Article Date: 1/1/2012

Clinical Trial Update

Clinical Trial Update

DRY AMD
► 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 GA compatible with AMD present in each eye. GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, 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 GA 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 AMD confirmed by the presence of at least 1 druse ≥ 125 µm diameter; well-demarcated GA due to AMD 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 CNV in either eye; any previous treatment for AMD 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 AMD 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 CNV; presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than AMD; history of optic neuropathy
Information: schwartz@jsei.ucla.edu

► Study: A Study of the Safety and Efficacy of CNTO2476 in Patients With Agerelated 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

► Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration
Sponsor: Ocular Transplantation; National Neurovision Research Institute
Information: nradtke@rvrc.com

WET AMD
► 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: Near-sightedness 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 DegenerationHome Vision Monitoring Using the
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 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 nonmacular 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 bestcorrected 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 age-related macular degeneration; 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: Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
Sponsor: Alcon Research
Purpose: To assess whether AL-78898A, 5.25 mg is able to delay the need for reinjection in patients with exudative AMD
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 110
Inclusion Criteria: Presence of active juxtaor subfoveal choroidal neovascularization secondary to AMD; central subfield macular thickness of >315 µm as assessed by SD-OCT; diagnosis of AMD within the previous 12 months with no fewer than 3 and no more than 12 Lucentis® or Avastin® treatments
Exclusion Criteria: History or current evidence of macular or retinal disease in the study eye other than exudative AMD; any evidence of fibrosis or scarring within the CNV lesion in the study eye; any evidence of vitreous hemorrhage in the study eye
Information: (888) 451-3937

► Study: COMPASS: Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab
Sponsor: University of California, San Diego/Genentech
Purpose: To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA
Design: Intervention, Safety/Efficacy, Singlegroup Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others; patients that have lost >5 letters from baseline best vision; BCVA 20/25-20/320
Exclusion Criteria: Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study); juxtafoveal and extrafoveal wet-AMD
Information: CJL015@ucsd.edu

► Study: ESBA1008 Safety, Tolerability and Effects in Wet Age-related Macular Degeneration (AMD) Patients
Sponsor: Alcon Research
Purpose: To evaluate the safety, tolerability and effects of an investigational drug ESBA1008 for the treatment of exudative age-related macular degeneration
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 90
Inclusion Criteria: Primary subfoveal choroidal neovascularization (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 age-related macular degeneration (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 age-related macular degeneration (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: iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
Sponsor: Lpath/Pfizer
Purpose: To evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
Design: Randomized, Safety/Efficacy, Interventional, Single-group Assignment, Open Label, Treatment
Number of Patients: 32
Inclusion Criteria: Serous and/or fibrovascular PED secondary to exudative AMD or secondary to PCV (confirmed by SDOCT, FA and ICG) that has not demonstrated at least a 25% decrease in the height of the PED (from the onset of anti-VEGF therapy) following a minimum of 3 doses of an anti-VEGF agent
Exclusion Criteria: Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
Information: jada@crmd.net

► Study: Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
Sponsor: Steba Biotech S.A.
Purpose: To evaluate the safety (first objective) and efficacy (second objective) of an experimental drug product, Stakel®, in the treatment of neovascular AMD. The drug product is activated in patients by exposure to light at a specific wavelength (“Vascular Targeted Photodynamic therapy,” “VTP”)
Design: Interventional, Safety/Efficacy, Singlegroup, Open Label, Treatment
Number of Patients: 18
Inclusion Criteria: Twenty eight days or more after at least one ranibizumab injection, re current leakage on FA from subfoveal CNV (ie, CNV previously diagnosed and treated with antivascular endothelial growth factor (VEGF) therapy resulting in resolution of leakage or optical coherence tomography (OCT) thickening but currently presenting with new fluoresce in leakage from CNV associated with OCT thickening) secondary to AMD
Exclusion Criteria: Permanent structural damage to the center of the fovea of the study eye, or a concurrent ocular or systemic condition that could contraindicate admin istration of an investigational drug, Stakel® Solution, or fluorescein, affect interpretation of study results, or render the subject at a high risk of treatment complications
Information: ascott28@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 age-related macular degeneration
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: Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
Sponsor: Novartis
Purpose: To assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration
Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Male or female AMD patients 55 to 90 years old, inclusive; in either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
Exclusion Criteria: Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study; choroidal neovascularization due to a cause other than AMD
Information: jminer@retinalconsultantsaz.com

► Study: Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy (FVF4193s)
Sponsor: New York Eye & Ear Infirmary/Genentech
Purpose: To accurately measure anatomic re sponse to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy
Design: Interventional, Active Control, Safety/Efficacy, Single Group, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320; subfoveal choroidal neovascularization
Exclusion Criteria: Had ocular surgery within the past 60 days in the study eye; had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye; has intraocular pressure >25 mm Hg in the study eye
Information: ktai@nyee.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 pro ton 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 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: HiPED: High-Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration
Sponsor: Pacific Eye Associates/Genentech
Purpose: To evaluate the efficacy and safety of 2 mg ranibizumab, specifically for patients with fibrovascular PEDs that have not resolved follow ing at least 6 consecutive injections of ranibizumab or bevacizumab over the previous 12 months
Design: Interventional, Randomized, Dose Comparison, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Active or recurrent neovascular age-related macular degeneration involving the fovea on FA; presence of persistent fibrovascular pigment epithelial detachment on OCT following a minimum of 6 previous treatments in previous 12 months with ranibizumab and/or bevacizumab
Exclusion Criteria: Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy; previous sub foveal focal laser photocoagulation involving the foveal center
Information: pearesearch@yahoo.com

► 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, Singlegroup Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Diagnosis of active, subfoveal choroidal neovascular membranes due to agerelated 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: LAST: A Pilot Study to evaLuate the Role of High-dose rAnibizumab (2.0mg) in the Management of AMD in Patients With perSistent/recurrenT Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy
Sponsor: Vitreous-Retina-Macula Consultants of New York
Purpose: To compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy
Design: Interventional, Randomized, Efficacy Study, Parallel Assignment, Single-blind, Treatment
Number of Patients: 30
Inclusion Criteria: Subfoveal neovascularization secondary to AMD; BCVA in the study eye between 20/30 to 20/400 using an ETDRS chart; documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy
Exclusion Criteria: Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL; prior treatment with triamcinolone in the study eye within six months of BSL; prior treatment with dexamethasone in the study eye within 30 days prior to BSL
Information: pguerrero@vrmny.com

► 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 subretinal 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: University of California-Los Angeles/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: NSAID Phase II for Non-central Involved Diabetic Macular Edema
Sponsor: DRCR.net/National Eye Institute
Purpose: To assess the effects of topical nonsteroidal anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with non-central DME
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Doubleblind, 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: VISTA DME: Study of Intravitreal Administration of VEGF Trap-Eye (BAY86-5321) in Patients With Diabetic Macular Edema
Sponsor: Regeneron
Purpose: To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Doubleblind, Treatment
Number of Patients: 402
Inclusion Criteria: Decrease in vision determined to be primarily the result of DME in the study eye; BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria: aser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1; previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1; previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
Information: clinicaltrials@regeneron.com

► 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, multifocal 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, Singlegroup 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 (e.g., 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 ther apies 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 subfoveal hard exudates, nonretinal condition)
Information: lcooke@wakehealth.edu

► Study: Phase II Study of Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation
Sponsor: Michael J. Jumper, MD; Genentech

► 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

► Study: Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy
Sponsor: Fovea Pharmaceuticals SA
Information: contact-us@sanofi-aventis.com


Retinal Physician, Volume: 9 , Issue: January 2012, page(s): 73 - 75