Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

Telangiectasia Clinical Trial

Official title: Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Telangiectasia
• Telangiectasis

• NCT number: NCT00378196
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: Phase 1
• Start date: September 2006
• Completion date: December 2008