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.

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 10, 2014

Primary Completion Date

July 15, 2016

Study Completion Date

July 15, 2016

Conditions
Choroidal Neovascularization Secondary to Pathologic Myopia
Interventions
DRUG

Ranibizumab

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.

Trial Locations (31)

10122

Novartis Investigative Site, Torino

16035

Novartis Investigative Site, Rapallo

20100

Novartis Investigative Site, Milan

20122

Novartis Investigative Site, Milan

20132

Novartis Investigative Site, Milan

21100

Novartis Investigative Site, Varese

25015

Novartis Investigative Site, Desenzano del Garda

31015

Novartis Investigative Site, Conegliano

33100

Novartis Investigative Site, Udine

35100

Novartis Investigative Site, Padua

35128

Novartis Investigative Site, Padua

37024

Novartis Investigative Site, Negrar

39100

Novartis Investigative Site, Bolzano

40138

Novartis Investigative Site, Bologna

43100

Novartis Investigative Site, Parma

50134

Novartis Investigative Site, Florence

53100

Novartis Investigative Site, Siena

56124

Novartis Investigative Site, Pisa

60126

Novartis Investigative Site, Ancona

70124

Novartis Investigative Site, Bari

80131

Novartis Investigative Site, Napoli

80138

Novartis Investigative Site, Napoli

88100

Novartis Investigative Site, Catanzaro

90127

Novartis Investigative Site, Palermo

95123

Novartis Investigative Site, Catania

09124

Novartis Investigative Site, Cagliari

04019

Novartis Investigative Site, Terracina

06100

Novartis Investigative Site, Perugia

00133

Novartis Investigative Site, Roma

00161

Novartis Investigative Site, Roma

00198

Novartis Investigative Site, Roma

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY