A randomized controlled multicentre study to assess the non-inferiority of the safety of bevacizumab compared to ranibizumab administered by intravitreal injection in patients with macular degeneration or other exudative not age-related macular

A randomized controlled multicentre open-label parallel arm study to assess the non-inferiority of the safety of bevacizumab compared to ranibizumab (allocation 4:1) administered by intravitreal injection in patients with macular degeneration or other exudative not age-related macular - SBR-ITA13

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000133-12-IT

Enrollment

1780

Registered

2014-06-27

Start date

2013-07-20

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Concentrate for solution for infusion Trade Name: LUCENTIS Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age-related macular degeneration or Diabetic retinal oedema or Retinal perivascular sheathing or Choroidal neovascularisation patients 2. Men/woman 3. age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500

Exclusion criteria

Exclusion criteria: 1. Patients treated with anti-VEGF intravitreal within the last six months prior the inclusion in the study 2. Pregnancy or breast-feending 3. Patients in emergency situation 4. Subjects inable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the non inferiority of the safety of treatment with bevacizumab vs ranibizumab, in particular about arteriothrombotic events or death at 2 years;Secondary Objective: 1. To evaluate the efficacy of the treatment with bevacizumab vs ranibizumab in terms of visual acuity at two years of the randomisation 2. To evaluate the proportion of the treatment with bevacizumab vs ranibizumab serious adverse events at two years of the randomisation 3. To evaluate the proportion of the treatment with bevacizumab vs ranibizumab gastrointestinal events at two years of the randomisation;Primary end point(s): Proportion of subjects reporting deaths or non fatal-stroke or myocardial infarction in the 2 years following randomization. Each subject is counted once if experiencing multiple events.;Timepoint(s) of evaluation of this end point: at 2 years	—

Measure

Time frame

Main Objective: To evaluate the non inferiority of the safety of treatment with bevacizumab vs ranibizumab, in particular about arteriothrombotic events or death at 2 years;Secondary Objective: 1. To evaluate the efficacy of the treatment with bevacizumab vs ranibizumab in terms of visual acuity at two years of the randomisation 2. To evaluate the proportion of the treatment with bevacizumab vs ranibizumab serious adverse events at two years of the randomisation 3. To evaluate the proportion of the treatment with bevacizumab vs ranibizumab gastrointestinal events at two years of the randomisation;Primary end point(s): Proportion of subjects reporting deaths or non fatal-stroke or myocardial infarction in the 2 years following randomization. Each subject is counted once if experiencing multiple events.;Timepoint(s) of evaluation of this end point: at 2 years

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Secondary

Measure	Time frame
Secondary end point(s): - Differences between the two groups in the visual acuity score at 24 months from randomization. The visual acuity score is assessed using differences in ETDRS letters from ETDRS charts. - Proportion of participants reporting serious adverse events or worse in the 2 years following randomisation. A serious adverse event is any untoward medical occurrence that at any dose: 1. Results in death 2. Is life-threatening at the time of the event 3. Requires in subject hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Is a congenital anomaly or birth defect - Proportion of participants reporting serious adverse gastrointestinal events or worse in the 2 years following randomisation. Gastrointestinal events considered are: abdominal hernia, abdominal pain, colitis ulcerative, constipation, duodenal ulcer haemorrhage, gastric polyps, gastric ulcer, gastric ulcer haemorrhage, gastritis, gastrointestinal haemorrhage, gastrooesophageal reflux disease, ileus, lower gastrointestinal haemorrhage, nausea, pancreatitis, rectal haemorrhage, small intestinal obstruction, vomiting;Timepoint(s) of evaluation of this end point: from inclusion in the study to 2 years	—

Measure

Time frame

Secondary end point(s): - Differences between the two groups in the visual acuity score at 24 months from randomization. The visual acuity score is assessed using differences in ETDRS letters from ETDRS charts. - Proportion of participants reporting serious adverse events or worse in the 2 years following randomisation. A serious adverse event is any untoward medical occurrence that at any dose: 1. Results in death 2. Is life-threatening at the time of the event 3. Requires in subject hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Is a congenital anomaly or birth defect - Proportion of participants reporting serious adverse gastrointestinal events or worse in the 2 years following randomisation. Gastrointestinal events considered are: abdominal hernia, abdominal pain, colitis ulcerative, constipation, duodenal ulcer haemorrhage, gastric polyps, gastric ulcer, gastric ulcer haemorrhage, gastritis, gastrointestinal haemorrhage, gastrooesophageal reflux disease, ileus, lower gastrointestinal haemorrhage, nausea, pancreatitis, rectal haemorrhage, small intestinal obstruction, vomiting;Timepoint(s) of evaluation of this end point: from inclusion in the study to 2 years

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Countries

Italy

Contacts

Public ContactUSRB

Azienda Ospedaliera Universitria Integrata Verona

supporto.noprofit@ospedaleuniverona.it+390458127043

Outcome results