intravitreal, VEGF Therapy, macula

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Article Date: 6/1/2012

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CLINICAL TRIAL UPDATE

CLINICAL TRIAL UPDATE

DRY AMD
Study: Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degen eration Including Geographic Atrophy
Sponsor: Pfizer
Purpose: To determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy
Design: Randomized, harmacokinetics, Single Group, Double-blind, Treatment
Number of Patients: 24
Inclusion Criteria: Diagnosis of dry age-related macular degeneration including unior multi-focal geographic atrophy without foveal involvement; best-corrected visual acuity of 20/50 or better in the study eye
Exclusion Criteria: Evidence of ocular disease other than advanced age-related macular degeneration or geographic atrophy in the study eye; history or diagnosis of exudative (wet) age-related macular degeneration, with subretinal or choroidal neovascular lesions in the study eye; presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervousm immune, or gastrointestinal system; requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve
Information: (800) 718-1021

Study: Sirolimus for Advanced Age-Related Macular Degeneration
Sponsor: National Eye Institute/NIH Clinical Center
Purpose: To determine if sirolimus can help prevent vision loss in people with geographic atrophy
Design: Interventional, Randomized, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 15
Inclusion Criteria: Participant must have at least disc area (approximately 1 mm2) of geographic atrophy compatible with age-related macular degeneration present in each eye. Geographic atrophy is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the retinal pigment epithelium, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The geographic atrophy in each eye must be able to be photographed in their entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements
Exclusion Criteria: Participant has any of the following: a) a history of macular laser, b) a history of photodynamic therapy (PDT), c) received an intravitreal injection of anti-VEGF agent for wet/exudative AMD at any point, and d) received an intravitreal injection of any other agent (not an anti-VEGF agent) within four months prior to study enrollment. Participants currently taking or who have previously taken AREDS vitamin supplementation are not excluded
Information: prpl@mail.cc.nih.gov

Study: Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Sponsor: GlaxoSmithKline
Purpose: To determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 162
Inclusion Criteria: Evidence of age-related macular degeneration confirmed by the presence of at least 1 druse ≥ 125 µm diameter; well-demarcated geographic atrophy due to age-related macular degeneration of total area 1.9-17 mm2 measured in the study eye; best-corrected visual acuity score of ≥ 55 letters (approximately 20/80 Snellen VA equivalent or better) in the study eye
Exclusion Criteria: Additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole; history of choroidal neovascularization in either eye; any previous treatment for age-related macular degeneration approved or investigational, 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 Age Related Macular Degeneration
Sponsor: Advanced Cell Technology
Purpose: To evaluate the effect of subretinal injection of human embryonic stem cell-derived retinal pigment epithelium cells in patients with dry age-related macular degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies of retinal pigment epithelium (RPE) cellular therapy
Design: Interventional, Safety, Single-group Assignment, Open Label
Number of Patients: 12
Inclusion Criteria: Clinical findings consistent with advanced dry age-related macular degeneration with evidence of one or more areas of > 250microns of geographic atrophy (as defined in the Age-Related Eye Disease Study [AREDS] study) involving the central fovea; GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA; no evidence of current or prior choroidal neovascularization
Exclusion Criteria: Presence of active or inactive choroidal neovascularization; presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than age-related macular degeneration; history of optic neuropathy
Information: schwartz@jsei.ucla.edu

Study: A Study of the Safety and Efficacy of CNTO2476 in Patients With Age-related Macular Degeneration
Sponsor: Centocor, Inc.

Purpose: To assess the effects (good and bad) of a therapy called CNTO 2476 for patients with age-related macular degeneration
Design: Interventional, Randomized, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: Not given
Inclusion Criteria: Patient is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures; confirmed diagnosis of bilateral geographic atrophy (GA) of the macula bilaterally caused by age-related macular degeneration
Exclusion Criteria: Evidence of other significant ophthalmologic disease; ocular hypertension; previous cell therapy other than blood components
Information: info1@veritasmedicine.com

Study: A Multi-Center Study of Reading Rehabilitation in Macular Disease
Sponsor: Department of Veterans Affairs
Information: pdgrant@uic.edu

Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy
Sponsor: Alimera Sciences
Information: lschulz@med.wayne.edu

WET AMD
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 0.5mg 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 0.5mg ranibizumab followed by 2.0mg 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 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 the fact that 20 milligrams per day of oral Zeaxanthin as a supplement to patients with CNV and exudative AMD undergoing combination therapy with in travitreal bevacizumab (Avastin), intravitreal dexamethasone and PDT laser photocoagulation and 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 to 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 diopters or more; history 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 pa tients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with optical coherence tomography
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: 12-Week Patient Study in Neovascular Age-related Macular Degeneration
Sponsor: GlaxoSmithKline
Purpose: To investigate the safety and efficacy of a single-dose regimen of pazopanib eye drop for neovascular AMD
Design: Efficacy, Single-group Assignment, Open Label, Treatment
Number of Subjects: 27
Inclusion Criteria: For each subject enrolled in the study, only one eye (study eye) will be treated, and eligibility criteria apply to the study eye. All of the following characteristics are required and must be confirmed by the central reading center: CNV caused by AMD that extends under the geometric center of the foveal avascular zone; center subfield thickness (inclusive of subretinal fluid) > 320 microns on OCT
Exclusion Criteria: Additional eye disease in the study eye that could compromise best-corrected visual acuity (eg, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, infection or retinitis pigmentosa); CNV in the study eye due to other causes unrelated to AMD; presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required)
Information: GSKClinicalSupportHD@gsk.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, Single-group Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others; patients that have lost > 5 letters from baseline best vision; BCVA 20/25-20/320
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 (AMD) 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 (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 or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; previous posterior vitrectomy or retinal surgery
Information: anowak@eyeboston.com

Study: IBI 20089+Lucentis Combo Intravitreal Injections for Treatment of Neovascular AMD (Icon Combo)
Sponsor: Univ. of Illinois/Icon Bioscience, Inc.
Purpose: To assess the safety and tolerability of an investigational drug called IBI-20089 (6.9 mg and 13.8 mg) when used adjunctively with Lucentis 0.5 mg in subjects with subfoveal neovascular AMD
Design: Interventional, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Diagnosis of active, subfoveal choroidal neovascular membranes due to age-related macular degeneration; visual acuity from 20/50 to 20/400 in the study eye
Exclusion Criteria: Subjects who have received corticosteroids via any route in the past 90 days; in the opinion of the investigator, patient at risk of elevated ocular pressure or is known to be a steroid-responder
Information: alcmalek@uic.edu

Study: A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD (Lucedex)
Sponsor: Bay Area Retina Associates
Purpose: To evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet AMD
Design: Randomized, Safety, Parallel Assignment, Single-blind, Supportive-care
Number of Patients: 40
Inclusion Criteria: All lesion subtypes will be enrolled with the following criteria: Predominantly and minimally classic: angiographic lesion greater than 50% of the total lesion area; occult: lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretina fluid
Exclusion Criteria: Previous treatment for AMD in the study eye; previous intravitreal drug delivery in the study eye; previous vitrectomy in the study eye
Information: lsray01@yahoo.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

Study: Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in AMD — Correlation With Lucentis Therapy (Antibody)
Sponsor: University of California–Davis/Genentech
Information: dgtelander@ucdavis.edu

Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Information: cawh@aol.com

Study: Antioxidant Systems and AMD
Sponsor: Vanderbilt University/National Institutes of Health.
Information: paul.sternberg@vanderbilt.edu

Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet AMD
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

DIABETIC MACULAR EDEMA
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 9 months; any active ocular inflammation and infection; diagnosis of glaucoma; use of anti-VEGF treatment (eg, Lucentis®) within 3 months in the eye or systemic use (eg, Avastin®) 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 in study eye within last 6months; 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 Diabetic Macular Edema
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, Treatment
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 non-proliferative 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; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study
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 (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 20
Inclusion Criteria: Presence of NPDR or PDR as confirmed by fluorescein angiography; prior treatment with ≥ 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks; < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with ≥ 2 intravitreal anti-VEGF injections
Exclusion Criteria: Intraocular injection of steroid medication within prior 3 months; evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician; concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
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 Research
Purpose: To study the efficacy and safety of ranibizumab injection monotherapy verses a duel therapy of 0.5mg ranibizumab combined with ultra wide, 200° field angiography guided pan retinal photocoagulation in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2)
Design: Interventional, Randomized, Safety/Efficacy, Single Group, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: BCVA score in the study eye of 20/32 to 20/200 approximate snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator; high Definition OCT (Spectralis) central thickness measurement of ≥ 300µm; decrease in visual acuity is determined to be primarily the result of DME and not to other cause
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, PC/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 microns 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 > 180/110 (systolic above 180 OR diastolic above 110); any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
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, Treatment
Number of Patients: 120
Inclusion Criteria: Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 or better) within 8 days of enrollment; on clinical exam, 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 panretinal (scatter) photocoagulation (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 treating diabetic retinal swelling with 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; patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40; central foveal thickness on SD-OCT of >300 µm
Exclusion Criteria: Intraocular surgery less than 6 months ago; epiretinal membrane 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 (NIR) therapy on anatomic and functional abnormalities of diabetic macular edema as assessed by visual acuity, optical coherence tomography, multi-focal electroretinography (mERG) and fundus bimicroscopy
Design: Interventional, Non-randomized, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Fellow eye meets criteria; any candidate identified by a study investigator as being 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 (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled; participation in an investigational trial within 30 days of NIR participation that involved treatment with any drug that has not received regulatory approval at the time of study entry
Information: hwhelan@mcw.edu

Study: Evaluation of Single Nucleotide Polymorphisms (SNPs) in Patients With and Without Diabetic Macular Edema
Sponsor: National Eye Institute/NIH Clinical Center
Purpose: To investigate genetic factors that may influence the development of diabetic macular edema
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, fluorescein angiograms or photographs
Exclusion Criteria: Participant has another retinal disease that may confound the evaluation of the DME. Examples include vein occlusions, uveitic macular edema or neovascular age-related macular degeneration; participant has opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate dilated examination
Information: (800) 411-1222

Study: Dextromethorphan for Diabetic Macular Edema
Sponsor:National Eye Institute/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: Best-corrected ETDRS visual acuity score between 78 and 39 letters (i.e., between 20/32 and 20/200); definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula that is not refractory to further therapy as based on the investigator's clinical judgment
Exclusion Criteria: An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (eg, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition)
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 an anti inflammatory anti metabolite at low concentrations in diabetic patients with macular edema who have failed conventional FDA approved and well studied off label therapies that involve laser and/or intravitreal drugs
Design: Interventional, Nonrandomized, Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 10
Inclusion Criteria: Optical coherence tomography (OCT) scan demonstrating more than 275 microns retinal thickness in central subfield of study eye; ability to understand study instructions, interventions and potential complications
Exclusion Criteria: An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense sub foveal hard exudates, nonretinal condition)
Information: lcooke@wakehealth.edu

Study: READ 3:Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose
Sponsor: Johns Hopkins/Juvenile Diabetes Research Foundation
Information: jdenton2@jhmi.edu

RETINAL VEIN OCCLUSION
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 microns
Exclusion Criteria: History of glaucoma in the study eye with intraocular pressure > 21mmHg 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 (bevacizu-mab) 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 Commer cially 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 mmHg 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 treatment naïve
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 Fol lowing 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, Treatment
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; ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800; central foveal thickness >275 microns 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 fluorescein angiography in the opinion of the treating physician; 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 (e.g., unstable medical status including blood pressure and glycemic control).
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, Treatment
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 as based on the investigator's clinical judgment. CRVO is de fined as an eye that had retinal hemorrhage or other biomicroscopic evidence of RVO (e.g., telangiectatic capillary bed) and a dilated (or previously dilated) venous system in at least three quadrants 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 (e.g., unstable medical status including blood pressure and glycemic control)
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), within 60 days of the screening visit; inability to make study visits; uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological antiglaucomatous medications)
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 (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion 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. A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. 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 microns 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 (presence of ischemic CRVO/BRVO); evidence of central atrophy or fibrosis in the study eye; presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study
Information: jgasperini@gmail.com

Study: Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion From Vein Occlusion
Sponsor: California Retina Consultants/Genentech
Purpose: To determine whether ranibizumab (Lucentis) will be effective in reducing if not eliminating the macular edema associated with the disease CRVO
Design: Interventional, Randomized, Safety/Efficacy, Crossover Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Clinical evidence of perfused CRVO. A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. 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, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema
Information: (314) 367-1181


Retinal Physician, Volume: 9 , Issue: June 2012, page(s): 64 - 70

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