic abundances and decreased total SCFA amount, coupled with elevated proinflammatory octanoic and nonanoic acids. Micronutrient supplementation led to improved visual acuity in comparison to the control group, along with the reduction in the total amount of MCFAs, metabolites exerting detrimental ocular effects. This study reveals compositional and functional imbalances in the GM of nAMD patients compared to healthy controls. Furthermore micronutrient supplementation demonstrated a potential to restore the gut-retina axis, suggesting its therapeutic efficacy in improving ocular outcomes in nAMD patients. These findings underscore the intricate interplay between the GM and ocular health, offering insights into innovative interventions for AMD management

NCT ID: NCT06381596 Recruiting - Clinical trials for Age-Related Macular Degeneration

Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

FPF in AMD
Start date: April 16, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is: - to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy Participants will undergo FPF imaging using the OcuMet Beacon system.

NCT ID: NCT06373731 Recruiting - Clinical trials for Age-Related Macular Degeneration

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

ReNEW
Start date: May 30, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared.

NCT ID: NCT06355830 Recruiting - Clinical trials for Age-Related Macular Degeneration

Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study

Imaging4iAMD
Start date: January 2, 2019
Phase:
Study type: Observational [Patient Registry]

Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD. Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC. Primary outcome: Identifying imaging predictors of iAMD progression.

NCT ID: NCT06351670 Not yet recruiting - Clinical trials for Age-Related Macular Degeneration

Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

SUDETES
Start date: July 2024
Phase:
Study type: Observational

The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are: - Identify and quantify focal and global alterations in the retina in regard to disease progression. - Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging. - Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD - Enhance the ability to classify AMD using artificial intelligence in addition to traditional models. All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures: - Scanning Laser Fundus Photography - Color Fundus Photography (CFP) - Optical Coherence Tomography (OCT) - Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out. No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label.

NCT ID: NCT06351657 Not yet recruiting - Clinical trials for Age-Related Macular Degeneration

Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

APENNINES
Start date: July 2024
Phase:
Study type: Observational

The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are: - Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging. - Identify and quantify focal and global alterations in the retina in regard to disease progression. - Evaluate the monitoring of AMD progression using approved AI algorithms. All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures: - Scanning Laser Fundus Photography - Color Fundus Photography (CFP) - Optical Coherence Tomography (OCT) - Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out. No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label.

NCT ID: NCT06347107 Recruiting - Clinical trials for Age-Related Macular Degeneration

Robotic Subretinal tPA Injection Study

RoTIS
Start date: April 2024
Phase: N/A
Study type: Interventional

In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following: - The robotic stabilizer (prototype - FAMHP approval received) - 41G subretinal needle (CE marked - used within label) - Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes. As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review.