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NCT07548944
Retinitis pigmentosa and similar degenerative diseases of the retina lead to progressive loss of vision. TES therapy with the CE-marked OkuStim® System is a treatment approved in the EU for slowing the progression of the disease. Patients increasingly report short-term subjective improvements in vision, which have not yet been systematically investigated. This exploratory study is conducted to determine whether these subjective short-term effects can be measured, and therefore also be quantified, by objective tests.
NCT07292987
This study explores whether adding early nurse-led and psychological support after the diagnosis of retinitis pigmentosa (RP) can improve patient experience and emotional well-being. RP is a rare, progressive eye disease often diagnosed after a long and difficult process, and receiving the diagnosis can be emotionally distressing. Eighty newly diagnosed adults will be randomly assigned to either usual care or an enhanced pathway that includes early follow-up with a nurse, structured emotional monitoring, and a psychologist visit at six months. The study aims to determine if this structured support improves patient satisfaction and reduces anxiety and depression compared with standard care.
NCT06789445
Study OpCT-001-101 is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.
NCT07265895
Inherited Retinal Diseases (IRDs) are a heterogeneous group of genetically based degenerative retinal disorders, representing a major cause of visual impairment and blindness in working-age adults. Despite the approval of the first gene therapy for RPE65-related IRD (voretigene neparvovec) in 2017, most IRDs remain untreatable, though many gene therapies are in development. Effective trial design and therapy development require a deep understanding of disease natural history and genotype-phenotype correlations. Over 270 IRD-associated genes are known (e.g., ABCA4, USH2A, RPGR, PRPH2, BEST1), each linked to distinct phenotypes and clinical progression. This retrospective study analyzes clinical, functional, and imaging data (Optical Coherence Tomography, Fundus Autofluorescence, Microperimetry) from a large, genetically characterized IRD cohort at the IRCCS Ospedale San Raffaele up to December 31, 2025. The aims are to describe natural history, define genotype-phenotype relationships, and identify structural and functional outcome measures useful for future clinical trial endpoints, supporting personalized prognosis and trial design.
NCT07266584
The objective of this study is to evaluate the efficacy and safety of the PRIMA Products in participants with inherited retinal degeneration affecting the macula (including but not limited to Stargardt disease, and Retinitis Pigmentosa). Eligible participants will be implanted with the PRIMA Stim implant. The participants will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA Products. The purpose of this study is to gather enough clinical data to support the clinical evaluation required for the continuous development to improve the PRIMA Products.
NCT07088705
Introduction Retinitis pigmentosa (RP) is the most common form of genetic retinal degenerative disease. The disease is progressive and leads to blindness and permanent disability within a few years of diagnosis. The etiology of RP is multifactorial. It combines genetic (multiple inheritance patterns) and environmental factors, which makes it difficult to develop effective causal therapy. Many potential methods of RP treatment have been described so far, but the lack of unequivocal evidence of the therapeutic effectiveness of these methods implies a lack of RP therapy standards. Few analyzes have shown that the use of a red subthreshold micropulse laser (SML) with a wavelength of 810 nm causes a neurostimulatory effect on the retina. The subsequent introduction of a yellow laser with a wavelength of 577 nm, dedicated to edema and ischemic retinal diseases, re-initiated a series of questions about the effectiveness of both therapies and the treatment protocols used. This fact emphasizes the need for further verification and optimization of SML treatment regimens in Poland, which has a chance to become a new, widely available, non-invasive standard of treatment independent of the genetic pattern. The aim of the project The main goal of the experiment is to verify the effectiveness of SML and determine the optimal treatment protocol for SML based on a detailed analysis of molecular changes of selected pro-inflammatory, neurotrophic and angiogenic factors (IL-1α, IL-1β, IL-2, IL-4, IL-5, IL- 6 IL-8, IL-10, IL-12 p70, IL-13, IL-17A, CXCL8 / IL-8, MCP-1 / CCL2, MIP-1α / CCL3, MIP-1β / CCL4, IL-8 / CXCL8, CCL5 / RANTES, IP-10 / CXCL10, GM-CSF, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-13, BMP-4, BMP-7, BMP - 9, TIMP-1, t-PA, PAI-1, NGF, EGF, TNF-α, TGF-β1, TGF-β2, FGF, EGF, G-CSF, GM-CSF, HGF, PDGF-AA, PDGF- AB / BB, VEGF, PAI-1, COL1A1, TSP-2, IFN-γ, N-cadherin, E-selection and P-selection) in tears and peripheral blood of patients with RP. Moreover, the project aims to personalize the assessed treatment regimens by determining the correlation between these changes and the genotype and dynamics of functional changes of the retina in the eyes from the RP subjected to single stimulation with yellow and red SML. Materials and methods The study group will consist of 60 adult patients with retinitis pigmentosa diagnosed on the basis of a characteristic clinical picture confirmed by genome analysis using the whole exome sequencing method and full-field electroretinoography (ERG). In randomized selection, one eye of each patient will be randomly assigned to be stimulated with red (30 eyes) or yellow (30 eyes) SML, and second eye will be assigned to the sham procedure. This will ensure a comprehensive comparative assessment of the effectiveness of both types of SML against each other and against a placebo. The tear film will be collected by wetting the Schirmer strips placed under the lower eyelid before SML (T0) and 28 days (T1), 3 months (T2) and 6 months (T3) after the laser stimulation. In addition, approximately 7.5 ml of peripheral venous blood will be collected at corresponding time points. The assessment of the dynamics of functional changes based on the measurements of the best corrected visual acuity for distance and near vision, contrast sensitivity, microperimetry, 10-2 and 30-2 static perimetry, electroretinogram stimulated with the pattern (PERG) and multifocal electroretinogram (mfERG) in both eyes will be carried out at the time points T0, T1-T3. In addition, during the T0-T3 visits, the morphology of the eyeball, i.e. examination of the anterior segment and fundus of the eye in a slit lamp, examination of optical coherence tomography of the macula and ultrasound of the eyeball will be assessed. The quality of life of the participants of the experiment will be assessed on the basis of the standardized NEI VFQ-25 questionnaire. The quality of life assessment will take place both before the implementation of the SML and during subsequent follow-up visits. Expected project benefits Conducting the proposed experiment will result in verification of the effectiveness of the retinal stimulation by the yellow SML in comparison to the red SML in the eyes with retinitis pigmentosa. In addition, conducting genome analysis and monitoring changes in the concentration of pro-inflammatory, neurotrophic and angiogenic factors in the tear film and peripheral blood in combination with a detailed assessment of the dynamics of functional changes in the eyes with RP after stimulation with an immunomodulatory stimulus SML will enable optimization and personalization of this treatment method in relation to the genetic profile of the patient with RP. The expected results may direct further research on the search for an effective therapy for patients with RP or constitute the basis for the introduction of the world's first standard of adjuvant treatment in this disease entity.
NCT06787482
Summary of the Study This clinical trial evaluates a novel peptide-based therapy for treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy consists of peptides derived from fetal tissues, mesenchymal stem cells (MSCs), and bioactive growth factors, administered sublingually for systemic absorption. Study Objectives: Primary Objectives: Assess safety and tolerability, and evaluate the therapy's effects on retinal function and structure. Secondary Objectives: Explore improvements in visual acuity, retinal thickness, vascular health, and disease biomarkers. Study Design: Type: Open-label, single-arm interventional study. Duration: 12 months. Participants: 150 adults, divided into three cohorts: Retinal dystrophies. AMD (dry and wet forms). DR (moderate NPDR and PDR). Intervention: A sublingual solution containing peptides and growth factors, taken 4 times daily. Outcome Measures: Primary Outcomes: Safety (adverse events) and tolerability (treatment adherence). Secondary Outcomes: Functional: Visual acuity and field sensitivity improvements. Structural: Retinal thickness and vascular health. Biomarkers: Serum VEGF, oxidative stress, and inflammatory markers. Study Procedures: Monthly follow-ups for safety monitoring, vision tests, retinal imaging (OCT, FA), and blood biomarker analysis. Comprehensive evaluations at baseline, 6 months, and 12 months. Significance: The study aims to provide an innovative, non-invasive treatment for debilitating retinal conditions, potentially improving vision and retinal health through systemic therapy.
NCT04763369
Retinitis pigmentosa (RP) is the most common hereditary retinal disorder (accounts for 20% of children attending blind schools in Pakistan) which causes degeneration of rod and cone photoreceptors. Rods and cones largely depend on the retinal pigment epithelium for their proper functioning. Various growth factors and their receptors are present in retinal epithelium and a number of genes are responsible for the production of these growth factors. Genetic mutation in any of these genes causes retinal degeneration by progressive loss of retinal pigment epithelium and photoreceptors. The disease initially starts with night blindness and leads to the loss of central vision and eventually total blindness. To date, there is no definitive cure for patients suffering from RP. Recently, stem cell based therapies have shown great promise for the management of RP. It is well documented that umbilical cord derived mesenchymal stem cells (UMSCs) have the ability to release various paracrine and immunomodulatory factors that are similar to those synthesized by retinal pigment epithelium. Multiple routes including systemic (intravenous) and localized (subretinal, intravitreal, suprachoroidal and sub-tenon) have been employed to administer UMSCs for the management of RP. It is important to note that deep sub-tenon region (space between the sclera and the conjunctiva) acts as both natural culture medium for cells and as immune privileged site because of avascularity of the region. It has been reported that the injection of UMSCs in sub-tenon space of human subjects have improved the visual acuity even after 1 year post-injection. In addition, the injection of UMSCs in suprachoroidal space enhances the entry of growth factors released by the cells into choroidal flow and maintain the constant growth factors secretion to the choroidal and retinal tissues. Limoli and colleagues were the first to report the suprachoroidal administration of cells being the safe mode of cell delivery with no complications. The present study is aimed to investigate the safety and therapeutic efficacy of UMSC injection employing two different routes (sub-tenon injection versus suprachoroidal injection) for the treatment of RP in human subjects.
NCT01543906
The purpose of this study is: * To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in RP subjects with an autosomal dominant mutation in RPE65. * To evaluate duration of visual function improvement (if observed) in RP subjects with an autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001. * To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP subjects with an autosomal dominant mutation in RPE65.