Retinitis PigmentosaNCT03998384
A New Treatment of Retinitis Pigmentosa
A study testing retrobulbar injection of autoserum in people with Retinitis Pigmentosa, run by Aier School of Ophthalmology, Central South University.
Trial summary
This study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- retrobulbar injection of autoserum
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of retinitis pigmentosa
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- retrobulbar injection of autoserum, retrobulbar injection of placebo
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrobulbar injection of autoserumProcedure or surgery
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 injection of placeboProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| group of autoserum | Active comparator | One of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum. Receives: Procedure: retrobulbar injection of autoserum |
| group of placebo | Placebo comparator | The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution. Receives: Procedure: retrobulbar injection of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the visual acuity
To measure the visual acuity with logarithmic visual chart.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: one day before injection, three months and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998384
- Sponsor's protocol ID
- SHAIER2019IRB01
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrobulbar Injection of Autoserum in the Treatment of Retinitis Pigmentosa: A Prospective, Non-randomized Interventional Study
- ClinicalTrials.gov ID
- NCT03998384
- Acronym / sponsor ID
- SHAIER2019IRB01
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group of autoserum | Active comparator | Procedure: retrobulbar injection of autoserumOne 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 comparator | Procedure: retrobulbar injection of placeboThe other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of retinitis pigmentosa
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrobulbar injection of autoserumRetrobulbar 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. | Procedure or surgery | group of autoserum |
| retrobulbar injection of placeboRetrobulbar 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 | Procedure or surgery | group of placebo |
Primary outcome
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.
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.
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).
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing retrobulbar injection of autoserum in people with Retinitis Pigmentosa, run by Aier School of Ophthalmology, Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongxia Wang, MD (18302183233, whxeye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the visual acuity (time frame: one day before injection, one day, one month, three months and six months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.