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

June 4, 2015 updated by: Qianying Gao, Sun Yat-sen University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

404

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous Oxygen
Continuous oxygen intake and routine drug treatment .
Drug: Continuous oxygen
Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;
Drug: Compound thrombosis capsule sig: 1.5g/tid
Compound thrombosis capsule sig: 1.5g/tid
Drug: Ginkgo biloba pills sig: 300mg/tid;
Ginkgo biloba pills sig: 300mg/tid;
Drug: Vitamin B sig: 10mg/tid
Vitamin B sig: 10mg/tid
Drug: Vitamin AD sig: 1 tablet/tid
Vitamin AD sig: 1 tablet/tid
Experimental: Blue Light Deprivation
Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
Drug: Compound thrombosis capsule sig: 1.5g/tid
Compound thrombosis capsule sig: 1.5g/tid
Drug: Ginkgo biloba pills sig: 300mg/tid;
Ginkgo biloba pills sig: 300mg/tid;
Drug: Vitamin B sig: 10mg/tid
Vitamin B sig: 10mg/tid
Drug: Vitamin AD sig: 1 tablet/tid
Vitamin AD sig: 1 tablet/tid
Device: blue light-absorbing sunglasses
Wearing blue light-absorbing sunglasses at daily time;
Experimental: Continuous Oxygen Therapy Combined With Blue Light Deprivation
Continuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
Drug: Continuous oxygen
Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;
Drug: Compound thrombosis capsule sig: 1.5g/tid
Compound thrombosis capsule sig: 1.5g/tid
Drug: Ginkgo biloba pills sig: 300mg/tid;
Ginkgo biloba pills sig: 300mg/tid;
Drug: Vitamin B sig: 10mg/tid
Vitamin B sig: 10mg/tid
Drug: Vitamin AD sig: 1 tablet/tid
Vitamin AD sig: 1 tablet/tid
Device: blue light-absorbing sunglasses
Wearing blue light-absorbing sunglasses at daily time;
Other: control
Routine drug treatment
Drug: Compound thrombosis capsule sig: 1.5g/tid
Compound thrombosis capsule sig: 1.5g/tid
Drug: Ginkgo biloba pills sig: 300mg/tid;
Ginkgo biloba pills sig: 300mg/tid;
Drug: Vitamin B sig: 10mg/tid
Vitamin B sig: 10mg/tid
Drug: Vitamin AD sig: 1 tablet/tid
Vitamin AD sig: 1 tablet/tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up.
Time Frame: at 5 years follow-up
at 5 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ERG b-wave mean values
Time Frame: at 5 years follow-up
at 5 years follow-up
Change of visual field
Time Frame: at 5 years follow-up
visual field
at 5 years follow-up
Fundus changes of fluorescence fundus angiography
Time Frame: at 5 years follow-up
at 5 years follow-up
Retinal vessel oxygen saturation
Time Frame: at 5 years follow-up
Retinal Oximetry
at 5 years follow-up
intra-ocular pressure
Time Frame: at 1, 2, 3, 4 and 5 years follow-up
at 1, 2, 3, 4 and 5 years follow-up
blood pressure
Time Frame: at 1, 2, 3, 4 and 5 years follow-up
at 1, 2, 3, 4 and 5 years follow-up
Finger pulse oxygen saturation
Time Frame: at 1, 2, 3, 4 and 5 years follow-up
Finger pulse oximetry
at 1, 2, 3, 4 and 5 years follow-up
the mutant genes of retinitis pigmentosa
Time Frame: at admission
gene screening
at admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOC20150503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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