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.
Age-related Macular Degeneration (AMD) is a leading cause of vision impairment in the elderly and substantially affects the quality of life of an individual. Although the exact pathophysiological mechanisms behind the disease are multifactorial and complex, several genetic and environmental risk factors are associated with AMD, such as age, cigarette smoking, hypertension, abdominal obesity, dietary fat, and low physical activity. Geographic Atrophy (GA) is the late stage of dry AMD(d-AMD). GA is a slow but inexorably progressive disease that causes irreversible blindness over time. Several new non-invasive tools such as Fundus Autofluorescence (FAF), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A) are being used to enable early diagnosis and follow up in these patients. Despite these advances, there are currently no approved treatments for GA that can replace the damaged RPE, photoreceptors, or outer retinal layers. In recent years, stem cell replacement therapy is being evaluated as an alternative to treat d-AMD. In the pursuit to find a promising solution for d-AMD, which is an unmet medical need globally, Eyestem has been striving to develop a safe and effective stem-cell based therapy. Theoretically, human induced pluripotent stem cells(hiPSCs) derived Eyecyte-RPE™, developed by Eyestem can help replace the damaged or lost retinal pigment epithelial (RPE) cells and potentially enable tissue regeneration in the diseased retina. In addition, stem cells can perform multiple functions, such as immunoregulation, prevention of apoptosis in sensory neurons, and secretion of neurotrophic factors. The latest stem cell transplantation studies performed by other research groups has been able to demonstrate that this therapy has a promising approach to restore visual function in eyes with degenerative retinal diseases. The results of the pre-clinical safety and efficacy studies with Eyecyte-RPE™ have been very encouraging. It has been shown to provide significant beneficial effects on the degenerating retina in animals without any significant safety concerns, suggesting that this therapy may have substantial therapeutic value in d-AMD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Eyecyte-RPE™ is a suspension of hiPSCs (human induced Pluripotent Stem Cells) derived Retinal Pigment Epithelial Cells
Shri Ganapati Netralaya
Jālna, Maharashtra, India
RECRUITINGAll India Institute of Medical Sciences
Delhi, New Delhi, India
RECRUITINGL V Prasad Eye Institute
Hyderabad, Telangana, India
RECRUITINGFundus Autofluorescence-
Overall change in the geographic atrophy (GA) lesion area of the study eye over time using Fundus Autofluorescence (FAF)
Time frame: Upto 12 months
Best Corrected Visual Acuity (BCVA)-Mean change from baseline in BCVA score in study eye and fellow eye.
Change from baseline over time in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The BCVA score (in letter units) will be reported.
Time frame: Upto 12 months
Spectral-Domain Optical Coherence Tomography (SD-OCT)-Mean change from baseline in the Geographic Atrophy (GA) area in study eye and fellow eye
Overall change in the GA lesion area of the study eye over time using SD-OCT
Time frame: Upto 12 months
Fundus Photography- Changes between study eye and fellow eye
Correlation assessment between quantitative metrics derived from Color fundus photography images
Time frame: Upto 12 months
Microperimetry-Mean change from baseline in mean sensitivity
Change from initial assessment over time in retinal sensitivity, as assessed by Microperimetry (MP)
Time frame: Upto 12 months
National Eye Institute-Visual Function Questionnaire Quality of Life score
Change over time in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Quality of Life (QoL) score
Time frame: Upto 12 months
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