intravitreal, VEGF Therapy, macula


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Article Date: 7/1/2013

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CT Update

CLINICAL TRIAL UPDATE

DRY AMD

Study: NEAMD: Non-exudative Age-related Macular Degeneration
Sponsor: Oregon Health and Science University
Purpose: To use OCT technology to compare how the retinal anatomy and blood flow differ within three severity groupings of non-exudative age-related macular degeneration
Design: Observational, Case Control, Prospective
Number of Patients: 20
Inclusion Criteria: Presence of mild, moderate or severe NEAMD; media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs; vision better than 20/200
Exclusion Criteria: Inability to maintain stable fixation for OCT imaging. A condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control); a concurrent ocular pathology that may contribute to vision loss (eg, CNV, glaucoma, visually significant cataract, optic neuropathy, diabetic retinopathy, history of retinal surgery) or interfere with acquisition of high-quality images; blood pressure > 180/110
Information: (503) 494-3000


Study: I-TEAM: Intervention Trial in Early Age-related Macular Degeneration
Sponsor: Newtricious R&D BV
Purpose: To assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of age-related macular degeneration
Design: Randomized, Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 120
Inclusion Criteria: many small drusen, or a few intermediate-sized (63-124 micrometres in diameter) drusen, or macular pigmentary changes
Exclusion Criteria: ocular media opacity (severe cataract); history of active small bowel disease or resection; atrophic gastritis; hyperlipidemia (LDL >120 mg/dL or triglycerides >400 mg/dL)
Information: ian.j.murray@manchester.ac.uk


Study: Study on Visual Function Impairments in Dry Age-related Macular Degeneration
Sponsor: Duke University
Purpose: To submit enrollees to the visual function testing
Design: Observational, Prospective
Number of Patients: 190
Inclusion Criteria: Has been diagnosed with dry age-related macular degeneration stages 1-3
Exclusion Criteria: Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
Information: (919) 684-9010


Study: SEATTLE: Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (SEATTLE)
Sponsor: Acucela, Inc.
Purpose: To determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 440
Inclusion Criteria: Clinical diagnosis of GA associated with AMD
Exclusion Criteria: Active CNV or presence of an active ocular disease; known serious allergy to the fluorescein sodium for injection in angiography; pre-specified laboratory abnormalities at screening; treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)
Information: clinicaltrials@acucela.com


Study: A Safety Study of CNTO 2476 in Patients With AMD
Sponsor: Janssen Research & Development
Purpose: To evaluate the safety and tolerability of CNTO 2476 administered subretinally
Design: Randomized, Safety/Efficacy, Single Group Assignment, Open Label, Treatment
Number of Patients: 56
Inclusion Criteria: Bilateral GA of the macula caused by AMD
Exclusion Criteria: Exudative AMD; evidence of other significant ophthalmologic disease; ocular hypertension; previous cell therapy other than blood components
Information: JNJ.CT@sylogent.com


Study: Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Sponsor: Alimera
Purpose: To compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 40
Inclusion Criteria: Bilateral GA secondary to AMD of ≥0.5 and ≤7 disc areas
Exclusion Criteria: GA secondary to any condition other than AMD in either eye; history of or current CNV or need for anti-angiogenic therapy; glaucoma or ocular hypertension
Information: lschulz@med.wayne.edu


Study: Study of Human Central Nervous System Stem Cells (HuCNS-SC) in AMD
Sponsor: StemCells, Inc.
Purpose: To investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to AMD
Design: Interventional, Safety/Eficacy, Single Group Assignment, Open Label, Treatment
Number of Patients: 16
Inclusion Criteria: Diagnosis of AMD with GA; only patients with a specific degree and extent of GA will be eligible
Exclusion Criteria: Prior vitreal or retinal surgery; glaucoma; atrophic macular disease of any other cause; diabetic retinopathy or DME
Information: kglocke@retinafoundation.org


Study: Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry AMD Including GA
Sponsor: Pfizer
Purpose: To determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, AMD including GA
Design: Randomized, Pharmacokinetics, Single Group, Double-blind, Treatment
Number of Patients: 24
Inclusion Criteria: Diagnosis of dry AMD including uni- or multi-focal GA without foveal involvement; BCVA of 20/50 or better
Exclusion Criteria: Ocular disease other than advanced AMD or GA in the study eye; history or diagnosis of exudative AMD, with subretinal or CNV lesions; medications known to be toxic to the lens, retina or optic nerve
Information: (800) 718-1021


Study: Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With GA Secondary to AMD
Sponsor: GlaxoSmithKline
Purpose: To determine the safety and efficacy of GSK933776 in the treatment of GA secondary to AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 162
Inclusion Criteria: Evidence of AMD confirmed by the presence of at least 1 drusen ≥125 microns; well-demarcated GA due to AMD
Exclusion Criteria: Additional eye disease that could compromise assessment of BCVA or imaging of the posterior pole; history of CNV; previous treatment for AMD, with the exception of dietary supplements
Information: GSKClinicalSupportHD@gsk.com


Study: Safety and Tolerability of Subretinal Transplantation of hESC-derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry AMD
Sponsor: Advanced Cell Technology
Purpose: To evaluate the effect of subretinal injection of human embryonic stem cell-derived RPE cells in patients with dry AMD and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies of RPE cellular therapy
Design: Interventional, Safety, Single Group Assignment, Open Label
Number of Patients: 12
Inclusion Criteria: Advanced dry AMD with evidence of one or more areas of > 250 microns of GA involving the central fovea
Exclusion Criteria: Presence of active or inactive CNV; presence or history of other retinal vascular or degenerative disease other than AMD; history of optic neuropathy
Information: schwartz@jsei.ucla.edu


Study: Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
Sponsor: MacuCLEAR, Inc.
Purpose: To assess the efficacy, safety, and tolerability of MC-1101 in patients with dry AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 60
Inclusion Criteria: Better than 20/80 ETDRS best-corrected visual acuity; mild to moderate nonexudative AMD
Exclusion Criteria: Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye; past or current other retinal or choroidal vasculopathy in study eye; uncontrolled hypertension (>150 systolic or >95 diastolic)
Information: pralston@macuclear.com


Study: Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration
Sponsor: Alcon Research
Purpose: To evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration
Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Basic Science
Number of Patients: 24
Inclusion Criteria: Diagnosis of age-related macular degeneration in study eye, as specified in protocol; poor visual acuity in study eye, as specified in protocol; willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment
Exclusion Criteria: Treatments to the study eye within 28 days prior to study treatment, as specified in protocol; any disease or medication expected to cause systemic or ocular immunosuppression
Information: alcon.medinfo@alcon.com




WET AMD

Study: NVAMD: Neovascular Age-related Macular Degeneration
Sponsor: Oregon Health and Science University
Purpose: To assess the utility of OCT angiography in the evaluation of NVAMD
Design: Observational, Case Control, Prospective
Number of Patients: 15
Inclusion Criteria: Presence of neovascular AMD confirmed by fluorescein dye leakage on angiogram or presence of at least one of the following on OCT: subretinal fluid, intraretinal fluid, or sub-retinal pigment epithelial fluid; treatment naïve group consists of individuals who have not received any treatment for neovascular AMD in the study eye; votive treatment group consists of individuals who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit
Exclusion Criteria: Inability to maintain stable fixation for OCT imaging; significant renal disease, deined as a history of chronic renal failure requiring dialysis or kidney transplant; a condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control); blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible; prior macular laser treatment; Subretinal hemorrhage or fibrosis >50% of choroidal neovascular lesion Visual acuity 20/200 or worse; an ocular condition is present such that, in the opinion of the investigator, may alter the retinal anatomy (eg, epiretinal membrane); an ocular condition is present (other than neovascular AMD) that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, etc.)
Information: (503) 494-3000


Study: Effects of Sildenafil on Choroidal Thickness in AMD
Sponsor: Duke University
Purpose: To compare choroidal thickness changes after a single-dose sildenafil treatment in AMD patients compared with age-matched controls
Design: Interventional, Nonrandomized, Efficacy, Single Group, Open Label
Number of Patients: 80
Inclusion Criteria: Has been diagnosed with AMD
Exclusion Criteria: History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries
Information: (919) 797-9111


Study: RE-VIEW: Study to Assess Best Corrected Visual Acuity in Patients With Neovascular AMD Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
Sponsor: Regeneron
Purpose: To evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI
Design: Interventional, Safety/Efficacy, Single Group, Open Label, Treatment
Number of Patients: 150
Inclusion Criteria: Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye; the CNV area must be at least 50% of total lesion size
Exclusion Criteria: Exudative AMD in the fellow eye; corneal endothelial measures as judged by an independent reading center; any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
Information: clinicaltrials@regeneron.com


Study: ATLAS: Repeated Eye Injections of Afibercept for Treatment of Wet AMD
Sponsor: Brian Burke, MPH/Regeneron
Purpose: To evaluate the visual outcome and number of injections required during an OCT-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular AMD
Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible; patients cannot have concurrent progressive retinal disease
Exclusion Criteria: Prior treatment for NVAMD in the study eye; prior experimental treatment of NVAMD; prior treatment with systemic anti-VEGF agents; prior treatment with verteporfin
Information: research@midatlanticretina.com


Study: Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular AMD
Sponsor: Genzyme
Purpose: To examine the safety and tolerability of an experimental gene transfer agen in patients with Neovascular AMD
Design: Interventional, Nonrandomized, Safety, Parallel Assignment, Open Label
Number of Patients: 34
Inclusion Criteria: CNV secondary to AMD, as confirmed by the patient’s medical history and a documented diagnosis of CNV; distance BCVA of 20/100 or worse
Exclusion Criteria: CNV in the study eye due to any reason other than AMD; history of conditions in the study eye during Screening which might alter visual acuity or interfere with study testing
Information: medinfo@genzyme.com


Study: Genetic Load and Phenotype in Aggressive AMD (RPED Genetics)
Sponsor: Sequenom, Inc.
Purpose: To examine cheek cell samples to determine if there is a correlation between genotype (DNA markers) and phenotype (the type of AMD the patient has)
Design: Observational, Cohort, Prospective
Number of Patients: 100
Inclusion Criteria: Subject agrees to provide two buccal swabs in accordance with this protocol
Exclusion Criteria: Previous sample donation under this protocol; presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss which have been present prior to age 50
Information: (415) 923-3482


Study: Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) AMD
Sponsor: Ohr Pharmaceuticals, Inc.
Purpose: To evaluate the safety and efficacy of topical squalamine lactate eye drops in treating patients with neovascular AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 120
Inclusion Criteria: A diagnosis of CNV secondary to AMD with total lesion area ≤ 12 disc areas with CNV affecting at least 50% of the total lesion area confirmed by FA
Exclusion Criteria: Neovascularization secondary to any condition other than AMD in the study eye; blood occupying greater than 50% of the AMD lesion
Information: itaraporewala@ohrpharmaceutical.com


Study: T-REX: Treat and Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
Sponsor: Charles C. Wykoff, MD, PhD/Genentech
Purpose: To maintain an exudation-free macula with the fewest number of office visits, tests and injections
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 60
Inclusion Criteria: Any CNVM lesion secondary to AMD; BCVA in the study eye between 20/32 and 20/400; the total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the total lesion
Exclusion Criteria: Subretinal hemorrhage in the study involving the center of the fovea
Information: karri.schuetzle@houstonretina.com

Study: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging (PVOCT)
Sponsor: University of California, San Francisco
Purpose: To determine whether phase variance optical coherence tomography (PVOCT), a software-based OCT image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography
Design: Observational, Cohort, Prospective
Number of Patients: 78
Exclusion Criteria: Any patients with ocular media opacities which prevent clear evaluation of the fundus by either FA or OCT
Information: smcclint@gmail.com

Study: Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)
Sponsor: Sequenom, Inc.
Purpose: To determine if there is an association between genetics, MPOD and the risk of progression to wet AMD
Design: Observational, Cohort, Prospective
Number of Patients: 150
Inclusion Criteria: Subject is diagnosed with either CNV, dry AMD or is an age-matched control; self-reported as non-Hispanic Caucasian
Exclusion Criteria: Previous donation
Information: jmcavinue@morriseyegroup.com

Study: Nexus: Efficacy and Safety Study of iSONEP With and Without Lucentis/Avastin to Treat AMD
Sponsor: Lpath, Inc./Pfizer
Purpose: To determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis or Avastin in subjects with wet AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 160
Inclusion Criteria: Subjects who have received 3-10 IVT injections of Lucentis or Avastin within 12 months prior to screening; active subfoveal CNV secondary to AMD
ExclusionCriteria: Most recent IVT injection of Lucentis or Avastin <28 days and >65 days prior to screening; previous PDT or Macugen at any time point; focal thermal laser or grid laser within 3 months prior to Day 0
Information: info@lpath.com

Study: Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Injection in Subjects With Exudative Macular Degeneration Previously Treated With Ranibizumab or Bevacizumab
Sponsor: Cleveland Clinic/Regeneron
Purpose:To examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections
Design: Observational, Case-only, Prospective
Number of Patients:25
Inclusion Criteria: Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by historical OCTs and angiograms
Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
Information:singhr@ccf.org

Study: Retinal and RPE Autoimmunity in AMD-Correlation With Lucentis Therapy (Antibody)
Sponsor: Lawrence S. Morse, MD/Genentech
Purpose: To determine if “wet” AMD patients differ from patients with “dry” AMD or normal eyes in the production of anti-RPE or anti-retinal antibody formation
Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Treatment
Number of Patients:131
Inclusion Criteria: Patients with active neovascular AMD naïve to treatment or treated with 4 or more monthly injections of anti-VEGF treatment without response
Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity; previous AMD therapy; patients being treated with immunomodulatory drugs
Information: lsmorse@ucdavis.edu

Study: Safety and Efficacy of Intravitreal LFG316 in Wet AMD
Sponsor: Novartis
Purpose: To assess the safety and efficacy of LFG316 in patients with AMD
Design: Randomized, Parallel Assignment, Single-blind, Treatment
Number of Patients: 57
Inclusion Criteria: BCVA of 60 letters or less in the study eye; an active CNV membrane attributable to neovascular AMD
Exclusion Criteria: History of recurrent non-response to anti-VEGF therapy; retinal disease other than AMD; CNV not due to AMD
Information: (862) 778-8300

Study: Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative AMD
Sponsor: Stanford University
Purpose: To determine whether patients who have switched from ranibizumab to VEGF Trap-Eye have comparable results
Design: Observational, Cohort, Prospective
Number of Patients: 590
Inclusion Criteria: Established diagnois of exidative AMD who have been switched from ranibizumab to VEGF Trap-Eye
Exclusion Criteria: Previous or concurrent history of treatment of other retinal diseases with agents other than ranibizumab
Information: (650) 723-6995

Study: Addition of 20 mg/Day Zeaxanthin to Triple Therapy Treatment Options for AMD
Sponsor: The Retina Center of St. Louis County, P.C./ZeaVision, Inc.
Purpose: To evaluate whether 20 mg per day of oral zeaxanthin as a supplement to patients with CNV and exudative AMD undergoing combination therapy with bevacizumab, dexamethasone and PDT laser photocoagulation improves outcomes
Design: Observational, Case Control, Retrospective
Number of Patients: 200
Inclusion Criteria: Subjects who have AMD with a CNV membrane either classic or occult in at least one eye; preoperative BCVA equal to or greater than 19 letters
Exclusion Criteria: Retinal disease not AMD
Information: rjolk@retina-stl.com

Study: Evaluation of AGN-150998 in Exudative AMD
Sponsor: Allergan
Purpose: To assess the safety of AGN-150998 administered as an intravitreal injection to patients with exudative AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 200
Inclusion Criteria: AMD; BCVA between 20/40 and 20/320
Exclusion Criteria: Nearsightedness of 8 D or more; history of or current glaucoma in the study eye; cataract surgery or Lasik within the last 3 months
Information: clinicaltrials@allergan.com

Study: COMPASS: Clinical Assessment Of AMD Patients After Early Diagnosis and Treatment With Ranibizumab
Sponsor: UC, San Diego/Genentech
Purpose: To determine if patients treated early after diagnosis of wet AMD can return/maintain to their baseline predisease BCVA
Design: Intervention, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Naïve wet-AMD within 4 months of disease onset for GALLEY patients and within 3 months of disease onset for all others; patients that have lost > 5 letters from baseline best vision; BCVA 20/25-20/320
Information: CJL015@ucsd.edu

Study: Study of Dark Adaptation in AMD
Sponsor: National Eye Institute
Purpose: To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry AMD
Design: Observational, Prospective
Number of Patients: 200
Inclusion Criteria: Group 0: No large drusen or advanced AMD; Group 1: At least one large drusen in the study eye and no large drusen or advanced AMD in the fellow eye; Group 2: Bilateral large drusen with or without RPE hypo/hyperpigmentary changes; Group 3: At least one large drusen in the study eye and advanced AMD in the fellow eye
Exclusion Criteria: Advanced AMD
Information: prpl@mail.cc.nih.gov

Study: CFH&AMD: Complement Factor H Haplotypes and Smoking in AMD
Sponsor: Department of Veterans Affairs
Purpose: To test the hypothesis that smoking increases AMD by increasing complement acti-vation and that this is positively correlated with known disease variations in the CFH gene
Design: Observational, Cohort, Prospective
Number of Patients: 300
Exclusion Criteria: Ocular diseases that might simulate AMD or preclude its diagnosis
Information: rohrer@musc.edu



DIABETIC MACULAR EDEMA

Study: Dextromethorphan for Diabetic Macular Edema
Sponsor: National Eye Institute
Purpose: To see if dextromethorphan can help treat diabetic macular edema
Design: Interventional, Safety/Efficacy, Single Group, Open Label, Treatment
Number of Patients: 8
Inclusion Criteria: BCVA ETDRS score of 34 letters or better (i.e., 20/200 or better) Definite retinal thickening due to diabetic macular edema based on clinical examination that is not refractory to further therapy
Exclusion Criteria: An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (eg, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition); an ocular condition is present
Information: meg.gordon@nih.gov

Study: ROTATE: Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab
Sponsor: Southeast Retina Center, Georgia/Genentech
Purpose: To determine the safety and efficacy of intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment)
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts); definite retinal thickening due to diabetic macular edema involving the center of the macula
Exclusion Criteria: Known allergy to ranibizumab; acute cardiovascular event requiring hospitalization within the past 3 months; systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study; macular edema is considered to be due to a cause other than DME
Information: dmarcus@southeastretina.com

Study: OPERA: Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl
Sponsor: Cleveland Clinic/Allergan
Purpose: To examine the use of the dexamethasone implant (Ozurdex) in patients with diabetic macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention
Design: Interventional, Single Group Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Patients who areundergoing pars plana vitrectomy for: epiretinal membrane/vitreomacular traction or diabetic macular edema; patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
Exclusion Criteria: History of active inflammatory eye disease (uveitis) (within 3 months); history of ocular malignancy and/or ocular/orbital irradiation; history of recent retinal vein occlusion (within 6 months)
Information: srivass2@ccf.org

Study: Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery
Sponsor: Lahey Clinc
Purpose: To assess the safety and efficacy of Ozurdex after vitrectomy
Design: Randomized, Safety/Efficacy, Single-group Assignment, Double-blind, Treatment
Number of Patients: 15
Inclusion Criteria: Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 microns with intraretinal cystic edema; BCVA between 20/40 to 20/400; patient had vitrectomy surgery
Exclusion Criteria: Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition; patient with history of steroid response with IOP >35mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection
Information: avon.p.stewart@lahey.org

Study: CDDR: Computer Detection of Diabetic Retinopathy Compared to Clinical Examination
Sponsor: IDx LLC
Purpose: To determine whether computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Board-certified ophthalmologist
Design: Observational, Case-only, Prospective
Number of Patients: 600
Inclusion Criteria: No history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed); other than cataract surgery
Exclusion Criteria: a history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc; previous intraocular surgery other than cataract; previous laser to the retina
Information: (713) 559-5200

Study: Protocol T: Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for DME
Sponsor: DRCR.net/NEI/Genentech/Regeneron
Purpose: To compare the efficacy and safety of (1) intravitreal aflibercept, (2) intravitreal-bevacizumab, and (3) intravitreal ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to 20/320
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Inclusion Criteria: BCVA between 20/32 and 20/320 within eight days of randomization; definite retinal thickening due to DME involving the center of the macula; DME present on OCT, within eight days of randomization
Exclusion Criteria: Macular edema is considered to be due to a cause other than DME; macular edema considered to be related to ocular surgery; vitreoretinal interface abnormalities are the primary cause of macular edema
Information: (863) 682-7474

Study: Ranibizumab and Bevacizumab for Diabetic Macular Edema
Sponsor: National Eye Institute
Purpose: To compare the effectiveness of ranibizumab and bevacizumab injections for diabetic macular edema
Design: Interventional, Randomized, Safety/Efficacy, Crossover Assignment, Doubleblind, Treatment
Number of Subjects: 60
Inclusion Criteria: Eye has a BCVA ETDRS score between 20/32 and 20/400; eye has definite retinal thickening or cystic changes due to DME based on clinical exam involving the center of the macula that is not refractory to further therapy as based on the investigator’s clinical judgment
Exclusion Criteria: Eye has an ocular condition present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (eg, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition); eye has an ocular condition present (other than DR) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
Information: wileyhe@mail.nih.gov

Study: Safety and Pilot Efficacy of AKB-9778 in Subjects With DME
Sponsor: Aerpio Therapeutics
Purpose: To evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with DME
Design: Interventional, Safety, Single Group Assignment, Open Label, Treatment
Number of Patients: 24
Inclusion Criteria: Decrease in vision determined to be primarily the result of DME in the study eye; definite retinal thickening due to diffuse DME involving the center of the macula in the study eye; mean central subfield thickness of at least 325 microns by OCT in the study eye.
Exclusion Criteria: Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening; prior pars plana vitrectomy within 12 weeks prior to Screening; any ocular surgery within 12 weeks prior to Screening; YAG capsulotomy within 7 days prior to Screening
Information: kpeters@aerpio.com

Study: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Sponsor: Retina Macula Institute/Allergan
Purpose: To test the efficacy of a 0.7-mg intravitreal dexamethasone implant on macular leakage and VA for patients with recalcitrant DME
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 20
Inclusion Criteria: Presence of NPDR or PDR as confirmed by FA; prior treatment with ≥ 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks; < 0.1 Log OCT decrease in macular edema on high resolution OCT between initial visit and following treatment with ≥ anti-VEGF injections
Exclusion Criteria: Injection of steroid medication within prior 3 months; evidence of significant GA on fluorescein angiography in the opinion of the treating physician; concurrent ocular disease that would limit visual acuity
Information: gina.kim@retinamaculainstitute.com

Study: DAVE: Efficacy and Safety Trial of Intravitreal Injections Combined With PRP for the Treatment of CSME Secondary to Diabetes Mellitus
Sponsor: Genentech/Greater Houston Retina
Purpose: To study the efficacy and safety of ranibizumab injection monotherapy verses a duel therapy of 0.5 mg ranibizumab combined with ultrawide, 200º field angiography guided panretinal photocoagulation in patients with CSME-CI secondary to diabetes mellitus
Design: Interventional, Randomized, Safety/Efficacy, Single Group, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: BCVA of 20/32 to 20/200; high-definition OCT central thickness measurement of ≥ 300µm; decrease in VA determined to be the result of DME
Exclusion Criteria: Prior ocular treatment; history of vitrectomy surgery in the study eye; any panretinal photocoagulation in the study eye; prior treatment with intraocular or subconjunctival steroids in the study eye
Information: dmbmd@houstonretina.com

Study: Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Sponsor: Retina Vitreous Associates of Florida/Genentech
Purpose: To determine whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than ranibizumab injections into the eye less frequently
Design: Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication; BCVA less than or equal to 20/40; central foveal thickness of >300 µm
Exclusion Criteria: Intraocular surgery less than 6 months ago; ERM of clinical significance; prior vitrectomy; uncontrolled glaucoma
Information: (727) 323-0077

Study: Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
Sponsor: Medical College of Wisconsin
Purpose: To determine the effects of short term (3 month) near-infrared light therapy on anatomic and functional abnormalities of DME as assessed by VA, OCT multifocal electroretinography and fundus bimicroscopy
Design: Interventional, Nonrandomized, Safety/Efficacy, Single Group Assignment, Open Label
Number of Patients: 20
Inclusion Criteria: Fellow eye meets criteria; able to successfully tolerate a 3-month deferral of laser photocoagulation
Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant; subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment
Information: hwhelan@mcw.edu

Study: Evaluation of Single Nucleotide Polymorphisms (SNPs) in Patients With and Without DME
sponsor: NEI/NIH Clinical Center
Purpose: To investigate genetic factors that may influence the development of DME
Design: Observational, Prospective
Number of Patients: 400
Inclusion Criteria: Participant is diagnosed with active DME defined by fluorescein leakage associated with either central retinal thickness greater than 260 microns on spectral domain OCT or cystic changes present on OCT; or participant has evidence of focal laser scars indicative of prior DME
Exclusion Criteria: Another retinal disease that may confound the evaluation of the DME; participant has opacities of the ocular media, or other problems sufficient to preclude adequate dilated examination
Information: (800) 411-1222

Study: GEM: Phase I Dose Escalation Safety Study of RetinoStat in Advanced AMD
Sponsor: Oxford BioMedica
Purpose: To examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular AMD
Design: Interventional, Safety, Single-group Assignment, Open Label, Treatment
Number of Patients: 18
Inclusion Criteria: Clinical diagnosis of AMD with active CNV that shows evidence of leakage; BCVA less than or equal to 20/200
Exclusion Criteria: Significant ocular abnormalities that prevent retinal assessment; treatment with steroids within three months of screening; treatment with anti-VEGF therapy within one month of screening
Information: pcampo@jhmi.edu

Study: Prospective Randomized Trial of Proton Beam Combined With Anti-VEGF Therapy for Exudative AMD
Sponsor: University of California, Davis
Purpose: To test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative AMD
Design: Randomized, Placebo Control, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 45
Inclusion Criteria: VA 20/40 to 20/400; lesion size <12 DA; submacular hemorrhage <75% of total lesion and not involving foveal center; submacular fibrosis <25% of total lesion
Exclusion Criteria: Previous treatment with photodynamic therapy or thermal laser; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon’s Kenalog within 6 months
Information: (916) 734-6074

Study: A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug) in the Treatment of Diabetic Macular Edema
Sponsor: Ampio Pharmaceuticals
Purpose: To evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of diabetic macular edema versus placebo
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 450
Inclusion Criteria: Stable diabetic and metabolic control (no major changes in diabetic or lipid reducing medications for 3 months prior to start of this study as determined by the Investigator)
Exclusion Criteria: Known allergy to any danazol (Cyclomen or Danocrine) or any other non-medicinal component of the danazol test drug (cornstarch, lactose, magnesium stearate, gelatin, and talc)
Information: hloose@ampiopharma.com



Retinal Physician, Volume: 10 , Issue: July 2013, page(s): 71 - 77

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