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Sponsors and Collaborators: |
Aleris Helse Novartis |
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Information provided by: | Aleris Helse |
ClinicalTrials.gov Identifier: | NCT00567697 |
A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.
Condition | Intervention | Phase |
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Central Retinal Vein Occlusion Macular Edema |
Drug: ranibizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO |
Estimated Enrollment: | 32 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
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A: Active Comparator
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
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Drug: ranibizumab
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
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B: Sham Comparator |
Drug: ranibizumab
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have macular edema in the study eye with the following characteristics as determined by fluorescein angiography:
Exclusion Criteria:
Contact: Bettina Kinge, MD DMSc | Bettina.Kinge@retinaklinikken.no |
Norway | |
Bettina Kinge, Retinaklinikken Aleris | Recruiting |
Oslo, Norway, 0264 | |
Contact: Bettina Kinge, MD DMSc Bettina.Kinge@retinaklinikken.no | |
Contact: Per Bjorn Stordahl, MD per.bjorn.stordahl@retinaklinikken.no | |
Principal Investigator: Bettina Kinge | |
Ingar Stene Johansen | Recruiting |
Oslo, Norway | |
Contact: Ingar Stene-Joohansen ingar.stene-johansen@ulleval.no | |
Sub-Investigator: Ingar Stene-Johansen | |
Vegard Forsaa | Recruiting |
Stavanger, Norway | |
Contact: Vegard Forsaa forsaa@gmail.com | |
Kristian Fossen | Recruiting |
Tromsø, Norway | |
Contact: Kristian Fossen Kristian.Fossen@unn.no |
Principal Investigator: | Bettina Kinge, MD DMSc | Aleris Helse, Oslo |
Responsible Party: | Bettina Kinge ( Aleris Helse, Oslo, Norway ) |
Study ID Numbers: | ROCC study 2007 |
Study First Received: | December 3, 2007 |
Last Updated: | December 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00567697 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
ranibizumab CRVO macular edema sham |
Eye Diseases Vascular Diseases Retinal Degeneration Edema Macular Degeneration Thrombosis Macular Edema Signs and Symptoms Methamphetamine |
Embolism and Thrombosis Embolism Retinal Vein Occlusion Neoplasm Metastasis Amphetamine Venous Thrombosis Retinal Diseases Retinal degeneration |
Cardiovascular Diseases |