Back to results

CM082 in Patients With Myopic Choroidal Neovascularization (CNV)

Primary Purpose

Myopic Choroidal Neovascularisation

Status

Suspended

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CM082

About this trial

This is an interventional treatment trial for Myopic Choroidal Neovascularisation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of active CNV secondary to pathologic myopia and the study eye must have the following lesion characteristics: (a)presence of high myopia with greater than -6 diopters of spherical equivalencef or anteroposterior elongation greater than 26 mm, (b) presence of at least 1 of the following lesion types: subfoveal; juxtafoveal; extrafoveal with involvement of the central macular area and margin of the optic disk with involvement of the central macular area, (c) vision loss due to the above causes, (d) ETDRS BCVA 24 to 78 letters.
Patients with no previous anti-VEGF therapy.
Adequate bone marrow, hepatic, and renal functions.
Willing to sign the ICF and comply with the study protocol.

Exclusion Criteria:

CNV due to causes other than mCNV.
Any significant disease in the study eye that could compromise BCVA.
Active eye infection in any eye.
Previous treatment with photodynamic therapy (PDT), external beam radiation, laser photocoagulation, or transpupillary thermotherapy within
1 month of the first dose.
Intraocular surgery in the test eye within 3 months prior to the first dose.
Any eye received intravitreal injection of corticosteroids within 3 months prior to first dose.
Clinically significant, uncontrolled cardiovascular and cerebrovascular disease.
Patients who had previously used strong inhibitors of CYP3A or strong inducers were discontinued from the first dose of CM082 <5 drug half-lives (except for withdrawals longer than 14 days).
Active hepatitis B (serum HBV DNA ≥ 500 IU / ml), hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive.
Swallowing dysfunction, active gastrointestinal disease, or other diseases that affect the absorption, distribution, metabolism, and excretion of drugs.
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.
Patients who have fertility needs and who cannot use effective methods of contraception during the study period and at least 3 months after the end of treatment (except for male patients after birth control or female patients after birth control or postmenopausal).

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CM082 Tablet

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Adverse event

Incidence of the adverse event after treatment

Secondary Outcome Measures

Change in Best-Corrected Visual Acuity (BCVA)

Change from baseline in mean BCVA (ETDRS)

Change in Choroidal Neovascularization (CNV) size

Change from baseline in mean CNV size (FA)

Change in Central Retinal Thickness

Change from baseline in mean central retinal thickness (OCT)

Full Information

NCT ID

NCT04222842

First Posted

January 7, 2020

Last Updated

March 7, 2021

Sponsor

AnewPharma

1. Study Identification

Unique Protocol Identification Number

NCT04222842

Brief Title

CM082 in Patients With Myopic Choroidal Neovascularization (CNV)

Official Title

Phase I Study of CM082 in Patients With Myopic Choroidal Neovascularization (CNV)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Suspended

Why Stopped

Day is not required for Anticipated dates.

Study Start Date

December 18, 2019 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AnewPharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This is a multicenter, open-label, single-arm, phase I Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with mCNV. The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2). Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles. There are three dose levels, 25mg BID,50mg QD and 50mg BID. The total treatment period is tentatively set at 3 cycles (12 weeks). Based on data from dose escalation studies, identify safe and effective doses for expanded enrollment studies.The assessment of the safety and efficacy will be done in 2、4、8、12weeks after the first dose.Also, single/multiple dose pharmacokinetics in these patients will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopic Choroidal Neovascularisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CM082 Tablet

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CM082

Other Intervention Name(s)

X-82

Intervention Description

Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles.The total treatment period is tentatively set at 3 cycles (12 weeks).

Primary Outcome Measure Information:

Title

Dose-Limiting Toxicity(DLT)

Description

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.

Time Frame

the first cycle(the first four weeks)

Title

Adverse event

Description

Incidence of the adverse event after treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Best-Corrected Visual Acuity (BCVA)

Description

Change from baseline in mean BCVA (ETDRS)

Time Frame

12 weeks

Title

Change in Choroidal Neovascularization (CNV) size

Description

Change from baseline in mean CNV size (FA)

Time Frame

12 weeks

Title

Change in Central Retinal Thickness

Description

Change from baseline in mean central retinal thickness (OCT)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of active CNV secondary to pathologic myopia and the study eye must have the following lesion characteristics: (a)presence of high myopia with greater than -6 diopters of spherical equivalencef or anteroposterior elongation greater than 26 mm, (b) presence of at least 1 of the following lesion types: subfoveal; juxtafoveal; extrafoveal with involvement of the central macular area and margin of the optic disk with involvement of the central macular area, (c) vision loss due to the above causes, (d) ETDRS BCVA 24 to 78 letters. Patients with no previous anti-VEGF therapy. Adequate bone marrow, hepatic, and renal functions. Willing to sign the ICF and comply with the study protocol. Exclusion Criteria: CNV due to causes other than mCNV. Any significant disease in the study eye that could compromise BCVA. Active eye infection in any eye. Previous treatment with photodynamic therapy (PDT), external beam radiation, laser photocoagulation, or transpupillary thermotherapy within 1 month of the first dose. Intraocular surgery in the test eye within 3 months prior to the first dose. Any eye received intravitreal injection of corticosteroids within 3 months prior to first dose. Clinically significant, uncontrolled cardiovascular and cerebrovascular disease. Patients who had previously used strong inhibitors of CYP3A or strong inducers were discontinued from the first dose of CM082 <5 drug half-lives (except for withdrawals longer than 14 days). Active hepatitis B (serum HBV DNA ≥ 500 IU / ml), hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive. Swallowing dysfunction, active gastrointestinal disease, or other diseases that affect the absorption, distribution, metabolism, and excretion of drugs. 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. Patients who have fertility needs and who cannot use effective methods of contraception during the study period and at least 3 months after the end of treatment (except for male patients after birth control or female patients after birth control or postmenopausal).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Youxin Chen

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Learn more about this trial

CM082 in Patients With Myopic Choroidal Neovascularization (CNV)

We'll reach out to this number within 24 hrs