NCT02452385

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

5.3 years

First QC Date

March 10, 2015

Last Update Submit

January 8, 2020

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

    Incidence of the adverse event after treatment

    six months

Secondary Outcomes (3)

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

    four weeks

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

    six months

  • Change in Central Retinal Thickness

    six months

Study Arms (1)

CM082 tablet

EXPERIMENTAL

Escalating dose of CM082 tablet starting at 25mg once a day

Drug: CM082 tablet

Interventions

CM082 tabletDRUG

CM082 tablets taken orally

Also known as: X-82
CM082 tablet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Tongren Hospital，Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

The First People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200080, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

vorolanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Ming Zhang, MD

    West China Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

May 22, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

CN(6)