Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Condition: Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab; Ranibizumab
Intervention description: 0.3 mg/0.05 ml dose; 0.5 mg/0.05 ml dose
Intervention MeSH terms: Ranibizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 7.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Hemorrhagic Choroidal Neovascularization

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-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.
    

Eligibility criteria:

        Inclusion Criteria:

        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 Criteria:

        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.