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
DRY AMD
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
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 neovascularization 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: 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 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
WET AMD
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: 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
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: A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Sponsor: Allergan
Purpose: To study the safety and efficacy of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 25
Inclusion Criteria: Diagnosis of wet age-related macular degeneration in at least 1 eye; best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion Criteria: Hypersensitivity, allergy, or anaphylactic reaction to iodine; cataract or refractive surgery within the last 3 months; history of vitrectomy
Information: clinicaltrials@allergan.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
DIABETIC MACULAR EDEMA
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
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: 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: 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
Study: A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
Sponsor: Allergan
Purpose: To study the safety and efficacy of abicipar pegol in patients with diabetic macular edema
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 140
Inclusion Criteria: Decreased vision due to diabetic macular edema in at least 1 eye; best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion Criteria: Stroke or heart attack within the past 3 months; history of vitrectomy, macular surgery, or glaucoma surgery in the study eye; cataract or refractive surgery in the study eye within the last 3 months; laser photocoagulation of the study eye within the last 3 months
Information: clinicaltrials@allergan.com
Study: A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
Sponsor: Raj K. Maturi, MD/Allergan
Purpose: To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema
Design: Randomized, Efficacy, Parallel Assignment, Single-blind
Number of Patients: 60
Inclusion Criteria: BCVA score of >24 and <78 letters; history of at least 3 anti-VEGF intravitreal injections over the past 5 months; presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT
Exclusion Criteria: Anti-VEGF intravitreal treatment in the last 4 weeks; intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months; PRP or focal laser in the last 4 months; active iris neovascularization
Information: rmaturi@gmail.com
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
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 medication: combination drugs are considered more than one medication; history of steroid-related glaucoma (steroid response); previous intraocular injection of steroid medication within 90 days; Avastin (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
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 Versus 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 investigators’ 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, or clinical 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
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; duration 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 dye; other concurrent retinal or optic nerve disease affecting vision
Information: marisa.salvador@ucdmc.ucdavis.edu
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
Study: Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies
Sponsor: Wake Forest School of Medicine
Information: http://clinicaltrials.gov/ct2/show/results/NCT00779142
Study: A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Sponsor: Glenn Jaffe/Bausch + Lomb, Inc.
Information: http://clinicaltrials.gov/ct2/show/results/NCT00952614