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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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26 June 2012 |
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Main ID: |
EUCTR2005-005921-73-IT |
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Date of registration:
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14/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab 0.3 mg in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - ND
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Scientific title:
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A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab 0.3 mg in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - ND |
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Date of first enrolment:
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06/03/2006 |
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Target sample size:
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600 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005921-73 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Belgium
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Finland
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Germany
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Hungary
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Italy
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Netherlands
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Portugal
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Male or female patients 50 years of age or greater. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component. The total area of CNV encompassed within the lesion must be 50 of hte total lesion area
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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:
Previous treatment with intravitreally or intravenously administered Avasatin. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photodynamic therapy or pegaptanib sodium in the study eye within 30 days preceding day 1. Prior treatment in the study eye whit external-beam radiation terapy, vitreoctomy, or transpupillary thermotherapy.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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wet age-related macular degeneration of retina
MedDRA version: 6.1
Level: PT
Classification code 10025409
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Intervention(s)
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Product Name: LUCENTIS
Product Code: RFB002
Pharmaceutical Form: Eye drops, powder and solvent for solution
Current Sponsor code: RFB002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .3-
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Primary Outcome(s)
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Primary end point(s): the efficacy end-point best corrected visual acuity measured in number of letter.
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Main Objective: the primary objective of this study is to estimate the incidence of ocular adverse events in patients with CNV secondary to AMD who are treated whit 0,3 mg intravitreal ranibizumab
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Secondary Objective: To evaluate the mean change in best corrected visual acuity from baseline to months 3 and 12. To evaluate the mean change in retinal thickness as assessed with OCT from baseline to months 3 and 12. To evaluate the time to the first retreatment and the total number of treatments.
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Secondary ID(s)
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CRFB002A2303
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2005-005921-73-ES
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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