Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

Official title:

Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02465749
• Other study ID #: ZOC20150503
• Status: Not yet recruiting
• Phase: Phase 0
• First received: May 22, 2015
• Last updated: June 4, 2015
• Start date: May 2015
• Est. completion date: June 2025

Study information

• Verified date: June 2015
• Source: Sun Yat-sen University
• Contact: Qianying Gao, PHD
• Phone: 13751829105/18922103820
• Email: gaoqy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the role of continuous oxygen therapy combined with blue light deprivation in prevention and control of retinitis pigmentosa, in order to find a new strategy of treatment for retinitis pigmentosa.

Description:

Retinitis pigmentosa (RP) is one of of the major causes of blindness in ocular diseases.Up to now, the etiology of RP remained unclear, and there are no effective therapeutic methods. Several studies had showed that the retina of RP may be anoxic, and oxygen therapy, such as hyperbaric oxygen (hyperbaric oxygen, HBO) treatment, had shown a definite effect on RP. The investigators' previous researches also found that the retinal vessel oxygen saturation in patients with RP who were older than 40 years were significantly lower than normal controls, suggesting that oxygen may play an important role in the development of RP. Besides, many studies have revealed that blue light could damage retina pigment epithelium cells and photoreceptor cell specially. Therefore, investigators will combine continuous oxygen therapy and blue light deprivation therapy in the treatment for RP in this study, in order to find a new strategy of treatment for RP.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 404
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Severe patients with RP who meet the following criteria: (1) the EDTRS visual acuity of the good eye < 0.3 (low vision);(2) the radius of central visual field< 10 °(low vision)

2. Age range from 18 to 60 years old, sex unlimited

3. Able to adhere to treatment for more than 12 months

4. Willing to participate in this trial, and sign the informed consent

Exclusion Criteria:

1. Serious opacity of cornea, lens or vitreous body which can't have clear fundus examination

2. Patients with severe systemic diseases who was unable to tolerate the examinations, such as heart failure, respiratory failure, sepsis, severe anemia, kidney disease, history of eye surgery and so on

3. Patients who was unable to tolerate oxygen treatment, such as severe pulmonary edema, deformity of the respiratory tract, respiratory tract infection, tuberculosis, patients with pregnancy, and so on

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Drug:
• Continuous oxygen
Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;

Device:
• blue light-absorbing sunglasses
Wearing blue light-absorbing sunglasses at daily time;

Drug:
• Compound thrombosis capsule sig: 1.5g/tid
Compound thrombosis capsule sig: 1.5g/tid
• Ginkgo biloba pills sig: 300mg/tid;
Ginkgo biloba pills sig: 300mg/tid;
• Vitamin B sig: 10mg/tid
Vitamin B sig: 10mg/tid
• Vitamin AD sig: 1 tablet/tid
Vitamin AD sig: 1 tablet/tid

Locations

Country	Name	City	State
China	State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou Jeeyor Medical Research Co.,Ltd., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.		at 5 years follow-up	No
Secondary	ERG b-wave mean values		at 5 years follow-up	No
Secondary	Change of visual field	visual field	at 5 years follow-up	No
Secondary	Fundus changes of fluorescence fundus angiography		at 5 years follow-up	No
Secondary	Retinal vessel oxygen saturation	Retinal Oximetry	at 5 years follow-up	No
Secondary	intra-ocular pressure		at 1, 2, 3, 4 and 5 years follow-up	Yes
Secondary	blood pressure		at 1, 2, 3, 4 and 5 years follow-up	Yes
Secondary	Finger pulse oxygen saturation	Finger pulse oximetry	at 1, 2, 3, 4 and 5 years follow-up	Yes
Secondary	the mutant genes of retinitis pigmentosa	gene screening	at admission	No