A New Treatment of Retinitis Pigmentosa
Primary Purpose
Retinitis Pigmentosa
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retrobulbar injection of autoserum
retrobulbar injection of placebo
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
group of autoserum
group of placebo
Arm Description
One of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum.
The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.
Outcomes
Primary Outcome Measures
Change of the visual acuity
To measure the visual acuity with logarithmic visual chart.
Change of the contrast sensitivity
To access the change of contrast sensitivity in different special frequency.
Change of the electrophysiological detection (flash electroretinogram)
To evaluate the retinal function with the use of flash electroretinogram (F-ERG).
Change of the electrophysiological detection (electro-oculogram)
To evaluate the retinal function with the use of electro-oculogram (EOG)
Secondary Outcome Measures
Full Information
NCT ID
NCT03998384
First Posted
June 7, 2019
Last Updated
June 25, 2019
Sponsor
Aier School of Ophthalmology, Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03998384
Brief Title
A New Treatment of Retinitis Pigmentosa
Official Title
Retrobulbar Injection of Autoserum in the Treatment of Retinitis Pigmentosa: A Prospective, Non-randomized Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aier School of Ophthalmology, Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group of autoserum
Arm Type
Active Comparator
Arm Description
One of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum.
Arm Title
group of placebo
Arm Type
Placebo Comparator
Arm Description
The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.
Intervention Type
Procedure
Intervention Name(s)
retrobulbar injection of autoserum
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
retrobulbar injection of placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of the visual acuity
Description
To measure the visual acuity with logarithmic visual chart.
Time Frame
one day before injection, one day, one month, three months and six months after surgery
Title
Change of the contrast sensitivity
Description
To access the change of contrast sensitivity in different special frequency.
Time Frame
one day before injection, one month, three months and six months after surgery
Title
Change of the electrophysiological detection (flash electroretinogram)
Description
To evaluate the retinal function with the use of flash electroretinogram (F-ERG).
Time Frame
one day before injection, three months and six months after surgery
Title
Change of the electrophysiological detection (electro-oculogram)
Description
To evaluate the retinal function with the use of electro-oculogram (EOG)
Time Frame
one day before injection, three months and six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxia Wang, MD
Phone
18302183233
Email
whxeye@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wensheng Li, MD,PHD
Phone
+8618650424985
Email
drlws@qq.com
12. IPD Sharing Statement
Learn more about this trial
A New Treatment of Retinitis Pigmentosa
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