visual impairment due to choroidal neovascularization secondary to pathologic myopia MedDRA version: 12.1 Level: LLT Classification code 10036803 Term: Progressive high (degenerative) myopia MedDRA version: 12.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization MedDRA version: 12.1 Level: LLT Classification code 10047571 Term: Visual impairment
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Product Code: RFB002F
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/ml milligr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female patients = 18 years of age 2. Written informed consent given before any study related procedure is performed 3. Diagnosis of active CNV secondary to PM confirmed by complete ocular examination in the study eye using the following criteria: • Presence of high myopia greater than -6D of spherical equivalence • Ocular ultrasonography or biometry demonstrating anterio-posterior elongation measurement greater than 26 mm • Presence of posterior changes compatible with the 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) seen by fundus ophthalmoscopy and fundus photography • Presence of active leakage from CNV seen by fluorescein angiography (FA) • Presence of intra or subretinal fluid seen by Optical coherence tomography (OCT) 4. At least one of the following lesion types is present in the study eye: • subfoveal (presence of anormal neovasculature in the avascular central fovea) • juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but less than 200 µ from the center) with involvement of the central macular area • extrafoveal (presence of abnormal neovasculature more than 200 µ from the center of the fovea) with involvement of the central macular area • margin of the optic disc (presence of abnormal neovasculature at peripapilar area) with involvement of the central macular area 5. BCVA > 24 letters and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with inability to comply with the study or follow procedures • 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 disease or it`s treatment, that could interfere with primary and/or secondary outcome evaluations including any medical condition that could be expected to progress, recur, or change to such an extend that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special 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) • Presence of amblyopia or ocular disorders with final best corrected vision <20/200 or amaurosis in the fellow eye • 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) or vPDT at any time in the study eye • History of intravitreal treatment with corticosteroids within 3 months prior to randomization in the study eye • History of intra-ocular surgery within 3 months prior to the randomization in the study eye. • Pregnant or nursing (lactating) women and Women of child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior efficacy of 0.5 mg ranibizumab driven by stabilization criteria and/or by disease activity re-treatment criteria vs. vPDT (verteporfin Photodynamic Therapy) as assessed by the difference between the average level of best corrected visual acuity (BCVA) (letters) over all monthly post-baseline assessments from Month 1 to Month 3 and the baseline level of BCVA.;Secondary Objective: To demonstrate non-inferiority of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria versus 0.5 mg ranibizumab intravitreal injections driven by stabilization criteria as assessed by the difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 6 and the baseline level of BCVA .;Primary end point(s): The primary efficacy variable is the difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 3 (endpoint) and the baseline level of BCVA. | — |
Countries
Austria, France, Germany, Hungary, Italy, Latvia, Lithuania, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed