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.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT02034006
- Phase
- PHASE3
- Status
- Completed
Conditions
- Choroidal Neovascularization Secondary to Pathologic Myopia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab — DRUGAll 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.
Study Details
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.
Key Dates
- First listed
- Jan 13, 2014
- Start date
- Jun 10, 2014
- Status verified
- Oct 2018
- Primary completion
- Jul 15, 2016
- Completion
- Jul 15, 2016
Study Design
- Enrollment
- 200 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RanibizumabPatients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection
Primary Outcome Measure
Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage [ Time Frame: Screening, Month 2, Month 6 ]