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Retinitis PigmentosaEarly Phase 1NCT02465749

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

A Early Phase 1 study testing Continuous oxygen, blue light-absorbing sunglasses and Compound thrombosis capsule sig: 1.5g/tid in people with Retinitis Pigmentosa, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Retinitis Pigmentosa
What is being tested?
Continuous oxygen, blue light-absorbing sunglasses and Compound thrombosis capsule sig: 1.5g/tid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
1 siteChina
Study dates
May 2015to Jun 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Qianying Gao, PHD contact

13751829105/18922103820

gaoqy@mail.sysu.edu.cn

China1 site

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

    Guangzhou, Guangdong, 510060

    Qianying Qao, PHD, 13751829105/18922103820, gaoqy@mail.sysu.edu.cn

Other trials in China

About this study

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.

Read the 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.

Being tested
Continuous oxygen, blue light-absorbing sunglasses, Compound thrombosis capsule sig: 1.5g/tid, Ginkgo biloba pills sig: 300mg/tid;, Vitamin B sig: 10mg/tid
Keywords
Retinitis Pigmentosa, oxygen, blue light
Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous oxygenDrug

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

  • blue light-absorbing sunglassesDevice

    Wearing blue light-absorbing sunglasses at daily time;

  • Compound thrombosis capsule sig: 1.5g/tidDrug

    Compound thrombosis capsule sig: 1.5g/tid

  • Ginkgo biloba pills sig: 300mg/tid;Drug

    Ginkgo biloba pills sig: 300mg/tid;

  • Vitamin B sig: 10mg/tidDrug

    Vitamin B sig: 10mg/tid

  • Vitamin AD sig: 1 tablet/tidDrug

    Vitamin AD sig: 1 tablet/tid

Study groups in NCT02465749
Study groupRoleWhat they receive
Continuous OxygenExperimentalContinuous oxygen intake and routine drug treatment .
Receives: Drug: Continuous oxygen; 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
Blue Light DeprivationExperimentalWearing blue light-absorbing sunglasses at daily time and routine drug treatment
Receives: 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
Continuous Oxygen Therapy Combined With Blue Light DeprivationExperimentalContinuous oxygen intake , Wearing blue light-absorbing sunglasses at daily time and routine drug treatment
Receives: 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
controlOtherRoutine drug treatment
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at 5 years follow-up

Secondary outcomes (8)

  1. ERG b-wave mean values

    Measured: at 5 years follow-up

  2. Change of visual field

    visual field

    Measured: at 5 years follow-up

  3. Fundus changes of fluorescence fundus angiography

    Measured: at 5 years follow-up

  4. Retinal vessel oxygen saturation

    Retinal Oximetry

    Measured: at 5 years follow-up

  5. intra-ocular pressure

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

  6. blood pressure

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

  7. Finger pulse oxygen saturation

    Finger pulse oximetry

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

  8. the mutant genes of retinitis pigmentosa

    gene screening

    Measured: at admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465749
Sponsor's protocol ID
ZOC20150503
Status last verified
Jun 2015
First submitted
22 May 2015
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Continuous oxygen, blue light-absorbing sunglasses and Compound thrombosis capsule sig: 1.5g/tid in people with Retinitis Pigmentosa, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qianying Gao, PHD (13751829105/18922103820, gaoqy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the percentage of patients preserved 80% of the initial visual acuity at 5 years follow-up. (time frame: at 5 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02465749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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