A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.
Condition: Choroidal Neovascularization Secondary to Pathologic Myopia
MeSH terms: Neoplasm Metastasis; Vision Disorders; Vision, Low; Myopia; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab
Intervention description: All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pathological myopia; choroidal neovascularization; ranibizumab; mono-bilateral; poor visual acuity; retinal disease; eye disease; Angiogenesis Inhibitors; Angiogenesis Modulating Agents

Summary:

      The primary objective of the study was to investigate current criteria driving re-treatment
      in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia
      (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Written informed consent given before any study related procedure is performed

          -  Diagnosis of active CNV secondary to PM confirmed by complete ocular examination in
             the affected eye(s) using the following criteria:

          -  Presence of high myopia greater than -6D of spherical equivalence

          -  Presence of posterior changes compatible with pathologic myopia (any signs of
             attenuation of retinal pigment epithelium (RPE) and choroids, mottling of the RPE,
             tilted disc, geographic atrophy of RPE, Fuchs spots, posterior staphyloma, submacular
             hemorrhage, lacquer cracks) detected by fundus ophthalmoscopy and fundus photography

          -  Presence of active leakage from CNV observed through fluorescein angiography (FAG)

          -  Presence of intra or subretinal fluid demonstrated by Optical Coherence Tomography
             (OCT)

          -  BCVA > 24 letters and < 78 letters tested at 4 meters staring distance using
             ETDRS-like visual acuity chart

          -  Visual loss must be only due to the presence of any eligible types of CNV related to
             PM based on clinical ocular findings, FAG and OCT. (Also patients that have for
             example 20/60 as their best visual acuity due to PM in their history and have
             additional vision loss due to CNV lesion can be included)

        EXCLUSION CRITERIA:

          -  Patients with inability to comply with study related procedures

          -  Pregnant or nursing (lactating) women and women of childbearing potential UNLESS using
             effective contraception during treatment

          -  Presence of confirmed systolic blood pressure > 150 mmHg or diastolic > 90 mmHg at the
             time of enrollment

          -  History of stroke

          -  Any type of advanced, severe or unstable medical condition or its treatment that could
             significantly bias the assessment of clinical status and interfere with primary and/or
             secondary outcome evaluations or put the patient at risk

          -  Presence of active infectious disease or intra-ocular inflammation in either eye at
             the time of enrollment

          -  Ocular disorders in the study eye that may confound interpretation of study results,
             compromise visual acuity or require medical or surgical intervention during the
             12-month study period (including retinal detachment, cataract and pre-retinal membrane
             of the macula)

          -  History of pan-retinal or focal/grid laser photocoagulation with involvement of the
             macular area in the study eye at any time

          -  History of intraocular treatment with any anti-vascular endothelial growth factor
             (VEGF), verteporfin photodynamic therapy (vPDT) and any intra-ocular surgery or
             corticosteroid administration within one month before study entrance

          -  Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation

          -  Simultaneous participation in a study that includes administration of any
             investigational drug