Retinal Physician

JAN-FEB 2017

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65 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 CLINICAL TRIAL UPDATE on investigator review of clinical exam and SDOCT with central subfield thickness value of 325 microns by Zeiss Cirrus SD-OCT; E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye; history of previous treatment with anti- VEGF with at least four injections over the last 6 months Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME in the study eye; prior panretinal photocoagulation in the study eye within the past 3 months; prior intravitreal anti- VEGF therapy in the study eye within 30 days of enrollment; prior systemic anti- VEGF therapy, investigational or FDA- approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study; previous treatment with intravitreal aflibercept injection; significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam Information: mcowend@ccf.org Study: FAD: Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema Sponsor: Johns Hopkins University Purpose: To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME) and to collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME). Design: Safety/Efficacy, Single Group, Open Label Number of Patients: 50 Inclusion Criteria: Subjects receiving Iluvien as standard of care for DME Information: pcampo@jhmi.edu Exclusion Criteria: History of endophthalmitis in either eye; current inflammation in either eye; uncontrolled or symptomatic dry eye syndrome; intravitreal injection less than 3 months ago; history of anterior or posterior uveitis; history of post injection pain with prior treatments; recent thromboembolic event (<3 months) Information: arshad.khanani@gmail.com Study: PERMEATE: Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO Sponsor: Justis Ehlers/Regeneron Purpose: To evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion Design: Safety/Efficacy, Single Group, Open Label Number of Patients: 30 Inclusion Criteria: Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SD-OCT; ETDRS BCVA of 20/25 to 20/400 in the study eye Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye; prior panretinal photocoagulation in the study eye; prior intravitreal anti-VEGF therapy in the study eye; prior focal/grid laser photocoagulation Information: reesej3@ccf.org Study: Swap Two: Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab Sponsor: Rishi Singh, MD, Cleveland Clinic Foundation/Regeneron Purpose: To evaluate the safety and efficacy of treatment of diabetic macular edema with intravitreal aflibercept in subjects previously treated with intravitreal anti-VEGF agents (ranibizumab or bevacizumab) Design: Single Group, Open Label Number of Patients: 20 Inclusion Criteria: Foveal-involving retinal edema secondary to DME based OCT; best-corrected Visual Acuity (BCVA) of 0.3 to 1.2 Early Treatment Diabetic Retinopathy Study (ETDRS; Logarithmic minimum angle of resolution [logMAR]) in the study eye, with BCVA decrement primarily attributable to DME; treatment naïve (ie, no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye) Exclusion Criteria: Active proliferative diabetic retinopathy (PDR) in the study eye, such as neovascularization of the optic disc (NVD), neovascularization elsewhere (NVE), vitreous hemorrhage, or neovascular glaucoma; previous panretinal photocoagulation (PRP) in study eye or the need for panretinal photocoagulation (PRP) within 2 months from the time of study enrollment, based on the Investigator's opinion; previous focal laser photocoagulation within the foveal avascular zone; uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive measurements (during the same visit) or diastolic >100 mmHg on optimal medical regimen; screening glycated hemoglobin (HbA1c) blood test >12.0%; focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment Information: clinicaltrials@scifluor.com Study: Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With Diabetic Macular Edema Sponsor: Arshad Khanani, MD, Sierra Eye Associates/Genentech Purpose: To compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME Design: Randomized, Parallel Assignment, Single-blind Number of Patients: 100 Inclusion Criteria: Exam and OCT confirming diabetic macular edema; visual acuity of 20/400 or better; no history of post injection pain or inflammation in the past

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