Retinal Physician

JAN-FEB 2017

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

Contents of this Issue

Navigation

Page 65 of 71

64 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 64 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 CLINICAL TRIAL UPDATE DIABETIC MACULAR EDEMA Study: Anti-VEGF Treatment for Prevention of PDR/DME Sponsor: Jaeb Center for Health Research Purpose: To determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 322 Inclusion Criteria: No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed); no evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization. The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned; no center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds Exclusion Criteria: Exam or photographic evidence of vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR; history of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR; history of prior PRP (defined as ≥100 burns outside of the posterior pole); an ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (eg, retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.) Information: www.jaeb.org Study: DIME: Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema Sponsor: Allergan/California Retinal Consultants Purpose: To compare the effectiveness of using a dexamethasone steroid implant vs monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema Design: Randomized, Efficacy, Parallel Assignment, Open Label Number of Patients: 40 Inclusion Criteria: Clinical evidence of retinal thickening due to macular edema involving the center of the macula associated with diabetic retinopathy; previous history of anti-vegf treatment for diabetic macular edema (DME) with documented incomplete resolution of central subfield thickening by spectral- domain optical coherence tomography (SD-OCT). At least four intravitreal anti-vegf injections within the past 6 months prior to the baseline study visit are required for eligibility; central diabetic macular edema present on clinical examination and SD- OCT testing with central 1 mm subfield thickness greater than 300 microns as measured on SD-OCT at the baseline visit; visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 74 letters (20/32) by the ETDRS visual acuity protocol Exclusion Criteria: An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (eg, presence of subretinal fibrosis or geographic atrophy); presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (eg, AMD, uveitis, Irvine-Gass); evidence of active neovascularization of the iris or retina; evidence of central atrophy or fibrosis in the study eye; presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study; history of vitreous surgery in the study eye Information: sarahf@californiaretina.com Study: HULK: Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema Sponsor: Clearside Biomedical, Inc. Purpose: To demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus Design: Nonrandomized, Safety/Efficacy, Parallel Assignment, Open Label Number of Patients: 20 Inclusion Criteria: DME with central involvement in the study eye; ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye Exclusion Criteria: Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye; history of any previous ophthalmic surgeries in the study eye within 90 days of screening; subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti- VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only); subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only) Information: kathleen.billman@ clearsidebio.com Study: Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Diabetic Macular Edema Sponsor: SciFluor Life Sciences Purpose: To evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with diabetic macular edema Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 40 Inclusion Criteria: Retinal thickening secondary to type 1 or type 2 diabetes mellitus with diabetic macular edema (DME) defined as central subfield thickness ≥325 microns (µm) on spectral domain

Articles in this issue

Links on this page

Archives of this issue

view archives of Retinal Physician - JAN-FEB 2017