Status:
COMPLETED
Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-r...
Detailed Description
This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg ...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
- Age greater than 50 years.
- Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- Known hypersensitivity to humanized monoclonal antibodies
- History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
- History of stroke within 6 months of study entry.
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
- History of subfoveal laser treatment in the study eye.
- History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye.
- Ocular inflammation (including trace or above) in the study eye.
- Inability to comply with study or follow up procedures.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00363168
Start Date
August 1 2006
End Date
May 1 2009
Last Update
October 19 2012
Active Locations (1)
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1
The Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287