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Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Dr. Neil M. Bressler, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00363168
First received: August 9, 2006
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ]
  • Number of Subjects Experiencing Complications Related to Drug or Its Administration [ Time Frame: 12 months after last injection ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 7
Study Start Date: August 2006
Study Completion Date: May 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Publications:

Responsible Party: Dr. Neil M. Bressler, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00363168     History of Changes
Other Study ID Numbers: NA_00001650
Study First Received: August 9, 2006
Results First Received: April 3, 2012
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Hemorrhagic Choroidal Neovascularization

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Metaplasia
Pathologic Processes
 Choroid Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013