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Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD (CNV)

Primary Purpose

Choroidal Neovascularization, Myopia, Punctate Inner Choroidopathy (PIC)

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bevacizumab (Avastin; Genentech, Inc.)
Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age > 18 years
  • Clinical diagnosis of choroidal neovascularization secondary to the following causes: ocular histoplasmosis, toxoplasmosis, idiopathic, angioid streaks, choroidal ruptures, intraocular inflammation (without signs of active uveitis i.e. multifocal choroiditis), central serous retinopathy and pathologic Myopia.

Only one eye will be assessed in the study. If both eyes are eligible, the investigator and patient will determine which eye is to be treated, considering such factors as disease duration, and likelihood of response to treatment.

  • Clear media and dilation to permit good stereo fundus photography
  • Evidence of active CNV present on OCT images manifest by subretinal fluid, intraretinal fluid or retinal thickening ≥ 250 µm
  • Best corrected VA in the study eye must be 20/40 and to 20/400 at 4 meters using ETDRS protocol.

Exclusion Criteria:

Pregnancy or lactation

  • Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; and IUD; or contraceptive hormone implant or patch.
  • CNV secondary to AMD
  • Diabetic Retinopathy
  • Prior enrollment in clinical studies in the study eye
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Previous participation in another simultaneous medical investigation or trial within 1 month preceding Day 0 (excluding vitamins and minerals)
  • Use of drug or treatment related or unrelated to their condition within 30 days prior to enrollment (Verteporfin, pegaptanib, ranibizumab, bevacizumab, triamcinilone or other AMD therapy in study eye)
  • Concurrent use of systemic anti-VEGF therapy
  • Any other ocular condition the investigator believes would pose a significant hazard to the subject if investigational treatment were initiated
  • History of allergy to fluorescein
  • Inability to obtain fundus photographs or FAs of sufficient quality to document CNV
  • Inability to comply with study or follow-up procedures
  • History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
  • Current treatment for active systemic infection
  • History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
  • Family history of glaucoma
  • Patients who have undergone intraocular surgery within last 2 months
  • Aphakia or absence of the posterior capsule in the study eye Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Monotherapy

    Combination therapy

    Arm Description

    Bevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings

    Intravitreal injection of bevacizumab 1.25 mg (Avastin; Genentech, Inc.) combined with reduced fluence PDT(Visudyne®; Novartis,) and 200 ug of intravitreal dexamethasone(4mg/ml, American regent, Inc) on Day 0 and then monthly retreatment with bevacizumab as-needed and triple therapy every 3 months as-needed.

    Outcomes

    Primary Outcome Measures

    Mean number of treatments per group

    Secondary Outcome Measures

    Mean change in visual acuity from baseline
    Mean change in visual acuity from baseline Proportion of subjects losing ≤8 letters (≈1.5 lines) from baseline Proportion gaining ≥15 letters from baseline Proportion with a Snellen equivalent of 20/200 or worse (legal blindness = 20/200 or worse in both eyes) Mean change from baseline in total area of CNV and total area of leakage from CNV from baseline to month 12 by FA Mean change in central subfield macular thickness (CMT) measured by OCT from baseline to month 12 Change of in areas of hypoautofluorescence (indicating atrophy) from baseline to month 12

    Full Information

    First Posted
    October 29, 2010
    Last Updated
    January 13, 2014
    Sponsor
    Massachusetts Eye and Ear Infirmary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01256580
    Brief Title
    Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD
    Acronym
    CNV
    Official Title
    Pilot Study of Intravitreal Bevacizumab vs. Combination Therapy for Choroidal Neovascularization Secondary to Causes Other Than Age-related Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of eligible subjects.
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    March 2013 (Anticipated)
    Study Completion Date
    September 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Massachusetts Eye and Ear Infirmary

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV) due to other causes. The limitation of this type of treatment is the necessity for frequent intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy in combination with photodynamic therapy can reduce the number of treatments needed with monotherapy while achieving similar visual results. There are ongoing multicenter trials evaluating combination therapy in patients with wet AMD but no similar trial for patients with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on patients with CNV not due to AMD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choroidal Neovascularization, Myopia, Punctate Inner Choroidopathy (PIC), Multifocal Choroiditis, Ocular Histoplasmosis Syndrome, Central Serous Chorioretinopathy (CSC), Angioid Streaks, Trauma, or Hereditary Eye Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Monotherapy
    Arm Type
    Active Comparator
    Arm Description
    Bevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings
    Arm Title
    Combination therapy
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal injection of bevacizumab 1.25 mg (Avastin; Genentech, Inc.) combined with reduced fluence PDT(Visudyne®; Novartis,) and 200 ug of intravitreal dexamethasone(4mg/ml, American regent, Inc) on Day 0 and then monthly retreatment with bevacizumab as-needed and triple therapy every 3 months as-needed.
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab (Avastin; Genentech, Inc.)
    Intervention Description
    1.25 mg bevacizumab (Avastin; Genentech, Inc.) by intravitreal injection
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy
    Intervention Description
    Intravitreal injection of 1.25 mg bevacizumab (Avastin; Genentech, Inc.) combined with reduced-fluence verteporfin PDT (Visudyne®; Novartis) and 200ug of intravitreal dexamethasone
    Primary Outcome Measure Information:
    Title
    Mean number of treatments per group
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Mean change in visual acuity from baseline
    Description
    Mean change in visual acuity from baseline Proportion of subjects losing ≤8 letters (≈1.5 lines) from baseline Proportion gaining ≥15 letters from baseline Proportion with a Snellen equivalent of 20/200 or worse (legal blindness = 20/200 or worse in both eyes) Mean change from baseline in total area of CNV and total area of leakage from CNV from baseline to month 12 by FA Mean change in central subfield macular thickness (CMT) measured by OCT from baseline to month 12 Change of in areas of hypoautofluorescence (indicating atrophy) from baseline to month 12
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age > 18 years Clinical diagnosis of choroidal neovascularization secondary to the following causes: ocular histoplasmosis, toxoplasmosis, idiopathic, angioid streaks, choroidal ruptures, intraocular inflammation (without signs of active uveitis i.e. multifocal choroiditis), central serous retinopathy and pathologic Myopia. Only one eye will be assessed in the study. If both eyes are eligible, the investigator and patient will determine which eye is to be treated, considering such factors as disease duration, and likelihood of response to treatment. Clear media and dilation to permit good stereo fundus photography Evidence of active CNV present on OCT images manifest by subretinal fluid, intraretinal fluid or retinal thickening ≥ 250 µm Best corrected VA in the study eye must be 20/40 and to 20/400 at 4 meters using ETDRS protocol. Exclusion Criteria: Pregnancy or lactation Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; and IUD; or contraceptive hormone implant or patch. CNV secondary to AMD Diabetic Retinopathy Prior enrollment in clinical studies in the study eye Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Previous participation in another simultaneous medical investigation or trial within 1 month preceding Day 0 (excluding vitamins and minerals) Use of drug or treatment related or unrelated to their condition within 30 days prior to enrollment (Verteporfin, pegaptanib, ranibizumab, bevacizumab, triamcinilone or other AMD therapy in study eye) Concurrent use of systemic anti-VEGF therapy Any other ocular condition the investigator believes would pose a significant hazard to the subject if investigational treatment were initiated History of allergy to fluorescein Inability to obtain fundus photographs or FAs of sufficient quality to document CNV Inability to comply with study or follow-up procedures History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications. Current treatment for active systemic infection History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye Family history of glaucoma Patients who have undergone intraocular surgery within last 2 months Aphakia or absence of the posterior capsule in the study eye Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ivana K Kim, MD
    Organizational Affiliation
    Massachussetts Eye& Ear Infirmary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD

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