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

Primary Purpose

Retinitis Pigmentosa

Status

Not yet recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Continuous oxygen

blue light-absorbing sunglasses

Compound thrombosis capsule sig: 1.5g/tid

Ginkgo biloba pills sig: 300mg/tid;

Vitamin B sig: 10mg/tid

Vitamin AD sig: 1 tablet/tid

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, oxygen, blue light

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
Age range from 18 to 60 years old, sex unlimited
Able to adhere to treatment for more than 12 months
Willing to participate in this trial, and sign the informed consent

Exclusion Criteria:

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

Sites / Locations

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Arm Label

Continuous Oxygen

Blue Light Deprivation

Continuous Oxygen Therapy Combined With Blue Light Deprivation

control

Arm Description

Continuous oxygen intake and routine drug treatment .

Wearing blue light-absorbing sunglasses at daily time and routine drug treatment

Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment

Routine drug treatment

Outcomes

Primary Outcome Measures

the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.

Secondary Outcome Measures

ERG b-wave mean values

Change of visual field

visual field

Fundus changes of fluorescence fundus angiography

Retinal vessel oxygen saturation

Retinal Oximetry

intra-ocular pressure

blood pressure

Finger pulse oxygen saturation

Finger pulse oximetry

the mutant genes of retinitis pigmentosa

gene screening

Full Information

NCT ID

NCT02465749

First Posted

May 22, 2015

Last Updated

June 4, 2015

Sponsor

Sun Yat-sen University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02465749

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2015 (undefined)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

Keywords

Retinitis Pigmentosa, oxygen, blue light

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

404 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous Oxygen

Arm Type

Experimental

Arm Description

Continuous oxygen intake and routine drug treatment .

Arm Title

Blue Light Deprivation

Arm Type

Experimental

Arm Description

Wearing blue light-absorbing sunglasses at daily time and routine drug treatment

Arm Title

Continuous Oxygen Therapy Combined With Blue Light Deprivation

Arm Type

Experimental

Arm Description

Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment

Arm Title

control

Arm Type

Other

Arm Description

Routine drug treatment

Intervention Type

Drug

Intervention Name(s)

Continuous oxygen

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

blue light-absorbing sunglasses

Intervention Description

Wearing blue light-absorbing sunglasses at daily time;

Intervention Type

Drug

Intervention Name(s)

Compound thrombosis capsule sig: 1.5g/tid

Intervention Description

Compound thrombosis capsule sig: 1.5g/tid

Intervention Type

Drug

Intervention Name(s)

Ginkgo biloba pills sig: 300mg/tid;

Intervention Description

Ginkgo biloba pills sig: 300mg/tid;

Intervention Type

Drug

Intervention Name(s)

Vitamin B sig: 10mg/tid

Intervention Description

Vitamin B sig: 10mg/tid

Intervention Type

Drug

Intervention Name(s)

Vitamin AD sig: 1 tablet/tid

Intervention Description

Vitamin AD sig: 1 tablet/tid

Primary Outcome Measure Information:

Title

the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.

Time Frame

at 5 years follow-up

Secondary Outcome Measure Information:

Title

ERG b-wave mean values

Time Frame

at 5 years follow-up

Title

Change of visual field

Description

visual field

Time Frame

at 5 years follow-up

Title

Fundus changes of fluorescence fundus angiography

Time Frame

at 5 years follow-up

Title

Retinal vessel oxygen saturation

Description

Retinal Oximetry

Time Frame

at 5 years follow-up

Title

intra-ocular pressure

Time Frame

at 1, 2, 3, 4 and 5 years follow-up

Title

blood pressure

Time Frame

at 1, 2, 3, 4 and 5 years follow-up

Title

Finger pulse oxygen saturation

Description

Finger pulse oximetry

Time Frame

at 1, 2, 3, 4 and 5 years follow-up

Title

the mutant genes of retinitis pigmentosa

Description

gene screening

Time Frame

at admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Age range from 18 to 60 years old, sex unlimited Able to adhere to treatment for more than 12 months Willing to participate in this trial, and sign the informed consent Exclusion Criteria: Serious opacity of cornea, lens or vitreous body which can't have clear fundus examination 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qianying Gao, PHD

Phone

13751829105/18922103820

gaoqy@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qianying Gao, PHD

Organizational Affiliation

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qianying Qao, PHD

Phone

13751829105/18922103820

gaoqy@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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