A New Treatment of Retinitis Pigmentosa

Sponsor

Aier School of Ophthalmology, Central South University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03998384

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa	Procedure: retrobulbar injection of autoserum Procedure: retrobulbar injection of placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group 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.	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.
Placebo Comparator: group of placebo The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: group 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.

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.

Placebo Comparator: group of placebo

The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.

Procedure: 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

Outcome Measures

Primary Outcome Measures

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 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).
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Aier School of Ophthalmology, Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aier School of Ophthalmology, Central South University

ClinicalTrials.gov Identifier:

NCT03998384

Other Study ID Numbers:

SHAIER2019IRB01

First Posted:

Jun 26, 2019

Last Update Posted:

Jun 26, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinitis

Retinitis Pigmentosa

Study Results

No Results Posted as of Jun 26, 2019