Article

CLINICAL TRIAL UPDATE

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: 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

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: SPECTRI: A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Sponsor: Hoffmann-La Roche

Purpose: To conduct a study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration

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

Number of Patients: 936

Inclusion Criteria: Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD; previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy; previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)

Information: global.rochegenentechtrials@roche.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: CHROMA: A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Sponsor: Hoffmann/La Roche

Purpose: To evaluate the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration

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

Number of Patients: 936

Inclusion Criteria: Participants aged >/= 50 years; well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD; previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy; previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes: GA in either eye due to causes other than AMD; previous treatment with eculizumab, lampalizumab and/or fenretinide

Information: global.rochegenentechtrials@roche.com

Study: TOGA: Clinical Study to Evaluate Treatment With ORACEA for Geographic Atrophy

Sponsor: Paul Yates, MD, PhD/MEDARVA

Purpose: To evaluate the efficacy and safety of ORACEA in the treatment of geographic atrophy due to dry age-related macular degeneration

Design: Randomized, Parallel Assignment, Double-blind

Number of Patients: 286

Inclusion Criteria: Best-corrected visual acuity of 20/20 - 20/400 in the study eye; best-corrected visual acuity of hand motion or better in the non-study eye; clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye); geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas

Exclusion Criteria: History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye; history of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to Day 0 or expected to require treatment for the duration of the study; prior treatment for non-exudative age-related macular degeneration

Information: klh7v@virginia.edu

Study: A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

Sponsor: Genentech

Purpose: To investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in patients with geographic atrophy (GA) secondary to age-related macular degeneration

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

Number of Patients: 100

Inclusion Criteria: Patients aged 60-89 years with well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization

Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD; previous subfoveal focal laser photocoagulation; laser photocoagulation in the study eye; previous intravitreal drug administration; GA in either eye due to causes other than AMD

Information: global.rochegenentechtrials@roche.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: 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: 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.com

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 subretinal pigment epithelial fluid; treatment naïve group consists of individuals who have not received any treatment for neovascular AMD in the study eye; previous treatment group consists of individuals who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior to 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: 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: 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

WET AMD

Study: Phase 2A Open Label Safety Study of Fovista (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

Sponsor: Ophthotech

Purpose: To evaluate the safety of intravitreal Fovista (anti-PDGF BB) administered in combination with anti-VEGF therapy

Design: Single Group, Open Label

Number of Patients: 100

Inclusion Criteria: All fluorescein angiographic subtypes with presence of active choroidal neovascularization

Exclusion Criteria: Any intraocular surgery or thermal laser within three months of trial entry. Any prior thermal laser in the macular region, regardless of indication; subjects with subfoveal scar or subfoveal atrophy; any ocular or periocular infection in the past 12 weeks

Information: jeff.nau@ophthotech.com

Study: PREVENT: Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

Sponsor: Southern California Desert Retinal Consultants

Purpose: To determine whether quarterly injections of ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration

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

Number of Patients: 100

Inclusion Criteria: Nonexudative age-related macular degeneration (AMD) in one eye (study eye); history of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment

Exclusion Criteria: Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.

Information: mlalezary@desertretina.com

Study: EMERGE: Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Sponsor: Iconic Therapeutics

Purpose: To evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration

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

Number of Patients: 90

Inclusion Criteria: Active primary CNV secondary to AMD in the study eye; BCVA of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye

Exclusion Criteria: Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye; any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins; planned or ongoing anti-VEGF treatment in the non-study eye Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months; vitrectomy in the study eye; hereditary or chronic hemorrhagic or coagulopathy conditions (ie, hemophilia)

Information: clinicaltrials@iconictherapeutics.com

Study: DREAM: Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

Sponsor: Bayer

Purpose: To investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) age-related macular degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study

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

Number of Patients: 350

Inclusion Criteria: Active primary subfoveal CNV (choroidal neovascularization) lesions secondary to AMD age-related macular degeneration), including juxtafoveal lesions that affect the fovea as evidenced by FA (fluorescein angiography) in the study eye and reviewed by the central reading center; the area of CNV must occupy at least 50% of total lesion in the study eye, as determined by FA review at the central reading center; evidence of intraretinal and/or subretinal fluid on OCT (optical coherence tomography)

Exclusion Criteria: Concurrent disease in the study eye, other than AMD (eg, corneal diseases and dystrophies, conjunctival diseases, eye lid abnormalities, or any other diseases of the cornea and macula, or optic nerve abnormality) that could compromise visual acuity, likely require medical or surgical intervention during the study period, would limit the potential to gain or lose vision during study treatment, or could otherwise confound interpretation of the results; total lesion size (including neovascularization, scar, blood) >12 disc areas (30.5 mm2) as assessed by FA; only one functional eye, even if that eye is otherwise eligible for the study

Information: clinical-trials-contact@bayerhealthcare.com

Study: Treatment-Resistant Neovascular Age-Related Macular Degeneration

Sponsor: Washington University School of Medicine

Purpose: To determine if treatment of age related macular degeneration (AMD) with a new medication, rituximab, is effective

Design: Nonrandomized, Efficacy, Single Group, Open Label

Number of Patients: 5

Inclusion Criteria: Patients who have a central visual acuity, 20/200; patients who have been deemed “treatment-resistant” at the discretion of the treating physician

Exclusion Criteria: Patients with treatment failure for neovascular AMD; patients who have tried multiple anti-VEGF medication without anatomical or objective improvement

Information: pistoriuss@vision.wustl.edu

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

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

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

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

DIABETIC MACULAR EDEMA

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: 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

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

Information: drcrnet@jaeb.org

Study: A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME

Sponsor: KalVista Pharmaceuticals, Ltd./JDRF

Purpose: To investigate the safety, tolerability of the novel plasma kallikrein inhibitor KVD001 in subjects with diabetic macular edema

Design: Nonrandomized, Safety, Single Group, Open Label

Number of Patients: 17

Inclusion Criteria: Best-corrected visual acuity, using Early Treatment Diabetic Retinopathy Study (ETDRS) electronic visual acuity (EVA) testing, of between 20/40 and 20/400 (Snellen equivalent) in the study eye; fellow eye acuity 20/80 or better measured as above with no expectation of requirement for anti-VEGF treatment in fellow eye within 2 months of study drug administration

Exclusion Criteria: Media clarity or pupillary dilation inadequate to obtain reasonable quality OCT and/or fundus image; significant coexisting disease

Information: www.kalvista.com

Study: REACT: Safety and Efficacy of Ranibizumab for DME

Sponsor: Cleveland Clinic/Genentech

Purpose: To assess the ocular and systemic adverse events of ranibizumab (Lucentis) for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin)

Design: Safety/Efficacy, Single Group, Single-blind, Treatment

Number of Patients: 30

Inclusion Criteria: ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye; willing, committed, and able to return for all clinic visits and complete all study related procedures; at least 6 previous bevacizumab injections for diabetic macular edema in the last 12 months

Exclusion Criteria: Intravitreal steroid or periocular steroid treatment within 3 months of study entry; focal/grid laser photocoagulation treatment within 3 months of study entry; panretinal photocoagulation treatment within 3 months of study entry

Information: DASTOLK@ccf.org

Study: PROMISE: Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery

Sponsor: Cleveland Clinic/Regeneron

Purpose: To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in patients with diabetic retinopathy in the prevention of macular edema following cataract surgery

Design: Randomized, Safety/Efficacy, Single Group, Single-blind, Prevention

Number of Patients: 30

Inclusion Criteria: Non-proliferative diabetic retinopathy (mild, moderate, or severe) or inactive proliferative disease in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale

Exclusion Criteria: Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator; current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment

Information: DASTOLK@ccf.org

Study: A Study of MTP-131 Topical Ophthalmic Solution in Subjects With DME and Non-Exudative Intermediate AMD

Sponsor: Stealth Peptides, Inc.

Purpose: To determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema

Design: Nonrandomized, Safety/Efficacy, Open Label

Number of Patients: 21

Inclusion Criteria: Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits; BCVA (ETDRS) no better than 20/25

Exclusion Criteria: Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination

Information: (617) 600-6888

Study: A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema

Sponsor: RiverVision Development Corp.

Purpose: To evaluate the safety of teprotumumab in patients with diabetic macular edema

Design: Safety, Single Group, Open Label, Treatment

Number of Patients: 10

Inclusion Criteria: Clinically significant DME of less than 12 months duration; non-proliferative diabetic retinopathy of moderate severity; best corrected electronic ETDRS letter score < 78 and > 24

Exclusion Criteria: Systemic anti-vascular endothelial growth factor (VEGF) treatment within four months prior to enrollment; history of pan retinal photocoagulation within four months prior to enrollment; history of ocular surgery within four months prior to enrollment

Information: kcgabriel2@verizon.net

Study: A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema

Sponsor: Allegro Ophthalmics

Purpose: To evaluate the safety and efficacy of Luminate compared to Avastin and focal laser in the treatment of DME

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

Number of Patients: 150

Inclusion Criteria: Best-corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME; treatment naïve, ie, no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment; in the investigator’s opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA; IOP is under control (ie, IOP ≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops

Exclusion Criteria: Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma; uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen; screening HgA1c blood test > 10.0; focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment

Information: (949) 940-8130

Study: VIDI: A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema

Sponsor: Astellas Pharma Europe BV

Purpose: To evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) for ASP8232 monotherapy at month 3

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

Number of Patients: 84

Inclusion Criteria: Subject has definite retinal thickening due to diffuse diabetic macular edema (DME) involving the central macula based on evaluating investigator’s clinical evaluation and demonstrated by spectral domain-optical coherence tomography (SD-OCT); subject has central subfield thickness (CST) of at least 375 μm by SD-OCT with presence of intraretinal and/or subretinal fluid at screening visit and at the randomization visit

Exclusion Criteria: Subject’s study eye has macular edema considered to be due to a cause other than DME; subject’s study eye has a decrease in BCVA due to causes other than DME that is likely to be decreasing BCVA by 3 lines or more; subject’s study eye has significant macular ischemia as shown on angiography; subject’s study eye has any other ocular disease that may cause substantial reduction in BCVA

Information: Astellas.registration@astellas.com

Study: Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by CRVO

Sponsor: Long Island Vitreoretinal Consultants

Purpose: To compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO) 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 medication: combination drugs are considered more than one medication

Information: (732) 797-3984

Study: Intra-arterial Thrombolysis for Severe Recent CRVO

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

Information: kas2004@med.cornell.edu

RETINAL VEIN OCCLUSION

Study: WAVE: Widefield Angiography Guided Targeted-retinal Photocoagulation Combined With Anti VEgf Intravitreal Injections for the Treatment of Ischemic CRVO, Hemi-RVO, and BRVO

Sponsor: Charles C Wykoff, PhD, MD/Genentech

Purpose: To see if Lucentis 0.5mg combined with targeted PRP will decrease the total no. of injections per year for ischemic CRVO

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

Number of Patients: 30

Inclusion Criteria: Ischemic CRVO with at least 2 consecutive monthly anti-VEGF injections

Exclusion Criteria: IOP >30 mm Hg; previous retinal laser photocoagulation or intravitreal injection of any corticosteroid

Information: ccwmd@houstonretina.com

Study: Minocycline to Treat RVO

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: Evidence of definite retinal thickening due to RVO involving the center of the macula

Exclusion Criteria: Macular edema related to cataract extraction, or clinical examination and/or OCT suggest that vitreoretinal interface disease is the primary cause of the macular edema, or clinical examination

Information: meg.gordon@nih.gov

Study: ORION: Ozurdex vs Ranibizumab vs Combination for CRVO

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

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

Number of Patients: 45

Inclusion Criteria: Foveal center involved macular edema secondary to CRVO diagnosed within 12 months

Exclusion Criteria: History of vitreoretinal surgery in the study eye or anticipated within 12 months of Day 1; bilateral CRVO

Information: dgarcia@vritx.com

Study: Effect of Ozurdex 0.7 mg on Improvement of Efficacy of Bevacizumab for CRVO

Sponsor: Texas Retina

Purpose: To determine if the addition of Ozurdex to Avastin eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic CRVO

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 unsuitable for the study or confound the study results

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: VA 20/200 to CF; duration of vision loss > 3 months; vision loss from AMD, retinitis pigmentosa, RVO, or DR

Exclusion Criteria: Allergy to fluorescein dye; other retinal or optic nerve disease

Information: marisa.salvador@ucdmc.ucdavis.edu

Study: SCORE2: Study of Comparative Treatments for RVO 2

Sponsor: The EMMES Corp./NEI/Hershey Medical Center/Univ. Wisconsin

Purpose: To determine if bevacizumab is noninferior to aflibercept for the treatment of macular edema associated with CRVO, with the primary outcome of VA measured at Month 6

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

Number of Patients: 360

Inclusion Criteria: Must have center-involved macular edema secondary to CRVO

Exclusion Criteria: Examination evidence of vitreoretinal interface disease

Information: pvanveldhuisen@emmes.com

Study: Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to RVO

Sponsor: Brian Burke, MPH

Purpose: To compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to BRVO or CRVO

Design: Randomized, Efficacy, Parallel Assignment, Open Label

Number of Patients: 30

Inclusion Criteria: RVO diagnosed within two weeks of symptom onset; BCVA on initial presentation between 20/40 and 20/320

Exclusion Criteria: Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid laser; patients with DR or AMD

Information: research@midatlanticretina.com

Study: TANZANITE: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

Sponsor: Clearside Biomedical, Inc.

Purpose: To evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with RVO

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

Number of Patients: 40

Inclusion Criteria: Diagnosis of macular edema following RVO; history of ME ≤ 12 months; 20-70 letters inclusive BCVA

Exclusion Criteria: Has had an IVT injection of anti-VEGF for RVO in the study eye; corticosteroid injection in the past 3 months

Information: michelle.widmann@clearsidebio.com