Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378196
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2006-09-18
Brief Title:
Ranibizumab in Idiopathic Parafoveal Telangiectasia RIPT Trial
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Ranibizumab in Idiopathic Parafoveal Telangiectasia RIPT Trial
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 03 mg or 05 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 03 mg005 ml or 05 mg005 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 2020 or better or retinal center point thickness 225 microns
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 03 mg005 ml or 05 mg005 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 2020 or better or retinal center point thickness 225 microns
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None