A New Treatment of Retinitis Pigmentosa

Not Applicable

• Conditions: Retinitis Pigmentosa
• Interventions: Procedure: retrobulbar injection of autoserum; Procedure: retrobulbar injection of placebo

• Registration Number: NCT03998384
• Lead Sponsor: Aier School of Ophthalmology, Central South University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-25
• Last Update Submitted: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Posted: 2019-06-26
• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of autoserum	retrobulbar injection of autoserum	One of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum.
group of placebo	retrobulbar injection of placebo	The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.

Primary Outcome Measures

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