A New Treatment of Retinitis Pigmentosa

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Procedure: retrobulbar injection of autoserum
* Procedure: retrobulbar injection of placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two eyes of one patient with RP will be divided into two groups. One eye with more serious retinal atrophy will receive retrobulbar injection of autoserum, and the other eye will receive retrobulbar injection of saline solution.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group of autoserum<br>One of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum. | Procedure: retrobulbar injection of autoserum<br>* 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.<br>|
| Placebo Comparator: group of placebo<br>The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution. | Procedure: retrobulbar injection of placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |