Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Genentech
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00363168

Purpose

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.

Condition	Intervention	Phase
Choroidal Neovascularization	Drug: Ranibizumab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Resource links provided by NLM:

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Proportion of subjects avoiding 15 or more letter loss of best corrected visual acuity from baseline to 12 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retinal changes on funduscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Retinal thickness measured by Optical Coherence Tomography (OCT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Fluorescein leakage on fluorescein angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complications related to drug or its administration [ Time Frame: 12 months after last injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 0.3 mg/0.05 ml dose	Drug: Ranibizumab 0.3 mg/0.05 ml dose
B: Experimental 0.5 mg/0.05 ml dose	Drug: Ranibizumab 0.5 mg/0.05 ml dose

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363168

Locations

United States, Maryland
The Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Genentech

Investigators

Principal Investigator:

Neil M. Bressler, MD

The Johns Hopkins University School of Medicine

More Information

No publications provided

Responsible Party:	The Johns Hopkins University ( Neil M. Bressler, MD )
Study ID Numbers:	NA_00001650
Study First Received:	August 9, 2006
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00363168 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Hemorrhagic Choroidal Neovascularization

Study placed in the following topic categories:

Uveal Diseases
Eye Diseases
Metaplasia

Choroid Diseases
Neovascularization, Pathologic
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Eye Diseases
Metaplasia

Choroid Diseases
Neovascularization, Pathologic
Choroidal Neovascularization

ClinicalTrials.gov processed this record on September 02, 2009