Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen

Study Overview
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Brief Summary
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This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria. Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.

Official Title
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A Phase II, Open-label, Multicentre, 12 Month Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5mg) in Patients With Choroidal Neovascularisation Secondary to Pathological Myopia (PM)

Conditions
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Choroidal Neovascularisation

Intervention / Treatment
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* Drug: ranibizumab 0.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients of any race, aged 18 years or older Diagnosis of active primary or recurrent subfoveal or juxtafoveal CNV secondary to PM Diagnosis of high myopia of at least -6 dioptres in the study eye spherical equivalent. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must have been at least -6 dioptres Patients who have a BCVA score between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximately 6/9 - 6/96 Snellen equivalent) Patients must give fully informed consent and be willing and able to comply with all study procedures Exclusion Criteria: History of any surgical intervention in the study eye within two months preceding screening Previous macular laser photocoagulation, treatment with intravitreal steroids, verteporfin with photodynamic therapy (Visudyne®) or anti-VEGF agents ranibizumab, bevacizumab or pegaptanib sodium (Macugen®) in the study eye Previous treatment with intravenously administered bevacizumab (Avastin®) Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes History of allergic reaction to fluorescein Concurrent use of systemic anti-VEGF agents Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab 0.5mg<br> | Drug: ranibizumab 0.5mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference from baseline in mean Best Corrected Visual Acuity (BCVA) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in BCVA from baseline |  | 6 months | 
| Mean change in Central retinal Thickness (CRT) from baseline |  | 6 and 12 months | 
| Percentage of patients gaining ≥ 15 letters |  | 12 months | 
| Change in lesion size and morphology from baseline |  | 6 and 12 months | 
| Time to the first retreatment and the total number of treatments |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choroidal Neovascularisation, Pathological Myopia