A New Treatment of Retinitis Pigmentosa

June 25, 2019 updated by: Aier School of Ophthalmology, Central South University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongxia Wang, MD
  • Phone Number: 18302183233
  • Email: whxeye@163.com

Study Contact Backup

  • Name: Wensheng Li, MD,PHD
  • Phone Number: +8618650424985
  • Email: drlws@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the visual acuity
Time Frame: one day before injection, one day, one month, three months and six months after surgery
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
Time Frame: one day before injection, one month, three months and six months after surgery
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)
Time Frame: one day before injection, three months and six months after surgery
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)
Time Frame: one day before injection, three months and six months after surgery
To evaluate the retinal function with the use of electro-oculogram (EOG)
one day before injection, three months and six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier School of Ophthalmology, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHAIER2019IRB01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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