Retinal Physician

JAN-FEB 2017

Issue link: http://retinalphysician.epubxp.com/i/783300

Contents of this Issue

Navigation

Page 62 of 71

61 R E T I N A L P H Y S I C I A N | N O V E M B E R / D E C E M B E R 2 0 1 6 61 CLINICAL TRIAL UPDATE R E T I N A L P H Y S I C I A N . C O M | J A N U A R Y / F E B R U A R Y 2 0 1 7 contralateral eye and better than the study eye; ≥50 years of age; subfoveal CNV of any type Exclusion Criteria: Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis Information: clinicaloperations@rxipharma. com Study: Proton Radiation Therapy for Macular Degeneration Sponsor: University of Florida Purpose: To determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane Design: Safety, Single Group, Open Label Number of Patients: 10 Inclusion Criteria: Patients with subfoveal neovascular membranes identified on fluorescein angiography; visual acuity (best corrected vision) 20/200 or worse in affected eye; patient must be 50 years of age or older at time of consent; patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab) Exclusion Criteria: History of diabetes Information: (877) 686-6009 Study: EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection Sponsor: University of California-San Diego/ Regeneron Purpose: To evaluate individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration Design: Single Group, Open Label Number of Patients: 100 Inclusion Criteria: Naïve neovascular wet-age- related macular degeneration (has not received treatment before) Exclusion Criteria: Previous therapy in study eye for age-related macular degeneration or other retinal disease which may be used in the treatment of age-related macular degeneration; previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; history of vitrectomy, submacular surgery, or other surgical intervention for age-related macular degeneration in the study eye; any concurrent intraocular condition in the study eye Information: cwen@ucsd.edu injections within approximately 2 months prior to the screening visit; patient may have received up to six ITV anti-VEGF injections prior to the screening visit; demonstrated response to prior standard of care Exclusion Criteria: Study eye treatment with ITV bevacizumab within 5 months prior to the randomization visit, or with ITV aflibercept within 3 months prior to the randomization visit; history of laser photocoagulation, Visudyne, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD Information: (888) 662-6728 Study: CDER: A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular AMD Sponsor: Allergan Purpose: To study abicipar pegol in patients with neovascular AMD Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 900 Inclusion Criteria: Untreated or previously treated choroidal neovascularization (CNV) lesion due to AMD; BCVA of approximately 20/200 Snellen or better in the non-study eye; diagnosis of AMD in at least 1 eye; BCVA of 20/40 to 20/320 in the study eye and 20/200 or better in the other Exclusion Criteria: History of vitrectomy, macular surgery, or glaucoma surgery in the study eye; cataract or refractive surgery in the study eye within the last 3 months Information: clinicaltrials@allergan.com Study: Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD Sponsor: RXi Pharmaceuticals Purpose: To evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration Design: Safety/Efficacy, Open Label, Single Group Number of Patients: 9 Inclusion Criteria: Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/200 potentially due to subretinal fibrosis involving the fovea; BCVA ≥20/800 in the than AMD; subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area; cataract surgery within 3 months of baseline Information: global.rochegenentechtrials@ roche.com Study: A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative AMD Sponsor: Santen Inc. Purpose: To evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration Design: Nonrandomized, Safety/Efficacy, Single Group, Open Label Number of Patients: 12 Inclusion Criteria: Diagnosis of subretinal or intraretinal fluid secondary to exudative age- related macular degeneration; prior treatment in the study eye with any intravitreal anti-VEGF medication; at least one lesion in the study eye that meets minimal pathology criteria Exclusion Criteria: Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1; uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye Information: clinicaltrials@santeninc.com Study: LADDER: Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular AMD Sponsor: Genentech Purpose: To evaluate the efficacy and the safety of three different formulations of ranibizumab, delivered via the Ranibizumab Port Delivery System (RPDS) implant, in patients with subfoveal neovascular age- related macular degeneration Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 220 Inclusion Criteria: Newly diagnosed with wet AMD within 6 months of screening visit; patient must have received at least two ranibizumab

Articles in this issue

Links on this page

Archives of this issue

view archives of Retinal Physician - JAN-FEB 2017