CLINICAL TRIAL UPDATE

DRY AMD

Study: Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration

Sponsor: Bioheart, Inc.

Purpose: To evaluate the treatment of dry AMD with adipose stem cell implantation

Design: Interventional, Single Group, Open Label

Number of Patients: 100

Inclusion Criteria: Dry AMD; VA in the study <20/200

Exclusion Criteria: Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study; inability to undergo syringe liposuction procedure

Information: kcomella@bioheartinc.com

Study: NEAMD: Non-exudative Age-related Macular Degeneration

Sponsor: Oregon Health and Science University

Purpose: To use OCT technology to compare how the retinal anatomy and blood flow differ within three severity groupings of non-exudative AMD

Design: Observational, Case Control, Prospective

Number of Patients: 20

Inclusion Criteria: Presence of mild, moderate or severe NEAMD; media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs; vision better than 20/200

Exclusion Criteria: Inability to maintain stable fixation for OCT imaging. A condition that, in the opinion of the investigator, would preclude participation in the study; a concurrent ocular pathology that may contribute to vision loss

Information: (503) 494-3000

Study: I-TEAM: Intervention Trial in Early Age-related Macular Degeneration

Sponsor: Newtricious R&D BV

Purpose: To assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of AMD

Design: Randomized, Efficacy, Parallel Assignment, Double-blind

Number of Patients: 120

Inclusion Criteria: Many small drusen, or a few intermediate-sized (63-124 micrometers in diameter) drusen, or macular pigmentary changes

Exclusion Criteria: Ocular media opacity (severe cataract); history of active small bowel disease or resection; atrophic gastritis; hyperlipidemia (LDL >120 mg/dL or triglycerides >400 mg/dL)

Information: ian.j.murray@manchester.ac.uk

Study: Study on Visual Function Impairments in Dry Age-related Macular Degeneration

Sponsor: Duke University

Purpose: To submit enrollees to the visual function testing

Design: Observational, Prospective

Number of Patients: 190

Inclusion Criteria: Has been diagnosed with dry AMD stages 1-3

Exclusion Criteria: Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD

Information: (919) 684-9010

Study: Safety and Tolerability of Subretinal Transplantation of hESC-derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry AMD

Sponsor: Advanced Cell Technology

Purpose: To evaluate the effect of subretinal injection of human embryonic stem cell-derived RPE cells in patients with dry AMD and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies of RPE cellular therapy

Design: Interventional, Safety, Single Group Assignment, Open Label

Number of Patients: 12

Inclusion Criteria: Advanced dry AMD with evidence of one or more areas of > 250 microns of GA involving the central fovea

Exclusion Criteria: Presence of active or inactive CNV; presence or history of other retinal vascular or degenerative disease other than AMD; history of optic neuropathy

Information: schwartz@jsei.ucla.edu

Study: Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration

Sponsor: Alcon Research

Purpose: To evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced AMD

Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Basic Science

Number of Patients: 24

Inclusion Criteria: Diagnosis of AMD in study eye, as specified in protocol; poor VA in study eye, as specified in protocol; willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment

Exclusion Criteria: Treatments to the study eye within 28 days prior to study treatment, as specified in protocol; any disease or medication expected to cause systemic or ocular immunosuppression

Information: alcon.medinfo@alcon.com

Study: Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry AMD

Sponsor: Acucela, Inc.

Purpose: To characterize emixustat hydrochloride pharmacokinetic and pharmacodynamic parameters in subjects with GA associated with dry AMD

Design: Randomized, Pharmacokinetics/Dynamics, Crossover, Double-blind

Number of Patients: 26

Inclusion Criteria: Clinical diagnosis of GA associated with AMD

Exclusion Criteria: GA associated with a condition other than AMD; history of, active or high risk of developing CNV in either eye; known serious allergy to the fluorescein sodium for injection in angiography

Information: clinicaltrials@acucela.com

DRY AMD

Study: Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating Dry Age-Related Macular Degeneration

Sponsor: MacuCLEAR, Inc.

Purpose: To assess the efficacy, safety, and tolerability of MC-1101 for these patients

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 60

Inclusion Criteria: 20/80 or better ETDRS best corrected visual acuity; early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study [AREDS] Report No. 8 AMD Categories

Exclusion Criteria: Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories); past or current retinal or choroidal vasculopathy in study eye (eg serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy)

Information: pralston@macuclear.com

Study: BEACON: A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

Sponsor: Allergan

Purpose: To assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 300

Inclusion Criteria: Geographic atrophy due to age-related macular degeneration in the study eye; visual acuity better than or equal to 20/62 in the study eye and 20/200 in the fellow eye

Exclusion Criteria: Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months; infections in either eye in the last 3 months

Information: clinicaltrials@allergan.com

Study: Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (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 age-related macular degeneration

Design: Safety/Efficacy, Single Group, Open Label

Number of Patients: 16

Inclusion Criteria: Diagnosis of age-related macular degeneration with geographic atrophy (GA); only patients with a specific degree and extent of GA will be eligible; subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the study eye will be enrolled in Cohort I; subjects with BCVA of 20/320 to 20/100 in the study eye will be enrolled in Cohort II; no prior or current choroidal neovascularization in either eye

Exclusion Criteria: Prior vitreal or retinal surgery; glaucoma; atrophic macular disease of any other cause; diabetic retinopathy or diabetic macular edema in either eye; previous organ, tissue or bone marrow transplantation; previous participation in a gene transfer or a cell transplant trial; autoimmune disease; allergy to tacrolimus, mycophenolate mofetil (MMF), scopolamine, Cyclogyl, Moxifloxacin, or Gatifloxacin

Information: aaron.ilan@stemcellsinc.com

WET AMD

Study: First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration

Sponsor: Alcon Research

Purpose: To assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies

Design: Interventional, Randomized, Parallel Assignment, Double-blind

Number of Patients: 88

Exclusion Criteria: Any currently active ocular condition that requires use of topical eye drops; use of contact lens over the course of the study; abnormal corneal examination results at screening or

Information: alcon.medinfo@alcon.com

Study: Liberty: Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration

Sponsor: Retinal Consultants of Arizona/Genentech

Purpose: To reduce the burden of in office visits and injections

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label

Number of Patients: 60

Inclusion Criteria: Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient’s medical history and a documented diagnosis of CNV; the study eye must have received at least 3 anti-Vascular endothelial growth factor (VEGF) treatments prior to the screening visit, with at least 2 anti-VEGF treatments over the preceding 3 months; best-corrected VA (BCVA) of 20/32 to 20/200 Snellen equivalent in the study eye

Exclusion Criteria: Choroidal neovascu-larization in the study eye due to any reason other than AMD; active uncontrolled glaucoma; had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of enrollment

Information: RMcKusick@retinalconsultantsaz.com

Study: A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration

Sponsor: Santen Inc.

Purpose: To assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative AMD

Design: Interventional, Nonrandomized, Safety/Efficacy, Single Group, Open Label

Number of Patients: 9

Inclusion Criteria: Diagnosis of chronic subretinal or intraretinal fluid secondary to exudative AMD in the study eye; at least one lesion in the study eye that meets minimal pathology criteria; VA of ≤ 55 ETDRS letter (20/80 Snellen equivalent) or worse in the study eye

Exclusion Criteria: VA of No Light Perception; aphakic or has an anterior chamber intraocular lens in the study eye; use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified time frame prior to Visit 1

Study: Phase 1 Study of Topical Ocular PAN-90806 for Neovascular Age-related Macular Degeneration

Sponsor: PanOptica, Inc.

Purpose: To assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular AMD

Design: Interventional, Randomized, Safety, Parallel Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD

Exclusion Criteria: History of or current clinical evidence in the study eye of: aphakia, DME, any ocular inflammation or infections, pathological myopia, retinal detachment, advanced glaucoma, and significant media opacity, including cataract

Information: kcurtiss@panopticapharma.com

Study: Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD

Sponsor: Regeneron

Purpose: To investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet AMD

Design: Interventional, Safety, Single Group, Open Label

Number of Patients: 24

Inclusion Criteria: Active subfoveal choroidal neovascularization (CNV) secondary to wet AMD

Exclusion Criteria: Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor); active neovascular AMD in the fellow eye requiring treatment; scar, fibrosis, or atrophy in the study eye involving the center of the fovea

Information: clinicaltrials@regeneron.com

Study: ESBA1008 Microvolume Study

Sponsor: Alcon

Purpose: To demonstrate a treatment effect of ESBA1008 applied as microvolume injection or infusion on retinal function and morphology in subjects with exudative AMD

Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind

Number of Patients: 26

Inclusion Criteria: AMD in the study eye; VA within protocol-specified range

Exclusion Criteria: Any treatment for exudative AMD other than vitamin supplements; any current or history of macular or retinal disease; any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss

Information: alcon.medinfo@alcon.com

Study: Pilot Study of X-82 in Patients With Wet AMD

Sponsor: Xcovery Vision, LLC/Tyrogenex

Purpose: To evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet AMD

Design: Interventional, Safety/Efficacy, Single Group Assignment, Open Label

Number of Patients: 20

Inclusion Criteria: Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT; no previous treatment with anti-VEGF therapy or prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment

Exclusion Criteria: Previous treatment with photodynamic therapy (PDT) within 4 months of screening in the study eye; CNV due to causes other than AMD; geographic atrophy involving the foveal center in the study eye

Information: brittanybrown@trialrunners.com

Study: RESCUE: Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept

Sponsor: Northern California Retina Vitreous Associates/Genentech

Purpose: To determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with Bevacizumab and subsequently switched to Aflibercept

Design: Interventional, Nonrandomized, Efficacy, Parallel Assignment, Open Label

Number of Patients: 8

Inclusion Criteria: Best-corrected ETDRS VA between 20/25 to 20/320; total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion

Exclusion Criteria: History of prior vitrectomy surgery; previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery, such as dexamethasone or triamcinolone

Information: alcon.medinfo@alcon.co

WET AMD

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

Number of Patients: 45

Inclusion Criteria: VA 20/40 to 20/400; lesion size <12 DA; submacular hemorrhage <75% of total lesion and not involving foveal center; submacular fibrosis <25% of total lesion

Exclusion Criteria: Previous treatment with photodynamic therapy or thermal laser; anti- VEGF therapy within 6 weeks; intravitreal or sub-Tenon’s Kenalog within 6 months

Information: (916) 734-6074

Study: NVAMD: Neovascular Age-related Macular Degeneration

Sponsor: Oregon Health and Science University

Purpose: To assess the utility of OCT angiography in the evaluation of NVAMD

Design: Observational, Case Control, Prospective

Number of Patients: 15

Inclusion Criteria: Presence of neovascular AMD confirmed by fluorescein dye leakage on angiogram or presence of at least one of the following on OCT: subretinal fluid, intraretinal fluid, or sub-retinal pigment epithelial fluid; treatment naïve group consists of individuals who have not received any treatment for neovascular AMD in the study eye; votive treatment group consists of individuals who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit

Exclusion Criteria: Inability to maintain stable fixation for OCT imaging; significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant; a condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control); blood pressure > 180/110 (systolic above 180 OR diastolic above 110)

Study: Effects of Sildenafil on Choroidal Thickness in AMD

Sponsor: Duke University

Purpose: To compare choroidal thickness changes after a single-dose sildenafil treatment in AMD patients compared with age-matched controls

Design: Interventional, Nonrandomized, Efficacy, Single Group, Open Label

Number of Patients: 80

Inclusion Criteria: Has been diagnosed with AMD

Exclusion Criteria: History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries

Information: (919) 797-9111

Study: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging (PVOCT)

Sponsor: University of California, San Francisco

Purpose: To determine whether phase variance optical coherence tomography (PV- OCT), a software-based OCT image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography

Design: Observational, Cohort, Prospective

Number of Patients: 78

Exclusion Criteria: Any patients with ocular media opacities which prevent clear evaluation of the fundus by either FA or OCT

Information: smcclint@gmail.com

Study: Nexus: Efficacy and Safety Study of iSONEP With and Without Lucentis/Avastin to Treat Age-related Macular Edema

Sponsor: Lpath, Inc./Pfizer

Purpose: To determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis or Avastin in subjects with wet AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 160

Inclusion Criteria: Subjects who have received 3-10 IVT injections of Lucentis or Avastin within 12 months prior to screening; active subfoveal CNV secondary to AMD; presence of residual subretinal or intraretinal fluid on Cirrus or Spectralis SDOCT

Exclusion Criteria: Most recent IVT injection of Lucentis or Avastin <28 days and >65 days prior to screening; previous PDT or Macugen at any time point; focal thermal laser or grid laser within 3 months prior to Day 0; use of IVT, sub-Tenon’s or subconjunctival steroids within 3 months prior to Day 0; use of topical ophthalmic corticosteroids 2 weeks prior to Day 0

Information: info@lpath.com

Study: Safety and Efficacy of Intravitreal LFG316 in Wet Age-related Macular Edema

Sponsor: Novartis

Purpose: To assess the safety and efficacy of LFG316 in patients with AMD

Design: Randomized, Parallel Assignment, Single-blind

Number of Patients: 57

Inclusion Criteria: BCVA of 60 letters or less in the study eye; an active CNV membrane attributable to neovascular AMD

Exclusion Criteria: History of recurrent non-response to anti-VEGF therapy; retinal disease other than AMD; CNV not due to AMD

Information: (862) 778-8300

Study: Addition of 20 mg/Day Zeaxanthin to Triple Therapy Treatment Options for AMD

Sponsor: The Retina Center of St. Louis County, P.C./ZeaVision, Inc.

Purpose: To evaluate whether 20 mg per day of oral zeaxanthin as a supplement to patients with CNV and exudative AMD undergoing combination therapy with bevacizumab, dexamethasone and PDT laser photocoagulation improves outcomes

Design: Observational, Case Control, Retrospective

Number of Patients: 200

Inclusion Criteria: Subjects must have AMD with a CNV membrane either classic or occult in at least one eye; preoperative 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: Retinal disease not AMD; any presumed ocular infections, ie, bacterial, viral, parasitic, or fungal in either eye at the baseline visit; contraindication to pupillary dilation in either eye

Information: rjolk@retina-stl.com

Study: A Study of RO6867461 Administered in Single-Ascending-Dose in Patients With Wet Age-related Macular Degeneration

Sponsor: Hoffman-La Roche

Purpose: To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet AMD

Design: Interventional, Nonrandomized, Safety, Single-group Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: AMD; BCVA between 20/40 and 20/400; evidence of leakage due to CNV

Exclusion Criteria: CNV in other eye due to cause other than AMD; any intraocular inflammation

Information: global.rochegenentechtrials@roche.com

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 AMD

Design: Observational, Prospective

Number of Patients: 200

Inclusion Criteria: Group 0: No large drusen or advanced AMD; Group 1: At least one large drusen in the study eye and no large drusen or advanced AMD in the fellow eye; Group 2: Bilateral large drusen with or without RPE hypo/hyperpigmentary changes; Group 3: At least one large drusen in the study eye and advanced AMD in the fellow eye

Exclusion Criteria: Advanced AMD

Information: prpl@mail.cc.nih.gov

Study: CFH&AMD: Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration

Sponsor: Department of Veterans Affairs

Purpose: To test the hypothesis that smoking increases AMD by increasing complement activation and that this is positively correlated with known disease variations in the CFH gene

Design: Observational, Cohort, Prospective

Number of Patients: 300

Exclusion Criteria: Ocular diseases that might simulate AMD or preclude its diagnosis

Information: rohrer@musc.edu

Study: Proton Radiation Therapy for Macular Degeneration

Sponsor: University of Florida

Purpose: To determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane

Design: Interventional, Safety, Single Group, Open Label

Number of Patients: 10

Inclusion Criteria: Patients with subfoveal neovascular membranes identified on fluorescein angiography; VA (best corrected vision) 20/200 or worse in affected eye; patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab)

Exclusion Criteria: History of diabetes

Information: (877) 686-6009

Study: A Phase 3 Safety and Efficacy Study of Fovista™ (E10030) Intravitreous Administration in Combination With Lucentis Compared to Lucentis Monotherapy

Sponsor: Ophthotech Corp.

Purpose: To evaluate the safety and efficacy of intravitreal administration of Fovista™ administered in combination with Lucentis compared to Lucentis monotherapy in subjects with subfoveal choroidal neovascularization secondary to AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 622

Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component

Exclusion Criteria: Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals; any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)

Information: Karen.Lewis@ophthotech.com

DIABETIC MACULAR EDEMA

Study: Phase II Combination Steroid and Anti-VEGF for Persistent DME

Sponsor: Diabetic Retinopathy Clinical Research Network

Purpose: To assess whether the addition of steroid to an anti-VEGF treatment regimen in pseudophakic eyes has beneficial effect short-term in eyes with persistent DME and vision impairment despite previous anti-VEGF therapy, compared with continued anti-VEGF therapy alone

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 125

Inclusion Criteria: At least 6 injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 36 weeks; VA letter score in study eye ≤ 78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320); on clinical exam definite retinal thickening due to DME involving the center of the macula

Exclusion Criteria: An ocular condition is present such that, in the opinion of the investigator, VA loss would not improve from resolution of macular edema, an ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter VA during the course of the study; substantial posterior capsule opacity that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more

Information: http://drcrnet.jaeb.org/ViewPage.aspx?PageName=Home

Study: A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

Sponsor: Pfizer

Purpose: To provide an alternative mechanism to treat DME

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 200

Inclusion Criteria: Patients with diabetes mellitus (Type 1 or Type 2) showing DME; reduced VA resulting from retinal thickening

Exclusion Criteria: Severe impaired renal function; any intraocular condition or previous surgery in either eye that would likely require medical or surgical intervention during the study duration or if allowed to progress untreated for the 16 weeks of study duration, would likely contribute to a reduction in visual acuity

Information: https://trialinfoemail.pfizer.com/pages/landing.aspx

Study: Safety and Efficacy of AKB-9778 as Monotherapy or Adjunctive to Ranibizumab Compared to Ranibizumab Monotherapy in Subjects With Diabetic Macular Edema

Sponsor: Aerpio Therapeutics

Purpose: To evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with DME

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 120

Inclusion Criteria: Diagnosis of diabetes mellitus (type 1 or type 2); decrease in vision in the study eye determined to be primarily the result of DME; definite retinal thickening due to diffuse DME involving the central macula in the study eye; central subfield thickness of at least 325 µm by SD-OCT with presence of intraretinal fluid in the study eye

Exclusion Criteria: Hemoglobin A1C (HbA1C) ≥ 12.0% at screening; history of non-infectious uveitis; decrease in VA due to causes other than DME in the study eye

Information: mbrigell@aerpio.com

Study: Nepafenac Once Daily for Macular Edema

Sponsor: Alcon

Purpose: To demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 590

Inclusion Criteria: Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens; history of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy

Exclusion Criteria: Pre-existing macular edema in the study eye; history in the study eye of retinal detachment, wet AMD, or prior procedures

Information: alcon.medinfo@alcon.com

Study: ROTATE: Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

Sponsor: Southeast Retina Center, Georgia/Genentech

Purpose: To determine the safety and efficacy of intravitreally administered 0.3mg ranibizumab in subjects with persistent DME after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment)

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: Central-involved DME in study eye (OCT CSF ≥275 µm on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts); definite retinal thickening due to DME involving the center of the macula

Exclusion Criteria: Known allergy to ranibizumab; acute cardiovascular event requiring hospitalization within the past 3 months; systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study; macular edema is considered to be due to a cause other than DME

Information: dmarcus@southeastretina.com

Study: OPERA: Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl

Sponsor: Cleveland Clinic/Allergan

Purpose: To examine the use of the dexamethasone implant (Ozurdex) in patients with DME associated with an epiretinal or preretinal membrane requiring surgical intervention

Design: Interventional, Single Group Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: Patients who are undergoing pars plana vitrectomy for: epiretinal membrane/vitreomacular traction or DME; patients with macular edema as measured by OCT (at least 250 µm central subfoveal thickness)

Exclusion Criteria: History of active inflammatory eye disease (uveitis) (within 3 months); history of ocular malignancy and/or ocular/orbital irradiation; history of recent retinal vein occlusion (within 6 months)

Information: srivass2@ccf.org

Study: Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery

Sponsor: Lahey Clinic

Purpose: To assess the safety and efficacy of Ozurdex after vitrectomy

Design: Randomized, Safety/Efficacy, Single- group Assignment, Double-blind

Number of Patients: 15

Inclusion Criteria: Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is >300 µm with intraretinal cystic edema; BCVA between 20/40 to 20/400

Exclusion Criteria: Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition; patient with history of steroid response with IOP >35 mm Hg or requirement to be on >2 glaucoma medications following previous steroid injection

Information: avon.p.stewart@lahey.org

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Study: Ranibizumab and Bevacizumab for Diabetic Macular Edema

Sponsor: National Eye Institute

Purpose: To compare ranibizumab and bevacizumab injections for DME

Design: Interventional, Randomized, Safety/Efficacy, Crossover Assignment, Double-blind

Number of Patients: 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

Exclusion Criteria: Eye has an ocular condition present such that, VA would not improve from resolution of macular edema

Information: wileyhe@mail.nih.gov

Study: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Sponsor: Retina Macula Institute/Allergan

Purpose: To test the efficacy of a 0.7-mg intravitreal dexamethasone implant on macular leakage and VA for patients with recalcitrant DME

Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind

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

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 vs a duel therapy of 0.5 mg ranibizumab combined with ultrawide, 200° field angiography guided PRP in patients with CSME-CI secondary to diabetes mellitus

Design: Interventional, Randomized, Safety/ Efficacy, Single Group, Open Label

Number of Patients: 40

Inclusion Criteria: BCVA of 20/32 to 20/200; high-definition OCT central thickness measurement of ≥ 300 μm; decrease in VA determined to be the result of DME

Exclusion Criteria: Prior ocular treatment; history of vitrectomy surgery in the study eye; any panretinal photocoagulation in the study eye; prior treatment with intraocular or subconjunctival steroids in the study eye

Information: dmbmd@houstonretina.com

Study: Protocol V: Treatment for CI-DME in Eyes With Very Good VA Study

Sponsor: Diabetic Retinopathy Clinical Research Network/Genentech

Purpose: To compare the percentage of eyes that have lost at least 5 letters of VA at 2 years compared with baseline mean VA in eyes with central-involved DME and good VA

Design: Randomized, Interventional, Safety/Efficacy, Parallel Assignment, Single-blind Treatment

Number of Patients: 702

Inclusion Criteria: Best corrected E-ETDRS VA letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days; on clinical exam, definite retinal thickening due to DME

Exclusion Criteria: Macular edema is considered to be due to a cause other than DME

Information: drcrnet@jaeb.org

DIABETIC MACULAR EDEMA

Study: A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug) in the Treatment of Diabetic Macular Edema

Sponsor: Ampio Pharmaceuticals

Purpose: To evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of DME vs placebo

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 450

Inclusion Criteria: Stable diabetic and metabolic control (no major changes in diabetic or lipid reducing medications for 3 months prior to start of this study as determined by the Investigator)

Exclusion Criteria: Known allergy to any danazol or any other non-medicinal component of the danazol test drug

Information: hloose@ampiopharma.com

Study: TREX-DME: A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema

Sponsor: Palmetto Retina Center, LLC

Purpose: To determine if a “Treat and Extend” regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes

Design: Randomized, Safety/Efficacy, Factorial Assignment, Open Label

Number of Patients: 150

Inclusion Criteria: The presence of center-involving diabetic macular edema on clinical exam and SDOCT; BCVA in the study eye, using ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive; clear ocular media and adequate pupillary dilation to permit good quality fundus imaging

Exclusion Criteria: History of active proliferative diabetic retinopathy in the study eye on clinical exam; history of vitrectomy surgery, submacular surgery, or other intraocular surgical intervention for diabetic macular edema in the study eye; any previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-VEGF drugs including ranibizumab, or device implantation) in the study eye within 90 days of the screening visit

Information: ccahill@palmettoretina.com

Study: DMEO: Diabetic Macular Edema Treated With Ozurdex

Sponsor: Johns Hopkins University

Purpose: To measure the pro-permeability factors VEGF, SDF-1, and angiopoietin-2 in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents

Design: Efficacy, Single Group, Open Label

Number of Patients: 20

Inclusion Criteria: Diagnosis of diabetic macular edema; intraretinal or subretinal fluid in the macula determined by Spectralis OCT; best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive

Exclusion Criteria: Intraocular surgery in the study eye within 3 months of study entry; use of intraocular or periocular injection of steroids in the study eye (eg, triamcinolone) within 4 months of study entry; previous use of an anti-VEGF drug within 1 month of study entry

Information: ghafiz1@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

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) or after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab)

Design: Randomized, Interventional, Efficacy, Parallel Assignment, Single-blind Treatment

Number of Patients: 30

Inclusion Criteria: 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 >21 mm Hg on more than one topical medicatio: 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: (732) 797-3984

Study: Minocycline to Treat RVO

Sponsor: National Eye Institute

Purpose: To test the safety and effectiveness of minocycline as a treatment for branch retinal vein occlusion

Design: Randomized, Interventional, Efficacy, Parallel Assignment, Double-blind Treatment

Number of Patients: 20

Inclusion Criteria: The study eye has a best-corrected ETDRS visual acuity score between 78 and 34 letters

Exclusion Criteria: The macular edema is considered to be related to cataract extraction, or clinical examination and/or OCT suggest that vitreoretinal interface disease (eg, a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or clinical examination, medical history and/or fluorescein angiography suggest that diabetic retinopathy is the primary cause of the edema; the study eye has a history of a recurrent RVO

Information: meg.gordon@nih.gov

RETINAL VEIN OCCLUSION

Study: Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

Sponsor: Weill Medical College of Cornell University

Purpose: To determine whether thrombolysis can improve visual acuity and prevent the long-term complications of CRVO

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: Contraindication 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); or any other condition which in the opinion of the investigators would preclude the use of thrombolytic agents

Information: kas2004@med.cornell.edu

Study: Study of Intravitreal Aflibercept Injection for Persistent CRVO-associated Macular Edema Despite Prior Anti-VEGF Therapy

Sponsor: Tennessee Retina/Regeneron

Purpose: To determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept

Design: Interventional, Single Group Assignment, Open Label, Treatment

Number of Patients: 20

Inclusion Criteria: Presence of persistent macular edema (defined as any of the following): central foveal thickness (CFT) of > 300 microns by spectral-domain OCT; presence of any intraretinal or subretinal fluid; receipt of intravitreal anti-VEGF injections more frequently than once per month

Exclusion Criteria: Prior vitrectomy in the study eye; concurrent retinal vascular disease in the study eye that could compromise visual acuity or contribute to macular edema; any concurrent intraocular condition in the study eye (eg, diabetic retinopathy, advanced glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 6-month study period to prevent or treat visual loss; or, if allowed to progress untreated, contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity

Information: kas2004@med.cornell.edu

Study: WAVE: Targeted Laser With Lucentis 0.5mg Verses L Lucentis 0.5mg Monotherapy for Ischemic Central Vein, Hemi Retinal Vein Occlusion and Branch Retinal Vein Occlusion

Sponsor: Charles C Wykoff, PhD, MD/Genentech

Purpose: To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, compared to standard of care

Design: Randomized, Safety/Efficacy, Single Group, Open Label

Number of Patients: 30

Inclusion Criteria: Subjects with ischemic central retinal vein occlusion with at least 2 consecutive monthly intravitreal injections of anti-VEGF medications with presence of persistent edema in the past 4 months; visual acuity between 20/25 and 20/800, ETDRS visual acuity

Exclusion Criteria: IOP over 30 mm Hg; any previous retinal laser photocoagulation to the study eye; previous intravitreal injection in the study eye of any corticosteroid treatment; inability to assess iris or angle neovascularization (corneal opacity precluding gonioscopy)

Information: ccwmd@houstonretina.com

Study: Minocycline to Treat Retinal Vein Occlusion

Sponsor: National Eye Institute

Purpose: To test the safety and effectiveness of minocycline as a treatment for RVO

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 40

Inclusion Criteria: The study eye shows evidence of definite retinal thickening due to RVO 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. RVO is defined as an eye that had retinal hemorrhage or other biomicroscopic evidence of RVO (eg, 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. Hemiretinal vein occlusion (HRVO) is an RVO that involves two altitudinal quadrants. In this study, eyes with a HRVO will be considered a RVO and are given the same treatment as RVO eyes

Exclusion Criteria: The macular edema is considered to be related to cataract extraction, or clinical examination and/or OCT suggest that vitreoretinal interface disease (eg, a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, orclinical examination, medical history and/or fluorescein angiography suggest that diabetic retinopathy is the primary cause of the edema

Information: meg.gordon@nih.gov

Study: NEWTON: Aflibercept Injection for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions

Sponsor: Northern California Retina Vitreous Associates/Regeneron

Purpose: To determine the effect of Intravitreal Aflibercept Injection (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF agents

Design: Efficacy, Single Group, Open Label

Number of Patients: 30

Inclusion Criteria: Patients must have received treatment for at least 6 months before baseline, with 3 initial loading doses, and evidence of recurrence of edema when extended beyond 4 weeks; protocol refracted ETDRS BCVA of 20/25 to 20/320 (73-24 letters)

Exclusion Criteria: Prior panretinal or macular laser photocoagulation; previous use of intraocular corticosteroids or use of periocular corticosteroids within the 3 months prior to day 1; prior treatment with systemic anti-VEGF agents; presence of iris neovascularization

Information: laguda@ncrva.com

Study: ORION: Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion

Sponsor: Valley Retina Institute

Purpose: To determine the safety and effectiveness of treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex and 0.5 mg Lucentis, given as separate injections into the eye

Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-blind

Number of Patients: 45

Inclusion Criteria: Adults greater than or equal to 18 years of age with foveal center involved macular edema secondary to CRVO diagnosed within 12 months before the screening visit (CRVO is defined as an eye with retinal hemorrhage or other biomicroscopic evidence of RVO [eg, telangiectatic capillary bed] and a dilated [or previously dilated] venous system in at least 3 quadrants of the retina drained by the affected vein)

Exclusion Criteria: History of vitreoretinal surgery in the study eye or anticipated within 12 months of Day 1; current bilateral manifestation of CRVO; decrease in VA due to causes other than CRVO in the study eye; prior episode of RVO in study eye

Information: dgarcia@vritx.com

Study: Effect of Ozurdex 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion

Sponsor: Texas Retina

Purpose: To determine if the addition of Ozurdex to bevacizumab (Avastin) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion

Design: Safety/Efficacy, Parallel Assignment, Single-blind

Number of Patients: 68

Exclusion Criteria: Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; use of systemic steroids within 1 month prior to baseline visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed); sitting systolic blood pressure equal to or greater than 160 mm Hg or diastolic blood pressure equal to or greater than 100 mm Hg at the baseline visit (Visit 1); use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study

Information: (732) 797-3984

Study: Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

Sponsor: University of California, Davis

Purpose: To determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions

Design: Safety/Efficacy, Single Group, Open Label

Number of Patients: 15

Inclusion Criteria: Visual acuity 20/200 to CF; curation of vision loss > 3 months; vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion, or diabetic retinopathy; the study eye has the worse visual acuity

Exclusion Criteria: allergy to fluorescein dy; other concurrent retinal or optic nerve disease affecting vision

Information: marisa.salvador@ucdmc.ucdavis.edu

NO LONGER ENROLLING

Study: ATLAS: Repeated Eye Injections of Aflibercept for Treatment of Wet AMD

Sponsor: Brian Burke, MPH/Regeneron

Information: research@midatlanticretina.com

Study: GEM: Phase I Dose Escalation Safety Study of RetinoStat in Advanced AMD

Sponsor: Oxford BioMedica

Information: pcampo@jhmi.edu

Study: Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With GA Secondary to AMD

Sponsor: GlaxoSmithKline

Information: GSKClinicalSupportHD@gsk.com

Study: Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration

Sponsor: Arshad Khanani/Genentech

Information: ddorman@sierraeyeassociates.com

Study: Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) AMD

Sponsor: Ohr Pharmaceuticals, Inc.

Information: itaraporewala@ohrpharmaceutical.com

Study: Dextromethorphan for Diabetic Macular Edema

Sponsor: National Eye Institute

Information: meg.gordon@nih.gov

STUDIES WITH RESULTS

Study: SIRGA2: Sirolimus for Advanced Age-Related Macular Degeneration

Sponsor: National Eye Institute

Information: http://clinicaltrials.gov/ct2/show/results/NCT01445548

Study: Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival

Sponsor: Retina Vitreous Associates of Florida

Information: http://clinicaltrials.gov/ct2/show/results/NCT01640171