Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies

Inherited Retinal Dystrophies Clinical Trial

— RID  

Official title:

Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03691168
• Other study ID #: Shanghai1stSXD
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: May 30, 2023

Study information

• Verified date: September 2018
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: huixun Jia, Master
• Phone: +86 18017317575
• Email: jiahuixun[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Based on a clinical multi-center study of the natural course of inherited retinal dystrophies in Chinese population, screening fundus imaging indicators for patients with Chinese inherited retinal dystrophies, describing the clinical features of Chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - Follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in China. The research will further improve and enrich the genotype, phenotypic characteristics and natural course of Chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. It is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with IRDs whose mutations have been identified

2. 4~70 years old

3. Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG

Exclusion Criteria:

1. Has participated in other interventional treatment studies;

2. Patients with severe systemic diseases, mental dysplasia, mental illness;

3. Unable to accept eye examination patients;

4. Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis

5. At the initial visit, the patient's binocular vision is displayed as no light.

6. Both eyes have a history of internal eye surgery

Related Conditions & MeSH terms

• Inherited Retinal Dystrophies
• Retinal Dystrophies

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	A typical Snellen chart that if frequently used for visual acuity testing	60 months