intravitreal, VEGF Therapy, macula


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Article Date: 1/1/2013

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Clinical Trial Update

CLINICAL TRIAL UPDATE

DRY AMD

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/Efficacy, 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: Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With AMD
Sponsor: Physician Recommended Nutriceuticals/Wills Eye
Purpose: To assess the effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with AMD.
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 100
Inclusion Criteria: AREDS category 3 or 4.
Exclusion Criteria: Patients with a known fish allergy; patients currently taking supplementation with omega-3 fatty acids and have an omega-3 index of greater than 4%.
Information: research@midatlanticretina.com

Study: Sirolimus for Advanced Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To determine if sirolimus can help prevent vision loss in people with GA.
Design: Interventional, Randomized, Safety/Efficacy, Single Group Assignment, Open Label, Treatment
Number of Patients: 15
Inclusion Criteria: Participant must have atleast one large druse (greater than or equal to 125 μm) in each eye; participants must not have any evidence or history of exudative disease related to AMD in either eye as determined by a recent FA performed within 4 months of study; steady fixation in both eyes in the foveal or parafoveal area and media clear enough for good quality photographs.
Exclusion Criteria: Evidence of disease other than AMD that may confound the outcome; history of macular laser or PDT; intravitreal injection of anti-VEGF agent for exudative AMD at any point; received an intravitreal injection of any other agent within four months prior to enrollment; prior vitrectomy.
Information: shimelk@nei.nih.gov

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 μm; well-demarcated GA due to AMD of total area 1.9-17 mm2; BCVA score of ≥55 letters.
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 Sub-retinal 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 μm of GA (as defined in the AREDS study) involving the central fovea; no evidence of current or prior CNV.
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 (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale).
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 (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy); uncontrolled hypertension (>150 systolic or >95 diastolic); diabetes mellitus; glaucoma.
Information: pralston@macuclear.com



WET AMD

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; 60 years of age or older; provides signed and dated informed consent; agrees to provide 10 mL of whole blood and two buccal swabs.
Exclusion Criteria: Previous donation under this protocol.
Information: jmcavinue@morriseyegroup.com

Study: Nexus: Efficacy and Safety Study of iSONEP With and Without Lucentis/Avastin to Treat Age-related Macular Degeneration
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 Age-related Macular Degeneration.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
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 (leakage on FA); presence of residual subretinal or intraretinal fluid on Cirrus SDOCT; SDOCT in the 1 mm central macular subfield on the retinal map analysis of ≥250 μm at screening.
Exclusion Criteria: Most recent IVT injection of Lucentis or Avastin fewer than 28 days and more than 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; use of IVT, subtenon or subconjunctival steroids 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 in the study eye; CNV must be at least 50% of total lesion size by either previous or current angiogram; ETDRS best-corrected visual acuity of: 20/25 to 20/320 (letter score of 73 to 25) in the study eye
Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins; prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study; presence of retinal pigment epithelial tears or rips involving the macula in the study; history of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye
Information: singhr@ccf.org

Study: Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (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-retinal pigment epithelium (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 “wet” AMD naïve to treatment, “wet” AMD patient treated with 4 or more monthly injections of anti-VEGF treatment without an adequate response (persistent fluid on OCT), or “dry” AMD, category 2 or 3 by AREDS (Age-Related Eye Disease Study) criteria.
Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma); previous AMD therapy; patients being treated for autoimmune or other disease with immunomodulatory drugs (i.e., prednisone, infliximab, methotrexate); patients with recent (less than 6 months) ocular or systemic surgery.
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 age-related macular degeneration.
Design: Randomized, Parallel Assignment, Single-blind, Treatment
Number of Patients: 57
Inclusion Criteria: Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye; an active choroidal neovascular membrane attributable to neovascular AMD in at least one eye; history of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.
Exclusion Criteria: History of recurrent nonresponse to anti-VEGF therapy in the study eye; in the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary); choroidal neovascularization due to a cause other than AMD; in the study eye, media opacity that, in the investigator’s opinion, could interfere with conduct of the study.
Information: (862) 778-8300

Study: TURF: Study for Recalcitrant Age-Related Macular Degeneration
Sponsor: Regeneron/Greater Houston Retina Research
Purpose: To study 50 patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5 mg and subsequently treated with ranibizumab 2.0 mg, who are incomplete responders to 2.0 mg of ranibizumab.
Design: Interventional, Efficacy, Single Group, Open Label, Treatment
Number of Patients: 50
Inclusion Criteria: Choroidal neovascularization secondary to AMD; history of treatment with 0.5 mg ranibizumab followed by 2.0 mg ranibizumab for AMD; best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS chart.
Exclusion Criteria: Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline; prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments; presence of significant subfoveal fibrosis or atrophy; prior treatment with intravitreal aflibercept injection.
Information: dmbmd@houstonretina.com

Study: Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration
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: Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-Eye.
Exclusion Criteria: Patients with any previous or concurrent history of treatment of other retinal diseases with pharmacologic agents other than ranibizumab, including verteporfin photodynamic therapy, bevacizumab, triamcinolone, or dexamethasone; patients with prior history of vitrectomy surgery in the study eye; patients enrolled in any previous or current clinical trial or study of any medication for AMD or any other retinal vascular disease, including diabetic retinopathy or retinal vein occlusion; ocular media opacity precluding proper retinal imaging.
Information: (650) 723-6995

Study: Addition of 20 mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age-Related Macular Degeneration
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 intravitreal bevacizumab (Avastin), intravitreal dexamethasone and PDT laser photocoagulation improves anatomic and visual outcome compared to patients not receiving oral Zeaxanthin.
Design: Observational, Case Control, Retrospective
Number of Patients: 200
Inclusion Criteria: Subjects must have age-related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye; preoperative best corrected visual acuity equal to or greater than 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen); media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment.
Exclusion Criteria: Evidence of diabetic retinopathy or other retinal disease other than age-related macular degeneration; any severe active ocular disease or condition that in the opinion of the investigator is severe enough to prevent a 3-line improvement in visual acuity or to compromise the study results; any presumed ocular infections, i.e., bacterial, viral, parasitic, or fungal in either eye at the baseline visit.
Information: rjolk@retina-stl.com

Study: Evaluation of AGN-150998 in Exudative Age-Related Macular Degeneration
Sponsor: Allergan
Purpose: To assess the safety of AGN-150998 administered as an intravitreal injection to patients with exudative age-related macular degeneration.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 200
Inclusion Criteria: Age-related macular degeneration; best-corrected visual acuity 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 Age-Related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab
Sponsor: UC, San Diego/Genentech
Purpose: To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA.
Design: Intervention, Safety/Efficacy, Singlegroup 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.
Exclusion Criteria: Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study); juxtafoveal and extrafoveal wet-AMD.
Information: CJL015@ucsd.edu

Study: ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
Sponsor: Alcon Research
Purpose: To evaluate the safety, tolerability and effects of an investigational drug ESBA1008 for the treatment of exudative age-related macular degeneration.
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 90
Inclusion Criteria: Primary subfoveal CNV secondary to AMD, including predominantly classic, minimally classic or occult lesions in study eye; a new diagnosis of exudative AMD or evidence of recent disease progression within the last 3 months in study eye.
Exclusion Criteria: Study eye must not have been treated for wet AMD previously; study eye must not have any other ocular disease, condition, infection or recent surgery that would interfere with vision or examination of the back of the eye; study eye must not have uncontrolled glaucoma and/or must not be missing a lens.
Information: (888) 451-3937

Study: Study of Dark Adaptation in Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry age-related macular degeneration.
Design: Observational, Prospective
Number of Patients: 200
Inclusion Criteria: Group 0: Participant without AMD defined as no large drusen or advanced AMD in either eye; Group 1: Participant has at least one large drusen (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye; Group 2: Participant has bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes; Group 3: Participant has at least one large drusen (greater than or equal to 125 microns) in the study eye and advanced AMD in the fellow eye.
Exclusion Criteria: Participant has advanced AMD (as defined in Appendix 1) in the study eye at the baseline visit; participant has other active ocular or macular diseases (eg, diabetic macular edema, retinal vein occlusion, Stargardt’s disease or cone-rod dystrophy) or other known ocular disorders that have caused a visual field deficit (eg, glaucoma with known visual field defect) in the study eye.
Information: prpl@mail.cc.nih.gov

Study: CFH&AMD: Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration
Sponsor: Department of Veterans Affairs
Purpose: To the hypothesis that smoking increases AMD by increasing complement activation; and that this is positively correlated with known disease variations in the complement factor H (CFH) gene.
Design: Observational, Cohort, Prospective
Number of Patients: 300
Inclusion Criteria: Inclusion criteria for subjects will be a clear diagnosis of AMD.
Exclusion Criteria: We will exclude individuals with ocular diseases that might simulate age-related macular degeneration or preclude its diagnosis.
Information: rohrer@musc.edu

Study: Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration
Sponsor: Johns Hopkins University
Purpose: To demonstrate that use of the test booklet leads to more rapid identification of newly developing vision problems, earlier diagnosis and treatment of incipient wet AMD that should result in fewer people losing their vision and less severe losses of vision.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Diagnostic
Number of Patients: 1000
Inclusion Criteria: Subjects with a confirmed diagnosis of AREDS grade 3 or 4 AMD in at least one eye will be recruited for components 1 and 2 of the study.
Exclusion Criteria: Subjects with vision loss due to ocular pathology other than AMD or cataracts will be excluded.
Information: gdagnelie@jhmi.edu

Study: GEM: Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (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 in the study eye.
Exclusion Criteria: Significant ocular abnormalities that prevent retinal assessment; treatment with steroids within three months of screening; treatment with anti-VEGF therapy to either eye 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: Visual acuity 20/40 to 20/400; lesion size < 12 Disc Area; submacular hemorrhage less than 75% of total lesion and not involving foveal center; submacular fibrosis less than 25% of total lesion.
Exclusion Criteria: Previous treatment with photodynamic therapy or thermal laser in study eye; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon’s Kenalog within 6 months.
Information: (916) 734-6074

Study: Pilot Study of X-82 in Patients With Wet AMD
Sponsor: Xcovery Vision, LLC/Tyrogenex
Purpose: To evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD).
Design: Interventional, Safety/Efficacy, Singlegroup Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography and OCT; no previous treatment with anti-VEGF therapy OR prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment; if present, subretinal hemorrhage < 50% of total lesion size; BCVA 20/40 to 20/200 or 20/320 in the study eye and the same or better in the fellow eye.
Exclusion Criteria: Previous treatment with photodynamic therapy (PDT), external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia; geographic atrophy involving the fovea in the study eye; any retinal vascular disease or retinal degeneration other than AMD in the study eye.
Information: brittanybrown@trialrunners.com



DIABETIC MACULAR EDEMA

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, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease; no media opacity precluding good retinal photography.
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; or previous intraocular injections for the treatment of diabetic retinopathy; a media opacity in either eye that is severe enough to preclude good retinal photography.
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 centralinvolved 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, Double-blind, 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; eye has retinal thickness in the central subfield on baseline OCT measurement greater than or equal to 330 microns, as measured by Cirrus OCT.
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 (e.g., 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 (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, etc.).
Information: wileyhe@mail.nih.gov

Study: Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
Sponsor: Allergan
Purpose: To compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 300
Inclusion Criteria: Diagnosis of macular edema; visual acuity between 20/200 to 20/40.
Exclusion Criteria: Eye surgery to the study eye within 3 months; use of Ozurdex within 9months; any active ocular inflammation and infection; diagnosis of glaucoma; use of anti-VEGF treatment within 3 months in the eye or systemic use within 6 months.
Information: clinicaltrials@allergan.com

Study: Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
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 diabetic macular edema.
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: iDEAL: Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of DME
Sponsor: Quan Dong Nguyen/Juvenile Diabetes Research Foundation/iCo Therapeutics, Inc.
Purpose: To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation.
Design: Interventional, Randomized, Safety/Efficacy, Factorial Assignment, Open Label
Number of Patients: 208
Inclusion Criteria: Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥ 5.5% and HbA1c ≥13%; have nonproliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period; have diabetic macular edema with central subfield thickness of ≥ 250 microns (confirmed by Stratus TD OCT) Have best corrected visual acuity (ETDRS) that is Snellen equivalent of 20/32 and ≥ 20/320, inclusive.
Exclusion Criteria: Have macular or perimacular edema secondary to an etiology other than diabetes; have concurrent retinal diseases other than diabetic retinopathy; have additional ocular diseases compromising visual acuity and/or interfering with study assessments.
Information: qnguyen4@jhmi.edu

Study: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Sponsor: Retina Macula Institute/Allergan
Purpose: To test the efficacy of an 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 ≥2 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, 200° 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 ≥ 300 μm; 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 4months prior to screening.
Information: dmbmd@houstonretina.com

Study: NSAID Phase II for Non-central Involved Diabetic Macular Edema
Sponsor: DRCR.net/National Eye Institute
Purpose: To assess the effects of topical NSAIDs onmacular retinal volume compared with placebo in eyes with non-central DME
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 120
Inclusion Criteria: BCVA of 20/32 or better within 8 days of enrollment; definite retinal thickening due to DME within 3000 μm of the center of the macula but not involving the central subfield; thickened non-central macular subfields on DRCR.net approved spectral domain OCT macular map.
Exclusion Criteria: Anticipated need to treat DME during the course of the study; history of use of NSAID eye drops within the last 30 days or anticipated need for such drops during the study due to other ocular condition; history of PRP within 4 months prior to randomization.
Information: aglassman@jaeb.org

► 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 or plan to do so.
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 Investigators will verify the laser therapy was performed for DME via medical records, FA or photographs.
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: Dextromethorphan for DME
Sponsor: NEI/NIH Clinical Center
Purpose: To see if dextromethorphan can help treat diabetic macular edema.
Design: Interventional, Safety/Efficacy, Singlegroup Assignment, Open Label, Treatment
Number of Patients: 8
Inclusion Criteria: VA between 20/32 and 20/200; definite retinal thickening due to DME involving the center of the macula 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.
Information: (800) 411-1222

Study: MATISSE: PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
Sponsor: Quark Pharmaceuticals
Purpose: To determine the maximum tolerated dose and any dose-limiting toxicities and to evaluate the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients with DME.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 264
Inclusion Criteria: History of diabetes mellitus (Type 1 or Type 2); retinal thickening secondary to the edema caused by diabetes mellitus; best corrected visual acuity (BCVA) of 20/40 or worse and up to 20/320 or better in the study eye at Screening; standard of care treatment for DME can be withheld for at least 90 days after the subject has enrolled in the study.
Exclusion Criteria: History of panretinal photocoagulation within 6 months or macular laser photocoagulation within 3 months of prior to dosing in the study eye; any IVT injection therapy performed in the study eye within 3 months prior to dosing; iris neovascularization, vitreous hemorrhage, tractional retinal detachment, vitreomacular traction, epiretinal membrane or preretinal fibrosis involving the macula in the study eye; history of IVT surgery in the study eye; prior intraocular surgery or corneal laser surgery, performed within 3 months prior to dosing in the study eye; received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing; high risk proliferative diabetic retinopathy (PDR) in the study eye. Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
Information: ishefer@quarkpharma.com



RETINAL VEIN OCCLUSION

Study: REVOLUTION: REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study
Sponsor: Retina Association of Florida, PA
Purpose: To compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 20
Inclusion Criteria: Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion.
Exclusion Criteria: Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months; previous scatter laser photocoagulation.
Information: ivansuner@gmail.com

Study: RELATE: Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Sponsor: Peter A. Campochiaro, MD/Genentech
Purpose: To evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to retinal vein occlusion.
Design: Interventional, Randomized, Safety, Parallel Assignment, Open Label, Treatment
Number of Patients: 80
Inclusion Criteria: Diagnosis of macular edema due to central or branch retinal vein occlusion; foveal thickness of equal to or greater than 250 mm, as assessed by OCT.
Exclusion Criteria: Scatter laser photoco agulation or macular photocoagulation within 3 months of study entry in the study eye; intraocular surgery in the study eye within 3 months of study entry; use of steroids within 4 months.
Information: ghafiz@jhmi.edu

Study: FAVOR: Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Sponsor: Alimera
Purpose: To assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment.
Number of Patients: 20
Inclusion Criteria: Diagnosis of macular edema due to BRVO OR CRVO
Exclusion Criteria: Macular edema secondary to any condition other than RVO; presence of foveal atrophy, dense pigmentary changes in the study eye.
Information: Kathleen.billman@alimerasciences.com

Study: Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to RVO
Sponsor: Wills Eye Institute
Purpose: To compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or central retinal vein occlusion.
Design: Randomized, Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Must be diagnosed within two weeks of onset of symptoms; BCVA between 20/40 and 20/320.
Exclusion Criteria: Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid laser.

Study: Comparison of Initial Ozurdex to Avastin for Treatment of Macular Edema Caused by CRVO
Sponsor: Long Island Vitreoretinal Consultants
Purpose: To compare visual improvement and total number of intraocular injections in eyes with macular edema following CRVO after initial treatment with Ozurdex or Avastin.
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 30
Inclusion Criteria: Presence of central retinal vein occlusion (CRVO); ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800.
Exclusion Criteria: History of glaucoma in the study eye with intraocular pressure > 21mmHg on >1 topical medication.
Information: (631) 234-5666

Study: Study to Assess the Clinical Efficacy and Safety of VEGF Trap-Eye (Intravitreal Aflibercept Injection), Also Commercially Known as EYLEA in Patients With BRVO
Sponsor: Regeneron
Purpose: To assess the efficacy and safety of VEGF Trap-Eye compared to laser in patients with macular edema secondary to BRVO.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 180
Inclusion Criteria: Foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months .
Exclusion Criteria: Current bilateral manifestation of BRVO; uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery.
Information: clinicaltrials@regeneron.com

Study: Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion
Sponsor: Weill Medical College of Cornell
Purpose: To investigate whether this intervention may reopen the central retinal vein and improve retinal blood flow.
Design: Interventional, Safety/Efficacy, Singlegroup Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Severe CRVO diagnosed on presence of relative afferent papillary defect or visual acuity of 20/200 or worse; symptom onset within 2 weeks.
Exclusion Criteria: Futile intervention: no light perception, absence of perfusion on fluorescein angiography; contra-indication to thrombolysis: active or recent (1 month) internal bleeding, cerebrovascular accident, major organ surgery.
Information: kas2004@med.cornell.edu

Study: WAVE: Targeted Laser With Lucentis 0.5mg Verses Lucentis 0.5mg Monotherapy for Ischemic Central Vein Occlusion
Sponsor: Genentech/Charles C. Wykoff, MD
Purpose: To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, compared to standard of care.
Design: Interventional, Randomized, Safety/Efficacy, Single Group Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Subjects with Ischemic Central Retinal Vein Occlusion with at least 2 consecutive monthly intravitreal injections of anti-VEGF medications with presence of persistent edema in the past 4 months.
Exclusion Criteria: IOP over 30 mm Hg Any previous retinal laser photocoagulation to the study eye; previous intravitreal injection in the study eye of any corticosteroid treatment.
Information: dmbmd@houstonretina.com

Study: Efficacy of an Intravitreal DEX Implant in RVO Following Treatment With Anti-VEGF Injections
Sponsor: Allergan/Retina Macula Institute
Purpose: To test the efficacy of a 0.7 mg intravitreal dexamethasone implant on macular function and recalcitrant macular edema associated with RVO following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Double-blind
Number of Patients: 10
Inclusion Criteria: Presence of CRVO or BRVO; prior treatment with ≥2 intravitreal anti-VEGF injections but no treatment in last 45 days.
Exclusion Criteria: History of steroid-related glaucoma requiring more than one topical glaucoma medication; intraocular injection of steroid medication within prior 4 months.
Information: natalie.truong@retinamaculainstitute.com

Study: Minocycline to Treat BRVO
Sponsor: National Eye Institute
Purpose: To test the safety and effectiveness of minocycline as a treatment for branch RVO.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 20
Inclusion Criteria: The study eye shows evidence of definite retinal thickening due to a BRVO based on clinical examination.
Exclusion Criteria: Participant is in another investigational study and actively receiving investigational product for BRVO.
Information: prpl@mail.cc.nih.gov

Study: CRAVE: Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
Sponsor: Barnes Retina Institute
Purpose: To measure the change in central retinal thickness after either treatment.
Design: Interventional, Randomized, Efficacy Study, Parallel Assignment, Single-blind, Treatment
Number of Patients: 150
Inclusion Criteria: Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD); central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below); diagnosis of retinal vein occlusion in the past 9 months.
Exclusion Criteria: History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery).
Information: (314) 367-1181

Study: Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion
Sponsor: California Retina Consultants/Genentech
Purpose: To determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with.
Design: Interventional, Randomized, Safety/Efficacy, Crossover Assignment, Open Label,
Number of Patients: 20
Inclusion Criteria: CRVO
Exclusion Criteria: Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
Information: (314) 367-1181



UVEITIS

Study: Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis
Sponsor: XOMA (US), LLC/Institut de Recherches Internationales Servier
Purpose: To evaluate the efficacy of gevokizumab in the treatment of active noninfectious intermediate, posterior, or panuveitis.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 300
Inclusion Criteria: Diagnosis of noninfectious intermediate, posterior, or panuveitis in at least one eye; active uveitic disease in at least one eye Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication.
Exclusion Criteria: Infectious uveitis and masquerade syndromes; isolated anterior uveitis; contraindication to mydriatics; history of allergic or anaphylactic reactions to monoclonal antibodies.
Information: nathr@xoma.com

Study: Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
Sponsor: Abbott
Purpose: To compare the safety and efficacy of adalimumab vs. placebo in subjects with inactive uveitis.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 250
Inclusion Criteria: Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis; subject that for >/= 28 days prior to the Baseline visit has inactive disease and is taking >/= 10 mg of oral prednisone to maintain this inactive state and fulfillment of all 3 of the following criteria based on the Investigator’s clinical judgment at the Screening and Baseline visits for both eyes: subject without active, inflammatory chorioretinal and/or inflammatory retinal vascular lesions.
Exclusion Criteria: Subject with isolated anterior uveitis; Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1) infection, Whipple’s disease, herpes zoster virus(HZV) and herpes simplex virus(HSV); subject with serpiginous choroidopathy; subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial; subject with intraocular pressure of >/= 25 mmHg and on >/= 2 glaucoma medications or evidence of glaucomatous optic nerve injury.
Information: andrea.byars@abbott .com

Study: SAVE: Sirolimus as Therapeutic Approach to Uveitis
Sponsor: Johns Hopkins University/MacuSight, Inc.
Purpose: To find out about the safety and effectiveness of the study drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of sirolimus, and yet to avoid the potential complications of systemic use of the drug.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assig nment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present , it must be less than the posterior component; sufficient inflammation to require systemic treatment and, based on the Investigator’s decision, warrants intravitreal or subconjunctival treatment; best-corrected (ETDRS) visual acuity of 20/40 to 20/400 (approximately 70 to 20 letters) in the study eye; bestcorrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).
Exclusion Criteria: Patients with bilateral uveitis who are receiving systemic immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus, or azathioprine) other than prednisone or other corticosteroids for the treatment of the uveitis, and the uveitis in the fellow eyes, in the opinion of the investigator, cannot be controlled with standard local therapies alone; any significant ocular disease that could compromise vision in the study eye.
Information: qnguyen4@jhmi.edu

Study: Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate
Sponsor: National Eye Institute
Purpose: To evaluate the safety and effectiveness of methotrexate injections as a treatment for macular edema associated with uveitis.
Design: Interventional, Safety/Efficacy, Single-group Assig nment, Open Label, Treatment
Number of Patients: 7
Inclusion Criteria: Participant has chronic macular edema secondary to non-infectious panuveritis posterior or intermediate uveitis in at least one eye (the study eye) that has: not been responsive to conventional immunosuppressive therapy in the past 3 months; or recurred while on conventional immunosuppressive therapy; participant has central macular thickness of greater than or equal to 270 microns in the study eye; participant has visual acuity of 20/400 or better.
Exclusion Criteria: Participant has evidence of infectious panuveritis posterior or intermediate uveitis in either eye; participant is expected to need ocular surgery in the study eye during the course of the trial; participant had intraocular surgery in the study eye within the past 90 days; participant had an injection of bevacizumab or ranibizumab within the past four weeks.
Information: patti.sherry@nih.gov

Study: SAKURA: Study Assessing Doublemasked Uveitis Treatment
Sponsor: Santen, Inc.
Purpose: To evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 500
Inclusion Criteria: Confirmed diagnosis of active uveitis; meet best corrected ETDRS visual acuity.
Exclusion Criteria: Uveitis of infectious etiology; suspected/confirmed central nervous system or ocular lymphoma; primary diagnosis of anterior uveitis; uncontrolled glaucoma; use of topical oculary medication; implanted device; significant ocular disease; lens/media opacities or obscured ocular media; intraocular surgery or treatments; capsulotomy; ocular or periocular infection.
Information: clinicaltrials@santeninc.com

Study: Safety, Tolerability and Efficacy of Intravitreal LFG316 in Patients With Multifocal Choroiditis and Panuveitis
Sponsor: Novartis
Purpose: To assess the safety, tolerability and effect of intravitreal LFG316 in patients with active Multifocal Choroiditis and Panuveitis
Design: Interventional, Randomized, Parallel Assignment, Open Label, Treatment
Number of Patients: 24
Inclusion Criteria: Active Multifocal Choroiditis and Panuveitis in the study eye; vitrifies in the study eye of 2+ or more (on Nussenblatt scale); visual acuity (ETDRS Method) of 60 letters or less in the study eye
Exclusion Criteria: Substantial abnormality in screening laboratory results or electrocardiogram; history of infectious uveitis or endophthalmitis in either eye; media opacity in the study eye that would interfere with study conduct.
Information: (212) 307-1122



Retinal Physician, Volume: 10 , Issue: January 2013, page(s): 68 - 75

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