Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363168
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Genentech, Inc.
Information provided by (Responsible Party):
Dr. Neil M. Bressler, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Drug: Ranibizumab Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
0.3 mg/0.05 ml dose of ranibizumab
Drug: Ranibizumab
0.3 mg/0.05 ml dose
Other Name: Lucentis
Experimental: B
0.5 mg/0.05 ml dose of ranibizumab
Drug: Ranibizumab
0.5 mg/0.05 ml dose
Other Name: Lucentis

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
    Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.

Secondary Outcome Measures :
  1. Retinal Changes on Funduscopy [ Time Frame: 12 months ]
  2. Retinal Thickness Measured by Optical Coherence Tomography (OCT) [ Time Frame: 12 months ]
  3. Fluorescein Leakage on Fluorescein Angiography [ Time Frame: 12 months ]
  4. Number of Subjects Experiencing Complications Related to Drug or Its Administration [ Time Frame: 12 months after last injection ]

    Potential complications included:

    • Deterioration of best-corrected visual acuity by 3 or more lines
    • Development of intraocular inflammation
    • Development of elevated intraocular pressure
    • Development of other ocular or systemic adverse effects.

    Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function.

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363168

United States, Maryland
The Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Genentech, Inc.
Principal Investigator: Neil M. Bressler, MD Johns Hopkins University

Publications of Results:
Responsible Party: Dr. Neil M. Bressler, Principal Investigator, Johns Hopkins University Identifier: NCT00363168     History of Changes
Other Study ID Numbers: NA_00001650
First Posted: August 15, 2006    Key Record Dates
Results First Posted: October 19, 2012
Last Update Posted: October 19, 2012
Last Verified: September 2012

Keywords provided by Dr. Neil M. Bressler, Johns Hopkins University:
Hemorrhagic Choroidal Neovascularization

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents