NCT07085533 Natural History Study of Inherited Retinal Diseases
| NCT ID | NCT07085533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongmou Therapeutics |
| Condition | Retinal Dystrophies |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-20 |
| Primary Completion | 2027-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-07-20 with a primary completion date of 2027-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, observational investigation seeks to delineate the interplay between chromatic vision deficits and both functional visual outcomes and anatomical retinal biomarkers in individuals affected by Inherited Retinal Dystrophies (IRDs). The study will recruit approximately 200 subjects, encompassing a heterogeneous population of IRD patients-spanning a range of genotypes and clinical severities-as well as control participants devoid of retinal pathology. All enrolled individuals will undergo a standardized battery of evaluations, including quantitative color vision assessment, best-corrected visual acuity (BCVA) determination, and advanced multimodal retinal imaging. The principal aim is to characterize the relationship between impairments in color discrimination and morphologic disruptions within the outer retinal layers, with particular emphasis on the continuity and reflectivity of the ellipsoid zone (EZ)-historically referred to as the inner segment/outer segment (IS/OS) junction-assessed through spectral-domain optical coherence tomography (SD-OCT). Further, the study will explore associations between chromatic perceptual deficits and underlying genetic mutations, mutation patterns specific to IRD subtypes, and the influence of patient age on the severity and progression of color vision loss. A key secondary objective is the clinical appraisal and validation of a novel diagnostic modality, the Moji Low-Vision Color Discrimination Test (Moji Test), which is specifically engineered to quantify residual color perception in individuals with advanced central visual impairment. The test's discriminatory capacity will be benchmarked against established color vision testing paradigms to assess its reliability, clinical sensitivity, and suitability for implementation in populations with severe visual acuity reduction. By incorporating a genetically and phenotypically diverse IRD cohort, the study is designed to enable granular, stratified analyses that will refine the understanding of structural-functional correlations in hereditary retinal disease. The inclusion of a control group with preserved retinal architecture and normal color vision function will provide essential normative baselines for comparative evaluation and statistical inference.
Eligibility Criteria
Inclusion Criteria: 1. Color Perception and Communication Ability Participants must have the ability to verbally identify or describe colors and test stimuli. This requires adequate cognitive and communicative capacity to understand instructions and respond appropriately during color vision testing. 2. Diagnosis of Inherited Retinal Dystrophy (IRD Group Only) Participants assigned to the IRD group must have a confirmed clinical diagnosis of an inherited retinal dystrophy 3. No Evidence of Inherited Retinal Disease (Control Group Only) Participants in the control group must have: * No known history or clinical evidence of inherited retinal degeneration * Normal retinal health or only non-retinal ocular conditions not affecting retinal function (e.g., mild cataract, corrected refractive error) * Normal or expected-normal color vision Exclusion Criteria: 1. Non retinal causes of color vision loss * Optic neuropathies (e.g., optic neuritis, glaucoma related optic nerve damage) * Cortical vision impairments affecting color perception * Any other neurological or optic nerve pathology causing color vision deficiency 2. Psychological or cognitive conditions affecting color perception or communication * Severe developmental delays * Cognitive impairments interfering with ability to comprehend or reliably perform color vision tests * Psychiatric conditions that impair visual interpretation or reliable testing 3. Prior treatment with potential transient effects on the retina * Recent retinal surgery * Recent drug therapy affecting retinal structure or function * Any acute intervention that might confound the correlation analyses due to lack of a stable baseline
Contact & Investigator
Yin Shen
PRINCIPAL INVESTIGATOR
Renmin Hospital of Wuhan University
Frequently Asked Questions
Who can join the NCT07085533 clinical trial?
This trial is open to participants of all sexes, studying Retinal Dystrophies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07085533 currently recruiting?
Yes, NCT07085533 is actively recruiting participants. Contact the research team at mojtaba98shirinzadeh@gmail.com for enrollment information.
Where is the NCT07085533 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07085533 clinical trial?
NCT07085533 is sponsored by Zhongmou Therapeutics. The principal investigator is Yin Shen at Renmin Hospital of Wuhan University. The trial plans to enroll 200 participants.