A Phase 1 interventional study of Ranibizumab and Ranibizumab in Telangiectasia, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-14.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
This research is being done to look at the effects of an experimental drug, ranibizumab, for the treatment of a condition called "idiopathic parafoveal telangiectasia" or IPT. IPT is caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.
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. Patients with IPT with macular edema documented on optical coherence tomography (OCT) but no choroidal neovascularization will be eligible for this study. Exclusion criteria will include other forms of retinopathy, active intraocular inflammation, history of poor vision due to conditions other than IPT in either eye, and known hypersensitivity to humanized monoclonal antibodies.
After obtaining informed consent, the patient will undergo baseline assessment including best-corrected Early Treatment for Diabetic Retinopathy Study (ETDRS) visual acuity, ocular examination, color fundus photography, fluorescein angiography, and OCT. If both eyes are eligible, the study participant and investigator will choose which eye to be considered the study eye. The study eye will be assigned at random to receive an intravitreal dose of ranibizumab (0.3 mg/0.05 ml or 0.5 mg/0.05 ml) at the baseline, 1 month, and 2 month visits. 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).
153 studies on the registry are indexed under Telangiectasis; 16 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 107 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
0.3 mg/0.05 ml dose of ranibizumab
Drug: Ranibizumab
0.5 mg /0.05 ml dose of ranibizumab
Drug: Ranibizumab
0.3 mg/0.05 ml dose
Also known as: Lucentis
0.5 mg/0.05 ml dose
Also known as: Lucentis
Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters
Time frame: 3 months
Retinal changes on ophthalmoscopy
Time frame: 3 months
Retinal thickness measured by Optical Coherence Topography (OCT)
Time frame: 3 months
Fluorescein leakage on fluorescein angiography
Time frame: 3 months
Complications related to drug or its administration
Time frame: 12 months after last injection
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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