intravitreal, VEGF Therapy, macula

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Article Date: 9/1/2012

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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: A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With GA Associated With Age-Related Macular Degeneration
Sponsor: Alcon
Purpose: To evaluate the safety and efficacy of 12 monthly IVT injections of µg of AL-78898A, a C3 inhibitor, in slowing down the rate of progression from base line, of GA lesion size in patients diagnosed with GA associated with AMD.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind.
Number of Patients: 120
Inclusion Criteria: Diagnosis of GA of the macula caused by AMD, confirmed within 14 days prior to randomization by the central reading center using FAF images, as well as the following criteria: total GA area in study eye must be of size 1.25-20 mm2; GA in the study eye can be completely visualized on the macula centered image; GA must be able to be photographed in its entirety and not contiguous with any areas of peripapillary atrophy.
Exclusion Criteria: Any history or current evidence of exudative AMD in study eye including any evidence of RPE rips or evidence of neovascularization anywhere in the retina; retinal disease other than AMD.
Information: (888) 451-3937

► 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 at least one large druse (≥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 4 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

WET AMD
► 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 rani-bizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg 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, triam-cinolone, 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 20mg/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 (BCVA) 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 8.00D 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: Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular Age-Related Macular Degeneration
Sponsor: Notal Vision, Ltd.
Purpose: To evaluate if, in post-treatment patients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with OCT.
Design: Observational, Cohort, Prospective.
Number of Patients: 120
Inclusion Criteria: Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study; last diagnosis was, and current diagnosis is, no CNV activity in SE eye; current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in SE; presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy; any non-macular related ocular surgery performed within 3 months prior to study entry in SE.
Information: (410) 686-3000

► 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, Single Group Assignment, Open Label, Treatment.
Number of Patients: 40
Inclusion Criteria: Naive 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-b0lind, 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: Individuals with ocular diseases that might simulate age-related macular degenerationor 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.
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, Doubleblind, Treatment.
Number of Patients: 45
Inclusion Criteria: Visual acuity 20/40 to 20/400; lesion size < 12 dsc 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 (PDT) 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: Phase I Study of Palomid 529, a Dual TORC1/2 Inhibitor of the PI3K/Akt/m TOR Pathway for Advanced Neovascular AMD (P52901)
Sponsor: Paloma Pharmaceuticals, Inc.
Purpose: To determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally.
Design: Interventional, Uncontrolled, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 33
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/100 and 20/800 (between 53 and 4 ETDRS letters read), and better or equal to 20/200 (minimum of 34 letters read) in the fellow eye.
Exclusion Criteria: Any retinovascular disease orretinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; previous posterior vitrectomy or retinal surgery.
Information: anowak@eyeboston.com

► Study: Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Sponsor: Genzyme
Information: medinfo@genzyme.com

► Study: Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration (AMD)
Sponsor: UCLA/ThomboGenics
Information: ostrick@jsei.ucla.edu

DIABETIC MACULAR EDEMA
► 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, Singleblind, 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: GUARDIAN: A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema
Sponsor: Retinal Institute of Hawaii/Eyetech
Purpose: To establish the efficacy of initial high frequency loading of intravitreal pegaptanib biweekly during the initial treatment period when the VEGF levels are the greatest and then gradually extending the administration frequency to monthly as homeostasis ensues for the treatment of DME, as measured by BCVA.
Design: Expanded Access.
Inclusion Criteria: Vision of 20/40-20/400; DME as documented by SD-OCT and FA0
Exclusion Criteria: Eyes in which retinal surgery is needed now or likely to be needed within 6 months; any abnormality that is likely to confound assessment of VA improvement in eyes in which macular edema resolves, or improves; ERM associated with signs of contraction and/or significant opacification, or presence of chorioretinal atrophy involving the center of the macula.
Information: mikebennett@retinahawaii.com

► 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; 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 Dexame-thasone 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, Singleblind, 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 9 months; 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: MATISSE: PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema
Sponsor: Quark Pharmaceuticals
Purpose: To determine the maximum tolerated dose and any dose-limiting toxicities of PF-0423655.
Design: 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.
Exclusion Criteria: History of vitrectomy; history of IVT injection within last 6 months; history of vitreous hemorrhage, retinal detachment, or invasive trauma in study eye.
Information: ishefer@quarkpharma.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-7 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 pm (confirmed by Stratus TD OCT); have best-corrected visual acuity (ETDRS) that is Snellen equivalent of 20/32 and ≥ 20/320.
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 ultra wide, 200° field angiography guided pan retinal 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 pan retinal photocoagulation in the study eye; prior treatment with intraocular or subconjunctival steroids in the study eye 4 months prior to screen.
Information: dmbmd@houstonretina.com

► Study: Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
Sponsor: Vitreo-Retinal Associates/Genentech
Purpose: To confirm that the investigational drug ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema.
Design: Interventional, Randomized, Safety/Efficacy/Parallel Assignment, Open Label, Treatment.
Number of Patients: 20
Inclusion Criteria: Residual edema as determined by mean foveal thickness on Cirrus OCT > 300 µm and leakage seen on FA at baseline; clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy; previous history of at least 4 or more consecutive anti-VEGF intravitreal injections of pegaptanib sodium or bevacizumab (consecutive injections administered no more than 6 weeks apart in the last year) for the treatment of diabetic macular edema
Exclusion Criteria: Systemic use of anti-VEGF within 3 months prior to day 0; previous intravitreal ranibizumab within 3 months prior to day 0; blood pressure greater than 180/110.
Information: mlampson@retina-docs.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 on macular 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 µm 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, Single Group 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: Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies
Sponsor: Wake Forest University
Purpose: To evaluate the efficacy of MTX at low concentrations in diabetic patients with macularedema who have failed conventional FDA-approved and well-studied off-label therapies that involve laser or intravitreal drugs.
Design: Interventional, Nonrandomized, Efficacy, Single Group Assignment, Open Label.
Number of Patients: 10
Inclusion Criteria: OCT scan demonstrating more than 275 µm retinal thickness in central subfield.
Exclusion Criteria: An ocular condition such that VA loss would not improve from resolution of macular edema
Information: lcooke@wakehealth.edu

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, Singleblind, 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 on ultra-wide.field fluorescein angiography, absence of macular traction on clinical exam, UWFA, and OCT.
Exclusion Criteria: Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months; previous macular or panretinal scatter laser photocoagulation; previous pars plana vitrectomy.
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; best-corrected visual acuity score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled.
Exclusion Criteria: Scatter laser photocoagulation 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 intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry.
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 branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); central subfield thickness >300 m; BCVA of o •24 and o •68 letters.
Exclusion Criteria: Macular edema secondary to any condition other than RVO; presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye; cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss.
Information: Kathleen.billman@alimerasciences.com

► Study: Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion
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 on initial presentation between 20/40 and 20/320; no contraindications to intravitreal injection of dexamethasone implant or ranibizumab; central foveal thickness greater than 250 m on spectral domain-OCT.
Exclusion Criteria: Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid laser; patients with diabetic retinopathy; patients with age-related macular degeneration; patients with an optic neuropathy.

► Study: Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
Sponsor: Long Island Vitreoretinal Consultants
Purpose: To compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO) after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
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; OCT Central foveal thickness >250 µm.
Exclusion Criteria: History of glaucoma in the study eye with intraocular pressure > 21 mm Hg on more than one topical medication. Combination drugs are considered more than one medication; history of steroid-related glaucoma (steroid response); previous intraocular injection of steroid medication within 90 days; Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days.
Information: (631) 234-5666

► Study: Study to Assess the Clinical Efficacy and Safety of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]), Also Commercially Known as EYLEA™ in Patients With Branch Retinal Vein Occlusion (BRVO)
Sponsor: Regeneron
Purpose: To assess the efficacy and safety of VEGF Trap-Eye compared to laser treatment in patients with macular edema secondary to BRVO.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment.
Number of Patients: 180
Inclusion Criteria: Foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit; ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1.
Exclusion Criteria: Current bilateral manifestation of BRVO; uncontrolled glaucoma defined as ≥25 mm Hg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye; insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves).
Information: clinicaltrials@regeneron.com

► Study: Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion
Sponsor: Weill Medical College of Cornell University
Purpose: To investigate whether this intervention may reopen the central retinal vein and improve retinal blood flow.
Design: Interventional, Safety/Efficacy, Single Group Assignment, Open Label, Treatment.
Number of Patients: 5
Inclusion Criteria: Severe CRVO diagnosed on presence of relative afferent papillary defect (RAPD) 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, major trauma; intracranial neoplasm or vascular malformation, known bleeding diathesis, severe uncontrolled arterial hypertension, pregnancy (women of childbearing age must have a negative serum pregnancy test).
Information: kas2004@med.cornell.edu

► Study: RAVE2: Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion
Sponsor: Genentech/Greater Houston Retina Research
Purpose: To study intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or are treatment naive.
Design: Interventional, Nonrandomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment.
Number of Patients: 20
Inclusion Criteria: VA 20/200 or worse; RAPD 0.9 LU or worse; loss of 1-2e isopter on Goldmann Visual field (Kwon et al. 2001); ERG demonstrating b wave amplitude less than 60% of A wave; capillary nonperfusion greater than 50 DA.
Exclusion Criteria: IOP over 30 mm Hg; any previous retinal laser photocoagulation to the study eye in treatment naive; any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
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 (Ozurdex) on macular function and recalcitrant macular edema associated with retinal vein occlusion 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; VA of 20/25 to 20/800; central foveal thickness >275 µm or presence of cystic edema on OCT studies
Exclusion Criteria: History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication; intraocular injection of steroid medication within prior 4 months; evidence of significant retinal ischemia on FA; previous laser photocoagulation within 4 months of study
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 retinal vein occlusion.
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment.
Number of Patients: 20
Inclusion Criteria: The study eye shows evidence of definite retinal thickening due to a branch retinal vein occlusion based on clinical examination involving the center of the macula that is not refractory to further therapy as based on the investigator's clinical judgment. BRVO is defined as an eye that had retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g., telangiectatic capillary bed) and a dilated (or previously dilated) venous system in one or two quadrants or less of the retina drained by the affected vein.
Exclusion Criteria: Participant is in another investigational study and actively receiving investigational product for BRVO; participant is unable to comply with study procedures or follow-up visits; participant has a known hypersensitivity to sodium fluorescein dye; participant has a condition that, in the opinion of the investigator, would preclude participation in the study.
Information: prpl@mail.cc.nih.gov

► Study: Minocycline to Treat Central RVO
Sponsor: National Eye Institute
Purpose: To test the safety and effectiveness of minocycline as a treatment for branch retinal vein occlusion..
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind.
Number of Patients: 20
Inclusion Criteria: Study eye shows definite retinal thickening due to a CRVO based on clinical exam involving the center of the macula that is not refractory to further therapy.
Exclusion Criteria: Participant is in another investigational study and actively receiving investigational product for BRVO; participant is unable to comply with study procedures or follow-up visits; participant has a known hypersensitivity to sodium fluorescein dye.
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.
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) greater than 250 µm 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), within 60 days of the screening visit; inability to make study visits; uncontrolled glaucoma.
Information: (314) 367-1181

► Study: RAVEN: Intravitreal ranibizumab 0.5 mg, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab
Sponsor: Genentech
Purpose: To examine two doses of Ranibizumab (0.5 mg and 1.0 mg) for the treatment of macular edema secondary to RVO in patients that have previously failed treatment with other macular edema treatments including bevacizumab.
Design: Interventional, Randomized, Parallel Assignment, Open Label, Treatment.
Number of Patients: 20
Inclusion Criteria: For CRVO, clinical evidence of perfused central retinal vein occlusion; other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head; central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness > 300 µm after at least 3 months of bevacizumab or steroid therapy.
Exclusion Criteria: Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gass); evidence of neovascularization of the iris or retina; evidence of central atrophy or fibrosis in the study eye; presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision.
Information: jgasperini@gmail.com

► Study: Lucentis for Macular Edema Associated With CRVO
Sponsor: Calif. Retina Consultants/Genentech
Purpose: To determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with CRVO.
Design: Interventional, Randomized, Safety/Efficacy, Crossover Assignment, Open Label.
Number of Patients: 20
Inclusion Criteria: Clinical evidence of perfused CRVO; other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
Exclusion Criteria: Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema; an eye that has no chance of improving in VA following resolution of macular edema.
Information: (314) 367-1181

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