Choroidal neovascularization secondary to pathologic myopia MedDRA version: 14.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 100000004853
Conditions
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent given before any study related procedure is performed; 2. Male or Female patients = 18 years of age; 3. 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); 4. BCVA > 24 letters and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Patients with inability to comply with study related procedures; 2. Presence of confirmed systolic blood pressure > 150 mmHg or diastolic > 90 mmHg at the time of enrollment; 3. History of stroke; 4. 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; 5. Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrollment; 6. 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); 7. History of pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time; 8. History of intraocular treatment with any anti-vascular endothelial growth factor (VEGF), vPDT and any intra-ocular surgery or corticosteroids administration within one month before study entrance; 9. Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation; 10. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational treatment; 11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. In case of use of oral contraception, women should have been stably on the same pill for a minimum of 3 months before taking investigational treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential; 12. Simultaneous participation in a study that includes administration of any investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate current criteria driving re-treatment in patients affected by CNV secondary to PM and experiencing a relapse of the disease after the first administration of ranibizumab. The criteria for re-treatment may consist in patient subjectivity or a clinical decision (described through clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG).;Secondary Objective: • To evaluate the mean changes in BCVA at 6M and 12M versus baseline. • To evaluate the number of injections of ranibizumab administered over the 12-month study period • To evaluate the time to relapse/re-treatment • To generate additional safety and tolerability data of ranibizumab in patients with visual impairment due to PM, administered as per currently approved EU label recommendation. • To evaluate changes in the quality of life after ranibizumab injection, by means of IVI Questionnaire.;Primary end point(s): To investigate current criteria driving re-treatment in patients affected by CNV secondary to PM and experiencing a relapse of the disease after the first administration of ranibizumab.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the mean changes in BCVA at 6M and 12M versus baseline; - To evaluate the number of injections of ranibizumab administered over a 12-month study period; - To evaluate time to relapse/re-treatment; - To generate additional safety and tolerability data regarding ranibizumab in patients with visual impairment due to PM, administered as per currently approved EU label recommendation; - To evaluate changes in quality of life after ranibizumab injection by means of IVI Questionnaire.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactDrug Regulatory Affairs
NOVARTIS FARMA
Outcome results
None listed