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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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