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

Sponsor: GlaxoSmithKline

Purpose: To determine the safety and efficacy of GSK933776 in the treatment of GA secondary to AMD

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

Number of Patients: 162

Inclusion Criteria: Evidence of AMD confirmed by the presence of at least 1 drusen ≥125 µm; well-demarcated GA due to AMD

Exclusion Criteria: Additional eye disease that could compromise assessment of BCVA or imaging of the posterior pole; history of CNV; previous treatment for AMD, with the exception of dietary supplements

Information: GSKClinicalSupportHD@gsk.com

DRY AMD

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: 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

WET AMD

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

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

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

Exclusion Criteria: Significant ocular abnormalities that prevent retinal assessment; treatment with steroids within three months of screening; treatment with anti-VEGF therapy within one month of screening

Information: pcampo@jhmi.edu

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)

WET AMD

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

Sponsor: Brian Burke, MPH/Regeneron

Purpose: To evaluate the visual outcome and number of injections required during an OCT-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular AMD

Design: Interventional, Nonrandomized, Parallel Assignment, Open Label

Number of Patients: 40

Inclusion Criteria: Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible; patients cannot have concurrent progressive retinal disease

Exclusion Criteria: Prior treatment for NVAMD in the study eye; prior experimental treatment of NVAMD; prior treatment with systemic anti-VEGF agents; prior treatment with verteporfin

Information: research@midatlanticretina.com

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

Sponsor: Arshad Khanani/Genentech

Purpose: To compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept

Design: International, Nonrandomized, Parallel Assignment, Single-blind

Number of Patients: 100

Inclusion Criteria: New onset Neovascular AMD; previously treated Neovascular AMD with Lucentis or Eylea intravitreal injections; VA of 20/400 or better

Exclusion Criteria: History of Endophthalmitis in either eye; uncontrolled or symptomatic Dry Eye Syndrome; history of Anterior or Posterior Uveitis; history of Post injection pain or inflammation with prior treatments; recent thromboembolic event (<3 months)

Information: ddorman@sierraeyeassociates.com

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

Sponsor: Ohr Pharmaceuticals, Inc.

Purpose: To evaluate the safety and efficacy of topical squalamine lactate eye drops in treating patients with neovascular AMD

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

Number of Patients: 120

Inclusion Criteria: A diagnosis of CNV secondary to AMD with total lesion area ≤ 12 disc areas with CNV affecting at least 50% of the total lesion area confirmed by FA

Exclusion Criteria: Neovascularization secondary to any condition other than AMD in the study eye; blood occupying greater than 50% of the AMD lesion

Information: itaraporewala@ohrpharmaceutical.com

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 (PVOCT), 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 Uncontrolled systemic disease.

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

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

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

DIABETIC MACULAR EDEMA

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 VA

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: Dextromethorphan for Diabetic Macular Edema

Sponsor: National Eye Institute

Purpose: To see if dextromethorphan can help treat DME

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

Number of Patients: 8

Inclusion Criteria: BCVA ETDRS score of 34 letters or better (ie, 20/200 or better) Definite retinal thickening due to DME based on clinical examination that is not refractory to further therapy

Exclusion Criteria: An ocular condition is present such that, in the opinion of the investigator, VA would not improve from resolution of macular edema (eg, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition); an ocular condition is present

Information: meg.gordon@nih.gov

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

DIABETIC MACULAR EDEMA

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

Study: CDDR: Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

Sponsor: IDx LLC

Purpose: To determine whether computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Board-certified ophthalmologist

Design: Observational, Case-only, Prospective

Number of Patients: 600

Inclusion Criteria: No history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed); other than cataract surgery

Exclusion Criteria: A history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc; previous intraocular surgery other than cataract; previous laser to the retina

Information: (713) 559-5200

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

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