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NOT RANDOMISED OPEN LABEL STUDY TO COMPARE EFFICACY OF BEVACIZUMAB (AVASTIN, ROCHE) VERSUS RANIBIZUMAB (LUCENTIS, NOVARTIS) ADMINISTERED BY INTRAVITREAL INJECTION IN PATIENTS WITH EXUDATIVE AGE RELATED MACULAR DEGENERATION WITH VISUAL ACUITY >= 2/10 - ND

NOT RANDOMISED OPEN LABEL STUDY TO COMPARE EFFICACY OF BEVACIZUMAB (AVASTIN, ROCHE) VERSUS RANIBIZUMAB (LUCENTIS, NOVARTIS) ADMINISTERED BY INTRAVITREAL INJECTION IN PATIENTS WITH EXUDATIVE AGE RELATED MACULAR DEGENERATION WITH VISUAL ACUITY >= 2/10 - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021968-15-IT
Enrollment
Unknown
Registered
2010-08-20
Start date
2010-08-06
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

exudative age related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10015902

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentratio

Sponsors

AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients with exudative age related macular degeneration with visual acuity >= 2/10 - Patients free from heart ischemic, pulmonary, cerebral diseases, deep venous thrombosis of lower extremities - Male and female - Age >50 - One eye treatment (according to specialistic instruction) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with exudative age related macular degeneration with visual acuity < 2/10 - Other exudative maculopathies not age related - Patients with heart ischemic, pulmonary, cerebral diseases, deep venous thrombosis of lower extremities - Pregnancy or nursing

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the efficacy of treatment with bevacizumab vs ranibizumab in terms of visual acuity (data from historical controls);Secondary Objective: To effect a pharmacoeconomic evaluation of treatments, by cost minimization analysis;Primary end point(s): The visual acuity change from baseline to 12 months measured in twenty vision—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026