NCT03710863

Brief Summary

This is a Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With wAMD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 22, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

October 15, 2018

Last Update Submit

January 8, 2020

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Dose-Limiting Toxicity(DLT)

    Any serious adverse event in eye or any ≥3 grade adverse reactions cannot be reduced to below grade 3 after treatment for more than 7 days.

    the first cycle(the first four weeks)

Secondary Outcomes (5)

  • Change in Best-Corrected Visual Acuity (BCVA)

    8 weeks

  • Change in Choroidal Neovascularization (CNV) size

    8 weeks

  • Change in Central Retinal Thickness

    8 weeks

  • Change in ERG

    8 weeks

  • Proportion Who Develop CNV in the Unaffected Fellow Eye

    8 weeks

Study Arms (1)

CM082 Tablet

EXPERIMENTAL

Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or unacceptable toxicity

Drug: CM082

Interventions

CM082DRUG

Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. The starting dose of 25mg BID will be increased by 100% to the maximum dose of 50mg BID.The treatment period is tentatively set at 1 year.

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 the discontinuation time is at least 5 drug half-lives.
  • ETDRS BCVA 20/400 to 20/32 in the study eye(s).
  • Adequate bone marrow, hepatic, and renal functions.
  • Willing to sign the ICF and comply with the study protocol.

You may not qualify if:

  • Patients with Polypoidal Choroidal Vasculopathy (PCV) as evidenced on Indocyanine Green Angiography (ICG).
  • Geographic atrophy involving the foveal center in the study eye.
  • 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.
  • Any significant disease in the study eye that could compromise best-corrected visual acuity.
  • Clinically significant impaired renal or hepatic function.
  • Stroke within 12 months of the first dose or transient ischemic attack within 12 months of the first dose.
  • Symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization, or arterial thrombosis within 6 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 or other severe ECG abnormalities which are clinically relevant.
  • 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 the first dose.
  • Allergy to the ingredients of the study drug.
  • Women of childbearing age who are pregnant, breast-feeding or not using medically acceptable contraception; males who are unwilling to take adequate contraceptive measures.
  • Need to take any medicine that is a strong inhibitor or inducer of CYP3A4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University, Hubei General Hospital

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

vorolanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Yin Shen

    Renmin Hospital of Wuhan University

    STUDY CHAIR

Central Study Contacts

Yin Shen, MD

CONTACT

86-13871550513yinshen@whu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 18, 2018

Study Start

November 22, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

CN(1)