Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
NCT ID: NCT00557791
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2009-11-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Lucentis® (0.5 mg) every 4 weeks.
ranibizumab
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
B
Bevasiranib (1.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
C
Bevasiranib (2.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
D
Bevasiranib (2.5 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
Interventions
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Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
ranibizumab
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
* The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
* Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.
Exclusion Criteria
* Any intraocular surgery of the study eye within 12 weeks of screening
* Previous posterior vitrectomy of the study eye
* Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.
50 Years
ALL
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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Opko Health
Principal Investigators
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Naveed Shams, MD
Role: STUDY_DIRECTOR
SVP at Opko Health
Other Identifiers
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ACU302
Identifier Type: -
Identifier Source: org_study_id
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