High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia
Condition: Retinal Diseases; Telangiectasis
MeSH terms: Retinal Diseases; Telangiectasis
Intervention: ranibizumab 2.0mg
Intervention description: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Idiopathic Parafoveal Telangiectasia; Macular Telangiectasia; Macula Lutea/pathology; Retinal Diseases/pathology; Retinal Pigments/metabolism; Telangiectasis/metabolism; Telangiectasis/pathology

Summary:

      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.
    

Eligibility criteria:

        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 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.