Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen
- Sponsor
- Novartis
- Study ID
- NCT01037348
- Phase
- PHASE2
- Status
- Completed
Conditions
- Choroidal Neovascularisation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ranibizumab 0.5mg — DRUG
Study Details
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'.
Key Dates
- First listed
- Dec 23, 2009
- Start date
- Jan 31, 2010
- Status verified
- Apr 2016
- Primary completion
- May 31, 2012
- Completion
- May 31, 2012
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ranibizumab 0.5mg
Primary Outcome Measure
The difference from baseline in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]