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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
Aier School of Ophthalmology, Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

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

    First Posted
    June 7, 2019
    Last Updated
    June 25, 2019
    Sponsor
    Aier School of Ophthalmology, Central South University
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    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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