High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | October 2010 |
| End Date: | October 2012 |
| Contact: | Arthur Korotkin, M.D. |
| Email: | drkorotkin@gmail.com |
| Phone: | (970) 221-2222 |
High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia [HD-LIPT]
Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal
Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia
(MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass
classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always
symmetric disorder. It is characterized in its early stages by dilation and loss of
parafoveal capillaries accompanied by angiographic leakage, "right angle" venules, central
and parafoveal intraretinal cysts, refractile crystaline retinal deposits, pigment
epithelial changes and intraretinal migration, foveal thinning, vision loss, and lack of
other retinal or systemic vascular disease. In its later (proliferative) stage, 5-10% of
patients will progress to choroidal neovascularization with accompanying fluid leakage,
hemorrhage, and further vision loss. The disease commonly occurs in the fourth to sixth
decade of life, and has no gender or racial predilection.
While the underlying etiology of IPT is unknown, telangiectatic vessels, angiographic
leakage, and intraretinal fluid cysts observed by OCT have led to a hypothesis that this
disorder may be driven by Vascular Endothelial Growth Factor (VEGF). VEGF, a growth factor
secreted throughout the body (including the eye) has been identified as a key molecule in
the pathogenesis of diverse vascular disorders of the eye such as neovascular Age-Related
Macular Degeneration (AMD), diabetic retinopathy, radiation retinopathy, retinopathy of
prematurity, and retinal venous occlusions. In many of those disorders blockade of VEGF
activity by molecules such as pegaptanib (Macugen) and ranibizumab (Lucentis) has been found
beneficial therapeutically.
Inclusion Criteria:
- 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 Criteria:
- 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 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.
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