A New Treatment of Retinitis Pigmentosa

Aier School of Ophthalmology, Central South University

Status: Unknown

Conditions: Retinitis Pigmentosa

Treatments: Procedure: retrobulbar injection of autoserum; Procedure: retrobulbar injection of placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03998384

SHAIER2019IRB01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

group of autoserum

Active Comparator group

Description:

One of two eyes of one patient which is assessed to have more serious retinal atrophy will receive the retrobulbar injection of autoserum.

Treatment:

Procedure: retrobulbar injection of autoserum

group of placebo

Placebo Comparator group

Description:

The other eye which is assessed to have milder retinal atrophy will receive the retrobulbar injection of saline solution.

Treatment:

Procedure: retrobulbar injection of placebo