A New Treatment of Retinitis Pigmentosa
Retrobulbar Injection of Autoserum in the Treatment of Retinitis Pigmentosa: A Prospective, Non-randomized Interventional Study
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 26, 2019
June 1, 2019
3 years
June 7, 2019
June 25, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
group of autoserum
ACTIVE COMPARATOROne of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum.
group of placebo
PLACEBO COMPARATORThe other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of retinitis pigmentosa
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2019
First Posted
June 26, 2019
Study Start
January 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
June 26, 2019
Record last verified: 2019-06