Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
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.
|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|
- 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.
- 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.
|Study Start Date:||August 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
0.3 mg/0.05 ml dose of ranibizumab
0.3 mg/0.05 ml dose
Other Name: Lucentis
0.5 mg/0.05 ml dose of ranibizumab
0.5 mg/0.05 ml dose
Other Name: Lucentis
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363168
|United States, Maryland|
|The Wilmer Eye Institute at Johns Hopkins|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Neil M. Bressler, MD||The Johns Hopkins University School of Medicine|