Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Completed · Phase 1

Conditions studied: Choroidal Neovascularization

In brief

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-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.

Key facts

Study ID

NCT00363168

Run by

Johns Hopkins University

People needed

7

Starts

2006-08-01

Expected to finish

2009-05-01

Last updated by the study team

2012-10-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Wilmer Eye Institute at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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