Register:
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EUCTR |
Last refreshed on:
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16 May 2022 |
Main ID: |
EUCTR2014-004048-36-HU |
Date of registration:
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10/03/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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This study is to determine if ranibizumab injected into the eye is superior to laser therapy in the treatment of retinopathy of prematurity (ROP). The study will assess the ability of these treatments to lead to regression of active ROP and prevent the development of ocular complications that are associated with poor visual outcome.
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Scientific title:
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RAINBOW extension study: an extension study to evaluate the long term efficacy and safety of RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy of prematurity - RAINBOW Extension study |
Date of first enrolment:
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19/04/2016 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004048-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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