Safety and Efficacy Evaluation of Intravitreal Injection of GMP-compliant Bone Marrow Mesenchymal Stem Cell-derived Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
The aim of this clinical trials is to evaluate the safety and efficacy of intravitreal injection of GMP-compliant BM-MSC-derived sEVs in patients with retinitis pigmentosa.
NCT06242379 — Retinitis Pigmentosa
Status: Recruiting
http://inclinicaltrials.com/retinitis-pigmentosa/NCT06242379/
A Pilot, Randomised, Masked Study to Investigate the Effect of Coloured-light on Colour Contrast Thresholds in Retinitis Pigmentosa.
This study will assess the effect of 2 different colours of light on colour vision in adults with retinitis pigments (RP). Participants will be 18 years or above with a genetically confirmed molecular diagnosis of RP. After informed consent, participants will have their letter chart vision and colour vision measured in their study eye. They will then be they will be randomly allocated to one of 2 groups. The study team will not know which group they have been assigned to. Group 1 will be given a coloured-light hand-held torch and be asked to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. Group 2 will be given a different colour hand-held torch and be asked to do the same. All participants will have their letter chart vision and colour vision measured at the end of study on day 28 (+ 7 days).
NCT06224114 — Retinitis Pigmentosa
Status: Not yet recruiting
http://inclinicaltrials.com/retinitis-pigmentosa/NCT06224114/
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
NCT05909488 — Retinitis Pigmentosa
Status: Recruiting
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05909488/
An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraocular Administration of FT-002 in Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa.
A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).
NCT05874310 — X-Linked Retinitis Pigmentosa
Status: Recruiting
http://inclinicaltrials.com/x-linked-retinitis-pigmentosa/NCT05874310/
Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (QUANTUM): a Pilot, Randomized, Double-masked, Sham-controlled, Clinical Device Trial
Pilot, randomized, observer and participant masked, sham and fellow eye controlled, interventional clinical device trail to evaluate the safety and effectiveness of the 2C-QD device to improve visual function in adults with advanced Retinitis Pigmentosa (RP).
NCT05841862 — Retinitis Pigmentosa
Status: Not yet recruiting
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05841862/
Natural History Study in Retinitis Pigmentosa Caused by Mutations in the BEST1 Gene
The purpose of this study is to establish the natural history of of participants with BESTROPHIN 1 Vitelliform Macular Dystrophy. The blinding disorder Best Vitelliform Macular Dystrophy (VMD) is caused by any one of more than 250 different mutations in the BEST1 gene. As new treatments are developed, a clear understanding of the natural history of disease progression of BEST1 VMD is necessary. The goals of this natural history study are to: 1. Report the natural history of retinal degeneration in participants with a clinical diagnosis of VMD with molecular confirmation of a pathogenic BEST1 mutation(s). 2. Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials for the treatment of BESTROPHIN 1 VMD. 3. Compare progression of the identified structural and functional measures between the two eyes to judge the suitability of the second untreated eye as a control for a future clinical trial involving unilateral treatment 4. Identify well-defined patient populations for future clinical trials of investigative treatments for BEST1 VMD.
NCT05809635 — Retinitis Pigmentosa
Status: Recruiting
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05809635/
A Single-arm, Open-label Exploratory Clinical Study to Assess the Preliminary Safety of the Gene Editing Drug ZVS203e for the Management of Retinitis Pigmentosa Caused by Mutations in the RHO Gene
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single escalating doses of ZVS203e administered via subretinal injection in participants with RP caused by RHO site-specific gene mutation (RHO-RP).
NCT05805007 — Retinitis Pigmentosa
Status: Recruiting
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05805007/
Bioretina, Ankara University Technopolis
Purpose To investigate whether the natural progression rate of retinitis pigmentosa (RP) can be decreased with subtenon umbilical cord Wharton's jelly derived mesenchymal stemcell (WJ-MSC) application alone or combination with retinal electromagnetic stimulation (rEMS). Material and methods The study included prospective analysis of 130 eyes of 80 retinitis pigmentosa patients with a 36-month follow-up duration. Patients constitute 4 groups with similar demographic characteristics. The subtenon WJ-MSC only group consisted of 34 eyes of 32 RP patients as Group1; The rEMS only group consisted of 32 eyes of 16 RP patients as Group2; The combined management group consisted of 32 eyes of 16 RP patients who received combined WJ-MSC and rEMS as Group3; The natural course (control) group consisted of 32 eyes of 16 RP patients who did not receive any treatment were classified as Group4. Fundus autofluorescence surface area (FAF-field), horizontal and vertical ellipsoid zone width (EZW), fundus perimetry deviation index (FPDI), full field electroretinography magnitude (ERG-m) and best corrected visual acuity (BCVA) changes were compared within and between groups after 36 month follow up period.
NCT05800301 — Retinitis Pigmentosa
Status: Completed
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05800301/
Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa
The study will perform to follow-up UC-MSCs and CM transplantation. 18 patients will be called back to be examined after 5 years of UC-MSC and/or CM transplantation.
NCT05786287 — Retinitis Pigmentosa
Status: Enrolling by invitation
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05786287/
Suprachoroidal Spheroidal Mesenchymal Stem Cell Implantation in Retinitis Pigmentosa: Clinical Results of 6 Months Follow-up
Purpose: This prospective clinical case series aimed to evaluate the effect of suprachoroidal implantation of mesenchymal stem cells (MSCs) in the form of spheroids as a stem cell therapy for retinitis pigmentosa (RP) patients with relatively good visual acuity. Methods: Fifteen eyes of 15 patients with RP who received suprachoroidal implantation of MSCs in the form of spheroids were included. Best corrected visual acuity (BCVA), 10-2 and 30-2 visual field examination and multifocal electroretinography (mfERG) recordings were recorded at baseline, postoperative first, third- and sixth-months during follow-up.
NCT05712148 — Retinitis Pigmentosa
Status: Completed
http://inclinicaltrials.com/retinitis-pigmentosa/NCT05712148/