A New Treatment of Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

Official title:

Retrobulbar Injection of Autoserum in the Treatment of Retinitis Pigmentosa: A Prospective, Non-randomized Interventional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03998384
• Other study ID #: SHAIER2019IRB01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2019
• Source: Aier School of Ophthalmology, Central South University
• Contact: Hongxia Wang, MD
• Phone: 18302183233
• Email: whxeye[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

Description:

The retinitis pigmentosa(RP) is an hereditary disease which causes visual deficiency leading to blindness. The methods of treatment include gene therapy, stem cell therapy and visual prothesis, etc. But all these methods own limitations can not be conquered in a short period. It was proved that vascular endothelial growth factor (VEGF) and pigment epithelium derived factor (PEDF) decreased in the aqueous humor of patients of RP. But the traditional exogenous nerve growth factors (NGFs) were immunogenic proteins and may cause inflammation. Autoserum contain a large amount of active factors and will not cause exclusive reaction. In this study we aim to assess and to evaluate the therapeutic effect and the safety of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of retinitis pigmentosa

Exclusion Criteria:

• Suspected glaucoma, suspected optic nerve disease, blindness due to other ocular disease

• Combined with serious systemic disease

• Can not cooperate with the interventions and examinations.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Procedure:
• retrobulbar injection of autoserum
Retrobulbar block is usually a type of regional anesthetic nerve block used in intraocular surgery. In this technique, local autoserum is injected into the retrobulbar space for the neurotrophic purpose.
• retrobulbar injection of placebo
Retrobulbar block is usually a type of regional anesthetic nerve block used in intraocular surgery. In this technique, normal saline (NS) is injected into the retrobulbar space as a comparison

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the visual acuity	To measure the visual acuity with logarithmic visual chart.	one day before injection, one day, one month, three months and six months after surgery
Primary	Change of the contrast sensitivity	To access the change of contrast sensitivity in different special frequency.	one day before injection, one month, three months and six months after surgery
Primary	Change of the electrophysiological detection (flash electroretinogram)	To evaluate the retinal function with the use of flash electroretinogram (F-ERG).	one day before injection, three months and six months after surgery
Primary	Change of the electrophysiological detection (electro-oculogram)	To evaluate the retinal function with the use of electro-oculogram (EOG)	one day before injection, three months and six months after surgery