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Age-Related Macular DegenerationPhase 1NCT02452385

Phase 1 Study of CM082 in Patients With wAMD

A Phase 1 study testing CM082 tablet in people with Age-Related Macular Degeneration, run by AnewPharma at 6 sites in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
CM082 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
6 sitesChina
Study dates
Mar 2015to Jun 2020
Phase
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT.
  • Patients with either no previous anti-VEGF therapy or prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment.
  • Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA 20/40 to 20/320 in the study eye(s).
  • Adequate bone marrow, hepatic, and renal functions.
  • Willing and able to provide written informed consent, comply with the investigational study protocol and return for all study visits.

Who cannot join

  • Patients with Polypoidal Choroidal Vasculopathy (PCV) as evidenced on Indocyanine Green Angiography (ICG).
  • Previous treatment with photodynamic therapy (PDT), external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy.
  • CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia.
  • Geographic atrophy involving the foveal center in the study eye.
  • Any retinal vascular disease or retinal degeneration other than AMD in the study eye.
  • Any significant disease in the study eye that could compromise best-corrected visual acuity.
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  • Cataract surgery in the study eye within three months of screening.
  • Trabeculectomy or aqueous shunt or valve in the study eye.
  • Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of baseline.
  • Females of child bearing potential that are pregnant or not using medically acceptable contraception; males unwilling to take adequate contraceptive measures.
  • Serious allergy to or prior significant adverse reaction to fluorescein.
  • Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigators judgment, represent a safety concern.
  • Severe cardiac disease, symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization, or arterial thrombosis within 12 months of start of study drug, inadequately controlled hypertension, or ventricular tachyarrhythmias requiring ongoing treatment.
  • QTc ≥450 msec or subjects with a history of risk factors for Torsades de Pointes.
  • Stroke or transient ischemic attack within 12 months of trial entry.
  • Clinically significant impaired renal or hepatic function.
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082.
  • Serious active infection, other serious medical condition or any other condition that would impair the ability of the subject to administer the investigational drug or to adhere to the study protocol requirements.
  • Presence of any condition which, in the judgment of the investigator, would prevent the subject from completing the study.
  • Need to take any medicine that is a strong inhibitor or inducer of CYP3A4.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Tongren Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100730

  • West China Hospital

    Chengdu, Sichuan, 610041

  • The First People's Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200080

  • The Eye Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325027

Other trials in China

About this study

Official title: Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD.

Read the detailed description

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD. Patients will receive one of four doses for up to four weeks. Single/multiple dose pharmacokinetics in these patients will be studied. At the end of four weeks, investigator will evaluate safety and tolerability and decide whether to continue treatment for a total of six months to further evaluate safety and preliminary efficacy.

Being tested
CM082 tablet
Medical subject headings
Macular Degeneration

What participants receive

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

  • CM082 tabletDrug

    Also called X-82

    CM082 tablets taken orally

Study groups in NCT02452385
Study groupRoleWhat they receive
CM082 tabletExperimentalEscalating dose of CM082 tablet starting at 25mg once a day
Receives: Drug: CM082 tablet

What is being measured

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

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Incidence of the adverse event after treatment

    Measured: six months

Secondary outcomes (3)

  1. Area under the plasma concentration versus time curve (AUC) of CM082

    Single/multiple dose pharmacokinetics in Chinese wAMD patients

    Measured: four weeks

  2. Change in best corrected visual acuity (BCVA) (in number of letters)

    Change from baseline in mean BCVA (ETDRS)

    Measured: six months

  3. Change in Central Retinal Thickness

    Change from baseline in mean central retinal thickness (OCT)

    Measured: six months

Timeline

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

  1. First posted22 May 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Why it stopped: Sponsor requirements

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452385
Sponsor's protocol ID
CM082-OPH-101
Status last verified
Jan 2020
First submitted
10 Mar 2015
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Gao Y, Lu F, Li X, Dai H, Liu K, Liu X, Sun Z, Xiang J, Ding L, Liang C, Wang Y, Shen Z, Zhang M. Safety and tolerability of oral vorolanib for neovascular (wet) age-related macular degeneration: a phase I, open-label study. Eye (Lond). 2023 Oct;37(15):3228-3233. doi: 10.1038/s41433-023-02496-x. Epub 2023 Apr 11.

    PubMed 37041349

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CM082 tablet in people with Age-Related Macular Degeneration, run by AnewPharma at 6 sites 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 5 inclusion and 20 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: paused, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: six 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 NCT02452385, which also lists 1 linked publication.

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 13 Jan 2020.

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