Retinal Physician

JAN-FEB 2017

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60 R E T I N A L P H Y S I C I A N . C O M | N O V E M B E R / D E C E M B E R 2 0 1 6 60 CLINICAL TRIAL UPDATE R E T I N A L P H Y S I C I A N | J A N U A R Y / F E B R U A R Y 2 0 1 7 study eye; choroidal neovascularization (CNV) due to causes other than AMD; proliferative diabetic retinopathy in either eye Information: Study: DRAW: A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet AMD Sponsor: University of Nebraska/Regeneron Purpose: To study the way that aflibercept injection behaves in the eye and in the body of patients with wet macular degeneration, in patients who have had previous vitreous removal surgery Design: Nonrandomized, Pharmacokinetics, Single Group, Open Label Number of Patients: 15 Inclusion Criteria: Active neovascular AMD, with no history of treatment in the study eye; patients with non-vitrectomized eyes; patients with vitrectomized eyes; phakic and pseudophakic eyes are allowed in the study; willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures Exclusion Criteria: Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion) that could affect the VEGF levels within the eye; known hypersensitivity to aflibercept; autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/ scleritis, blepharitis of either eye; infectious conjunctivitis, keratitis, or endophthalmitis of either eye Information: Study: AVENUE: A Proof-of-Concept Study of RG7716 in Participants With Choroidal Neovascularization (CNV) Secondary to AMD Sponsor: Hoffman-La Roche Purpose: To evaluate the safety, tolerability, pharmacokinetics, and efficacy of RG7716 in participants with subfoveal CNV Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 271 Inclusion Criteria: Subfoveal CNV lesions of all types, secondary to AMD; active CNV Exclusion Criteria: CNV due to causes other Information: Study: PREVENT: Prophylactic Ranibizumab for Exudative AMD Sponsor: Southern California Desert Retinal Consultants Purpose: To determine whether quarterly injections of ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration Design: Randomized, Efficacy, Parallel Assignment, Single-blind, Prevention Number of Patients: 100 Inclusion Criteria: Nonexudative age-related macular degeneration (AMD) in one eye (study eye); history of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment Exclusion Criteria: Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), etc. Information: Study: X-82 to Treat AMD Sponsor: Tyrogenex Purpose: To evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD Design: Randomized, Safety/Efficacy, Single Group, Double-blind Number of Patients: 132 Inclusion Criteria: Participants must have wet AMD that has been diagnosed and treated with anti-VEGF in one or both eyes for at least 1 year prior to joining the study and has required at least three prior injections of Eylea at intervals of not greater than 6 weeks for the past three injections in the eye that is selected to be the study eye; must have demonstrated the ability to achieve a dry macula in the study eye 14 days following an injection of Eylea at Screening Visit 1; ETDRS BCVA of 20 letters (20/400) or better in both eyes Exclusion Criteria: Previous vitrectomy to the WET AMD SStudy: Study of DS-7080a for the Treatment of Neovascular AMD Sponsor: Daiichi Sankyo Inc. Purpose: To test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration Design: Randomized, Safety/Efficacy, Parallel Assignment, Open Label Number of Patients: 45 Inclusion Criteria: Active primary subfoveal CNV lesions secondary to AMD; CNV ≥ 50% of total lesion size in study eye; central sub-field thickness > 315 µm on SD-OCT in the study eye Exclusion Criteria: Presence of RPEl tears or rips involving the macula in the study eye; history of any vitreous hemorrhage within 4 weeks prior to screening visit; the presence of causes of CNV other than AMD; prior vitrectomy Information: Study: A Phase 3 Safety and Efficacy Study of Fovista (E10030) Intravitreous Administration in Combination With Lucentis Compared to Lucentis Monotherapy Sponsor: Ophthotech Corp. Purpose: To evaluate the safety and efficacy of intravitreal administration of Fovista administered in combination with Lucentis compared to Lucentis monotherapy in subjects with subfoveal choroidal neovascularization secondary to AMD Design: Interventional, Randomized, Safety/ Efficacy, Parallel Assignment, Double-blind Number of Patients: 622 Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component; presence of sub- retinal hyper-reflective material (SD-OCT) Exclusion Criteria: Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals; any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids); any intraocular surgery or thermal laser within 3 months of trial entry; any prior thermal laser in the macular region

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