Clinical Trial: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

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 Summary: 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).
Sponsor: Johns Hopkins University

Current Primary Outcome: 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.


Original Primary Outcome: 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.

Current Secondary Outcome:

  • Retinal Changes on Funduscopy [ Time Frame: 12 months ]
  • Retinal Thickness Measured by Optical Coherence Tomography (OCT) [ Time Frame: 12 months ]
  • Fluorescein Leakage on Fluorescein Angiography [ Time Frame: 12 months ]
  • 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.



Original Secondary Outcome:

  • Retinal Changes on Funduscopy
  • Retinal thickness measured by Optical Coherence Topography (OCT)
  • Fluorescein Leakage on Fluorescein Angiography
  • Complications related to drug or its administration


Information By: Johns Hopkins University

Dates:
Date Received: August 9, 2006
Date Started: August 2006
Date Completion:
Last Updated: September 18, 2012
Last Verified: September 2012