Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia
Keywords: pathological myopia choroidal neovascularization ranibizumab mono-bilateral poor visual acuity retinal disease eye disease Angiogenesis Inhibitors Angiogenesis Modulating Agents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 200
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection

Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: All 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.

Protocol document: