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Dry Age-related Macular DegenerationPhase 1/2NCT03046407

Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells

A Phase 1/2 study testing retinal pigment epithelium transplantation in people with Dry Age-related Macular Degeneration, run by Chinese Academy of Sciences 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat dry AMD. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Dry Age-related Macular Degeneration
What is being tested?
retinal pigment epithelium transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
6 Sep 2017to Dec 2020
Phase
Phase 1/2
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 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 55-80 years;
  • Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS) (with one or more >250 micron geographic atrophy in the fovea;
  • No CNV;
  • The BCVA of target eye will not be better than 20/200;
  • -8.00D<diopter<+8.00D，21mm<axis oculi≤28mm;
  • voluntary as test subjects, signed informed consent, regular follow-up on time.

Who cannot join

  • The macular atrophy caused by other diseases in addition to AMD;
  • Suffer from retinitis pigmentosa, choroidal retinitis, central serous chorositis, diabetic retinopathy or other retinal vascular and degenerative diseases besides AMD;
  • Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy and other ocular history;
  • Other intraocular surgery history besides cataract surgery;
  • In the last 6 months, there were severe heart failure (New York Heart Association grade III and IV) or the left ventricular ejection fraction <35% in any examinations
  • One of the following circumstances: (1) dialysis or eGFR<20ml/min/1.73m2; (2) urinary protein / urinary creatinine is ≥1g/g; (3) creatinine or albumin / urinary creatinine is ≥600mg/g;
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  • Chronic liver disease, ALT increased >3 times normal value of the upper limit;
  • Combined with other serious systemic diseases, such as cor pulmonale, severe COPD (FEV1%<50%) and so on;
  • Combined with severe infectious diseases (such as HIV, syphilis antibody positive, etc;
  • The quantitative detection of HCV-RNA was positive, the quantitative detection of HBV-DNA was greater than 103 IU/ml, and tuberculosis was in the contagious period, etc;
  • Patients who are using anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days（The results of VerifyNow test show that AUC is greater than 470 and PRU is more than 208）;
  • Abnormal blood coagulation function or other obvious abnormal laboratory test results;
  • Malignant tumor and history of malignant tumor;
  • Women who are pregnant，prepare to be pregnant during the trial, be lactating；men who prepare to have baby during the trial;
  • Any immune deficiency;
  • Glucocorticoids or immunosuppressive drugs have been used in the last 3 months;
  • Antipsychotic drugs have been used in the last 3 months, such as antidepressants, antipsychotic drugs, and so on;
  • With hypersensitivity to tacrolimus or other macrolides;
  • The history of addiction to alcoholism or prohibited drugs;
  • Being participating in any intervention clinical trials;
  • Poor compliance, difficult to complete the study;
  • The person who did not receive the informed consent;
  • Some researchers believe that there may be situations that can increase risks of the subjects or interfere clinical trials (for example, patients are prone to mental stress, depression, mental disorders, cognitive dysfunction, etc.).

Trial locations and contacts

1 site in 1 country.

Wang Liu, Doctor contact

+86-01064807858

wangliu@ioz.ac.cn

Hao Jie, Doctor contact

+86-01062558737

haojie@ioz.ac.cn

China1 site, 1 recruiting

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan, 450052

    Wan guang ming, Doctor, 0371-66862213, wgm6608@163.com

    Li fu zhen, Doctor, 0371-66862213, fuzhenlii@qq.com

    Recruiting

Other trials in China

About this study

This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat dry AMD.

Read the detailed description

This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD). Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the safety and efficacy of RPE transplants to treat dry AMD.

Being tested
retinal pigment epithelium transplantation

What participants receive

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

  • retinal pigment epithelium transplantationBiological

    Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).

Study groups in NCT03046407
Study groupRoleWhat they receive
retinal pigment epithelium transplantationExperimentaltransplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
Receives: Biological: retinal pigment epithelium transplantation

What is being measured

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

  1. safety and tolerance of transplantation

    The safety and tolerance of transplantation of hESC-derived RPE will be considered safe: no above moderate adverse events or severe adverse events which related to transplantation of retinal pigment epithelial cells ; Cells without infectious; No tumorigenicity. Through the clinical signs of subjects and laboratory examination to judge the tolerance, integrity, repellency of RPE cells, and monitoring the presence of local or systemic infection, and presence of metastatic tumor cells.

    Measured: 12 months

Secondary outcomes (5)

  1. Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs)

    Visual function measure: change in visual acuity

    Measured: 12 months

  2. Efficacy：Best corrected visual acuity（BCVA）

    Visual function measure: change in visual acuity

    Measured: 12 months

  3. Efficacy：Optical coherent tomography (OCT)

    Visual function measure

    Measured: 12 months

  4. Efficacy：fundus autofluorescence

    Transplant and host retina integrity and survival

    Measured: 12 months

  5. Efficacy：vision inspection

    Changes of judgment after transplantation of patient's visual field

    Measured: 12 months

Timeline

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

  1. First posted8 Feb 2017 (estimated)
  2. Study start6 Sep 2017
  3. Primary completionJan 2019 (estimated)
  4. Study completionDec 2020 (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
Phase 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03046407
Sponsor's protocol ID
ChineseASZQ-004
Status last verified
Dec 2017
First submitted
2 Feb 2017
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing retinal pigment epithelium transplantation in people with Dry Age-related Macular Degeneration, run by Chinese Academy of Sciences 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 6 inclusion and 23 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 31 Jan 2018. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Wang Liu, Doctor (+86-01064807858, wangliu@ioz.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and tolerance of transplantation (time frame: 12 months). 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 NCT03046407.

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 31 Jan 2018.

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