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Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Primary Purpose

Choroidal Neovascularization, Myopia, Degenerative

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Combretastatin A-4 Phosphate
Sponsored by
Mateon Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring subfoveal choroidal neovascularization, pathologic myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Provide written informed consent
  • Be able and willing to follow instructions
  • Age 18 to 50 years old (inclusive)
  • Have area of CNV within 50 um or under the geometric center of the foveal avascular zone Have greatest linear dimension of lesion 5,400 um or less, with >/=50.0% of the lesion composed of CNV (features which obscure the boundaries of the CNV such as blood, serous pigment epithelial detachment or blocked fluorescence must occupy <50.0%) as confirmed by Doheny Image Reading Center (DIRC)
  • Have best corrected distance visual acuity (ETDRS) of 20/20 to 20/200 (LogMAR +0.0 to 1.0), inclusive in the qualifying eye(s)
  • Have pathologic myopia presenting - 6.0 diopters or more correction required OR an axial length of the >/= 26.5 mm
  • Be able and willing to avoid any medication that the investigator feels may interfere with the study
  • If female and of childbearing potential, agree to submit a sample for pregnancy testing and have a negative pregnancy test within 1 day prior to each treatment. Females are considered of childbearing potential unless they are surgically sterile or post-menopausal for 12 months. Females of childbearing potential must agree to an approved form of contraception for the duration of the study.

Exclusion Criteria:

  • Have contraindications, allergies or sensitivity to the use of the study medications
  • Have clinical signs or symptoms, in the opinion of the investigator, that may interfere with the study
  • Features of any condition other than pathologic myopia associated with CNV, such as age-related macular degeneration
  • Have a tear of the retinal pigmented epithelium
  • Have undergoing ocular therapy/surgery or major surgery in the last 3 months or have any surgeries planned during the study period
  • Have any significant illness or condition, ocular or systemic that could, in the opinion of the investigator, be expected to interfere with the study
  • Have angina (stable or severe, even if controlled with medications), 6 months S/P myocardial infarction ,congestive heart failure, history of or presence of any clinically significant supraventricular or ventricular arrhythmias or syncope episodes
  • Have ECG with QTc >450 msdec or other clinically significant abnormalities such as left bundle branch block, left ventricular hypertrophy, etc.
  • Have uncontrolled QTc prolongation
  • Take any drugs known to prolong the QTc interval however subject can remain eligible if a non-QTc substitute can be administered
  • Have uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
  • Uncontrolled hypokalemia and/or hypomagnesemia
  • Have symptomatic peripheral vascular disease or cerebrovascular disease
  • Have psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
  • Be receiving concurrent hormonal therapy with exception of Gonadotropin-releasing hormone agonists in subjects with hormone refractory prostate cancer, hormone replacement therapy, oral contraceptive, and megestrol acetate used for anorexia/cachexia
  • Be receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency
  • Be a woman who is currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
  • Have participated in an investigational drug or device trial within 30 days of entering the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    36 mg/m2 Combretastin A-4 Phosphate

    45 mg/m2 Combretastatin A-4 Phosphate

    27 mg/m2 Combretastatin A-4 Phosphate

    Arm Description

    Outcomes

    Primary Outcome Measures

    Visual acuity line change from baseline at 3-month following
    Visual acuity response category at 3-month follow-up

    Secondary Outcome Measures

    Visual acuity line change from baseline at 1 month follow-up
    Visual acuity response category at 1 month follow-up
    Number of patients with treatment emergent adverse events

    Full Information

    First Posted
    August 22, 2011
    Last Updated
    October 28, 2011
    Sponsor
    Mateon Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01423149
    Brief Title
    Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
    Official Title
    A Phase II, Dose Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects With Pathologic Myopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mateon Therapeutics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36 and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal neovascularization in subjects with pathologic myopia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choroidal Neovascularization, Myopia, Degenerative
    Keywords
    subfoveal choroidal neovascularization, pathologic myopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Non-Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    36 mg/m2 Combretastin A-4 Phosphate
    Arm Type
    Experimental
    Arm Title
    45 mg/m2 Combretastatin A-4 Phosphate
    Arm Type
    Experimental
    Arm Title
    27 mg/m2 Combretastatin A-4 Phosphate
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Combretastatin A-4 Phosphate
    Other Intervention Name(s)
    CA4P, fosbretabulin
    Intervention Description
    Combretastatin A-4 Phosphate is administered on Day 0 and Day 7 (+/- 2 days). If the treating ophthalmologist notes any leakage from CNV in the study eye on a fluorescein angiography during the study or an increase in subretinal fluid on an optical coherence tomography measurement, retreatment with Combretastatin A-4 Phosphate is recommended with up to 3 additional treatments. The retreatment visit(s) could occur during a scheduled visit or at an additional visit 1 week after a regular study visit. A post-retreatment follow-up visit is necessary.
    Primary Outcome Measure Information:
    Title
    Visual acuity line change from baseline at 3-month following
    Time Frame
    from baseline to 3 months
    Title
    Visual acuity response category at 3-month follow-up
    Time Frame
    from baseline to 3 months
    Secondary Outcome Measure Information:
    Title
    Visual acuity line change from baseline at 1 month follow-up
    Time Frame
    from baseline to 1 month
    Title
    Visual acuity response category at 1 month follow-up
    Time Frame
    from baseline to 1 month
    Title
    Number of patients with treatment emergent adverse events
    Time Frame
    from first dose of study drug to 30 days after last dose of study drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide written informed consent Be able and willing to follow instructions Age 18 to 50 years old (inclusive) Have area of CNV within 50 um or under the geometric center of the foveal avascular zone Have greatest linear dimension of lesion 5,400 um or less, with >/=50.0% of the lesion composed of CNV (features which obscure the boundaries of the CNV such as blood, serous pigment epithelial detachment or blocked fluorescence must occupy <50.0%) as confirmed by Doheny Image Reading Center (DIRC) Have best corrected distance visual acuity (ETDRS) of 20/20 to 20/200 (LogMAR +0.0 to 1.0), inclusive in the qualifying eye(s) Have pathologic myopia presenting - 6.0 diopters or more correction required OR an axial length of the >/= 26.5 mm Be able and willing to avoid any medication that the investigator feels may interfere with the study If female and of childbearing potential, agree to submit a sample for pregnancy testing and have a negative pregnancy test within 1 day prior to each treatment. Females are considered of childbearing potential unless they are surgically sterile or post-menopausal for 12 months. Females of childbearing potential must agree to an approved form of contraception for the duration of the study. Exclusion Criteria: Have contraindications, allergies or sensitivity to the use of the study medications Have clinical signs or symptoms, in the opinion of the investigator, that may interfere with the study Features of any condition other than pathologic myopia associated with CNV, such as age-related macular degeneration Have a tear of the retinal pigmented epithelium Have undergoing ocular therapy/surgery or major surgery in the last 3 months or have any surgeries planned during the study period Have any significant illness or condition, ocular or systemic that could, in the opinion of the investigator, be expected to interfere with the study Have angina (stable or severe, even if controlled with medications), 6 months S/P myocardial infarction ,congestive heart failure, history of or presence of any clinically significant supraventricular or ventricular arrhythmias or syncope episodes Have ECG with QTc >450 msdec or other clinically significant abnormalities such as left bundle branch block, left ventricular hypertrophy, etc. Have uncontrolled QTc prolongation Take any drugs known to prolong the QTc interval however subject can remain eligible if a non-QTc substitute can be administered Have uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mm Hg irrespective of medication) Uncontrolled hypokalemia and/or hypomagnesemia Have symptomatic peripheral vascular disease or cerebrovascular disease Have psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol Be receiving concurrent hormonal therapy with exception of Gonadotropin-releasing hormone agonists in subjects with hormone refractory prostate cancer, hormone replacement therapy, oral contraceptive, and megestrol acetate used for anorexia/cachexia Be receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency Be a woman who is currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test Have participated in an investigational drug or device trial within 30 days of entering the study

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

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