Status:
COMPLETED
High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia
Lead Sponsor:
Eye Center of Northern Colorado, P.C.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Retinal Diseases
Telangiectasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Idiopathic Parafoveal Telangiectasia (IPT) \[also known as Idiopathic Perifoveal Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia (MacTel)\] is a disorder of...
Detailed Description
DESCRIPTION OF THE STUDY This is an open-label, Phase I/II study of intravitreally administered ranibizumab in subjects with nonproliferative Idiopathic Parafoveal Telangiectasia (IPT). Consented, e...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Presence of nonproliferative IPT confirmed by fluorescein angiography and spectral-domain OCT
- Age greater than 18
- Vision equal to or worse than 20/25 and better than or equal to 20/400 by ETDRS chart, without co-existing choroidal neovascularization.
- Physical ability and reasonable expectation to maintain all follow-up appointments.
Exclusion
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous ophthalmologic investigation or trial
- Any patient with proliferative diabetic retinopathy, diabetic macular edema, uveitis, history of ocular trauma, severe glaucoma, neovascular age-related macular degeneration
- Duration of previous treatment of IPT that exceeds two years.
- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either:
- Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or
- If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of Best Corrected Visual Acuity (BCVA) over the study period
- Prior/Concomitant Treatment:
- Previous steroids (oral) within 30 days preceding Day 0
- Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
- Prior participation in a Genentech ranibizumab clinical trial within 60 days.
- History of receiving intravitreal injections of ranibizumab, bevacizumab, pegaptanib, or any other intravitreal medication within 60 days of first injection. History of receiving intravitreal or subtenons triamcinolone within 90 days of first injection.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01205035
Start Date
October 1 2010
End Date
October 1 2012
Last Update
April 10 2015
Active Locations (1)
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1
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525