Clinical trial NCT00363168: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Official title: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Choroidal Neovascularization
Keywords: Hemorrhagic Choroidal Neovascularization
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-08-15
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-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.

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 or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness \<225 microns).

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.

Primary outcomes:
measure: Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.
timeFrame: 12 months
Secondary outcomes:
measure: Retinal Changes on Funduscopy
timeFrame: 12 months
measure: Retinal Thickness Measured by Optical Coherence Tomography (OCT)
timeFrame: 12 months
measure: Fluorescein Leakage on Fluorescein Angiography
timeFrame: 12 months
measure: Number of Subjects Experiencing Complications Related to Drug or Its Administration
timeFrame: 12 months after last injection
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Wilmer Eye Institute at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Neil M. Bressler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang MA, Do DV, Bressler SB, Cassard SD, Gower EW, Bressler NM. Prospective one-year study of ranibizumab for predominantly hemorrhagic choroidal neovascular lesions in age-related macular degeneration. Retina. 2010 Sep;30(8):1171-6. doi: 10.1097/IAE.0b013e3181dd6d8a.