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Trial record 6 of 140 for:    "Retinitis pigmentosa"

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

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ClinicalTrials.gov Identifier: NCT02465749
Recruitment Status : Not yet recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Jeeyor Medical Research Co.,Ltd.
Information provided by (Responsible Party):
Qianying Gao, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: Continuous oxygen Device: blue light-absorbing sunglasses Drug: Compound thrombosis capsule sig: 1.5g/tid Drug: Ginkgo biloba pills sig: 300mg/tid; Drug: Vitamin B sig: 10mg/tid Drug: Vitamin AD sig: 1 tablet/tid Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa
Study Start Date : May 2015
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025


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
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

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: 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;

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

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

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




Primary Outcome Measures :
  1. 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 Measures :
  1. ERG b-wave mean values [ Time Frame: at 5 years follow-up ]
  2. Change of visual field [ Time Frame: at 5 years follow-up ]
    visual field

  3. Fundus changes of fluorescence fundus angiography [ Time Frame: at 5 years follow-up ]
  4. Retinal vessel oxygen saturation [ Time Frame: at 5 years follow-up ]
    Retinal Oximetry

  5. intra-ocular pressure [ Time Frame: at 1, 2, 3, 4 and 5 years follow-up ]
  6. blood pressure [ Time Frame: at 1, 2, 3, 4 and 5 years follow-up ]
  7. Finger pulse oxygen saturation [ Time Frame: at 1, 2, 3, 4 and 5 years follow-up ]
    Finger pulse oximetry

  8. the mutant genes of retinitis pigmentosa [ Time Frame: at admission ]
    gene screening



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465749


Contacts
Contact: Qianying Gao, PHD 13751829105/18922103820 gaoqy@mail.sysu.edu.cn

Locations
China, Guangdong
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Qianying Qao, PHD    13751829105/18922103820    gaoqy@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Jeeyor Medical Research Co.,Ltd.
Investigators
Principal Investigator: Qianying Gao, PHD State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Qianying Gao, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02465749     History of Changes
Other Study ID Numbers: ZOC20150503
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Qianying Gao, Sun Yat-sen University:
Retinitis Pigmentosa
oxygen
blue light

Additional relevant MeSH terms:
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinitis
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs