VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)
Condition: Myopia, Pathological
MeSH terms: Myopia; Choroidal Neovascularization; Myopia, Degenerative; Neovascularization, Pathologic
Intervention: VEGF Trap-Eye (BAY86-5321); No Drug
Intervention description: 1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed; Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sham-controlled; pathologic myopia; mCNV; choroidal neovascularization; intravitreal injection; vision loss; macular damage

Summary:

      VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to
      choroidal neovascularization secondary to pathologic myopia. This will be a
      placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into
      the affected eye (and repeated injections if required), and 1 out of 4 patients will receive
      a sham injection requiring no needle stick, but making the patient unaware of whether or not
      he received active treatment.

      Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham
      patients may receive active treatment.

      Total duration of the study will be 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to read (or, if unable to read due to visual impairment, be read to verbatim by
             the person administering the informed consent form or a family member) and understand
             the informed consent form and willing to sign the informed consent form

          -  Signed informed consent form. In Japan only, the informed consent form for a subject
             under the age of 20 years will require the co-signature of the subject's legally
             authorized representative.

          -  Men and women ≥ 18 years of age

          -  Myopia of greater than or equal to -6 D OR axial length of greater than or equal to
             26.5 mm

          -  Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV
             secondary to pathologic myopia as defined by leakage on FA

          -  Best-corrected visual acuity of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200)
             in the study eye at 4 meters

          -  Decrease in vision in the study eye is determined by the investigator, using his/her
             medical judgment, to be primarily the result of the current active mCNV

          -  Willing, committed, and able to return for all clinic visits and complete all
             study-related procedures

        Exclusion Criteria:

          -  Only one functional eye

          -  Ocular media of insufficient quality to obtain fundus and OCT images in the study eye

          -  Greatest linear dimension (GLD) of the lesion in the study eye is greater than 12 disc
             areas

          -  Recurrent mCNV in the study eye

          -  Aphakia in the study eye

          -  History or presence of CNV with an origin other than pathologic myopia in the study
             eye

          -  Ocular inflammation or external ocular inflammation in the study eye

          -  Concurrent disease in the study eye that would compromise BCVA or require medical or
             surgical intervention during the study period

          -  Any ocular disorder in the study eye that, in the opinion of the investigator, may
             confound interpretation of the study results

          -  Significant scarring or atrophy in the fovea that indicates substantial irreversible
             vision loss in the study eye

          -  History of idiopathic or autoimmune-associated uveitis in either eye

          -  Evidence at examination of infectious blepharitis, keratitis, scleritis, or
             conjunctivitis in either eye or current treatment for serious systemic infection

          -  Vitreomacular traction or traction retinal detachment, epiretinal membrane in either
             eye

          -  Any iris neovascularization and/or vitreous hemorrhage in either eye

          -  Uncontrolled glaucoma, or previous filtration surgery in either eye

          -  Prior and concomitant treatments

          -  In the study eye:

               -  Any prior or concomitant treatment with another investigational agent for mCNV

               -  Any previous panretinal photocoagulation or subfoveal thermal laser therapy

               -  Any prior treatment with photodynamic therapy

               -  Cataract surgery within 3 months prior to Day 1

               -  Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1

               -  Any other intraocular surgery within 3 months prior to Day 1

               -  History of vitreoretinal surgery and/or scleral buckle surgery

          -  Any prior treatment with anti-VEGF agents

          -  Previous use of intraocular or periocular corticosteroids in either eye within 3
             months prior to Day 1

          -  Previous assignment to treatment during this study

          -  Uncontrolled hypertension

          -  History of cerebrovascular disease or myocardial infarction within 6 months prior to
             Baseline/Day 1

          -  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, may affect interpretation of the
             results of the study, or renders the subject at high risk from treatment complications

          -  Women of childbearing potential without contraception, women who intend to breastfeed
             during the study. All subjects (both men and women) of childbearing potential who are
             unwilling to use adequate birth control measures during the course of the study.

          -  Renal failure requiring dialysis or renal transplant

          -  Participation in an investigational study within 30 days prior to Screening/Visit 1
             that involved treatment with any drug (excluding vitamins and minerals) or device

          -  Known serious allergy to the fluorescein sodium for injection in angiography or
             Verteporfin

          -  Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality