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: 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: 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

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: RADIANT: Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

Sponsor: StemCells, Inc.

Purpose: To evaluate the safety and efficacy of sub-retinal transplantation of stem cells in subjects with bilateral GA AMD

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

Number of Patients: 63

Inclusion Criteria: GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence; BCVA of 20/320 or better in each eye at screening assessment

Exclusion Criteria: Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center; retinal or macular disease of any other cause in either eye; diagnosis of glaucoma in either eye; uncontrolled intraocular pressure in either eye

Information: kglocke@retinafoundation.org

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

WET AMD

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: 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

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: 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: 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: 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 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

Information: clinicaltrials@iconictherapeutics.com

Study: Efficacy and Safety of RTH258 Versus Aflibercept

Sponsor: Alcon

Purpose: To compare RTH258 ophthalmic solution for intravitreal (IVT) injection at two dosage levels to aflibercept solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye

Design: Randomized, Parallel Assignment, Double-blind

Number of Patients: 1,600

Inclusion Criteria: Active CNV lesions secondary to AMD in the study eye; intra and/or subretinal fluid affecting the central subfield of the study eye; BCVA between 78 and 23 letters, inclusive, in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) testing

Exclusion Criteria: Any active intraocular or periocular infection or active intraocular inflammation in either eye; fibrosis or geographic atrophy; any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time; any history or evidence of a concurrent intraocular condition in the study eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the course of the study to prevent or treat visual loss

Information: alcon.medinfo@alcon.com

Study: LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Age-Related Macular Degeneration

Sponsor: Alcon

Purpose: To evaluate the efficacy of 12 successive weeks of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis) for recurrence of active choroidal neovascularization (CNV)

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

Number of Patients: 60

Inclusion Criteria: Wet AMD; active CNV lesion due to AMD in the study eye; BCVA between 75-35 letters, inclusive in the study eye; BCVA 20 letters in the fellow eye

Exclusion Criteria: Any active ocular or periocular infection or intraocular inflammation; history of visual impairing central keratitis or endophthalmitis in the study eye; received >25 IVT injections of anti-VEGF therapy in the study eye; initial diagnosis of wet AMD in the study eye >3 years prior to screening visit; current or history of macular or retinal disease other than wet AMD in the study eye

Information: alcon.medinfo@alcon.com

Study: Sirolimus vs AntiVEGF for Wet AMD

Sponsor: Raj K. Maturi, MD, PC

Purpose: To determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet age-related macular degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous anti-VEGF treatment

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

Number of Patients: 30

Inclusion Criteria: Best corrected visual acuity of 5-65, inclusive, in study eye; presence of choroid neovascularization secondary to AMD; persistent edema despite at least 3 previous intravitreal anti-VEGF injections in 5 months

Exclusion Criteria: Greater than 100 micron decrease in central subfield thickness on OCT since last standard of care visit; history of major ophthalmic surgery in the study eye in the past 3 months; history of significant ocular disease or condition other than exudative AMD

Information: rmaturi@gmail.com

WET AMD

Study: Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular (“Wet”) Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)

Sponsor: Regeneron

Purpose: To investigatethe safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME)

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

Inclusion Criteria: Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study eye, as determined by the investigator

Exclusion Criteria: Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye; evidence of diabetic retinopathy (DR) or DME in either eye

Information: clinicaltrials@regeneron.com

Study: VAPOR1: A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration

Sponsor: Santen Inc.

Purpose: To evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration

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

Number of Patients: 30

Inclusion Criteria: Diagnosis of active CNV secondary to wet AMD, with some subfoveal component in the study eye; no evidence of subfoveal fibrosis or subfoveal RPE atrophy in the study eye; at least one lesion in the study eye that meets minimal pathology criteria; best corrected visual acuity of 70 to 25 ETDRS letters in the study eye

Exclusion Criteria: Aphakic or has an anterior chamber intraocular lens in the study eye; received prior treatment with anti-VEGF, intravitreal corticosteroids or photodynamic therapy in the study eye; uncontrolled glaucoma despite anti-glaucoma therapy in the study eye; evidence of any ocular disease other than AMD in the study eye that may confound the outcome of the study; history of vitrectomy in the study eye

Information: clinicaltrials@santeninc.com

Study: ASAP II: Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal APL-2 for Patients With Wet AMD

Sponsor: Apellis Pharmaceuticals

Purpose: To provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of APL-2 in order to support further development into larger Phase II studies for treatment of patients with AMD

Design: Nonrandomized, Safety, Single Group, Open Label

Number of Patients: 9

Inclusion Criteria: The presence of an active choroidal neovascular lesion secondary to AMD; on treatment with anti-VEGF therapy (Lucentis®, Eylea® or Avastin®); must have received at least 3 anti-VEGF treatments over the 26-week period prior to screening (Screening Visit); evidence that the macular fluid has responded to anti-VEGF in the past based on OCT in the opinion of the PI

Exclusion Criteria: Choroidal neovascularization associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision due to retinal disease not attributable to choroidal neovascularization, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy

Information: federico@apellis.com

Study: An 18 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

Sponsor: Ophthotech Corporation

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

Design: Randomized, Safety, Parallel Assignment, Open Label

Number of Patients: 60

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

Exclusion Criteria: Any intraocular surgery or thermal laser within three (3) 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 twelve (12) weeks; history of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Information: jeff.nau@ophthotech.com

Study: X-82 to Treat Age-related Macular Degeneration

Sponsor: Tyrogenex

Purpose: To evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD

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

Number of Patients: 132

Inclusion Criteria: Participants must have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 1 year prior to joining the study and has required at least three prior injections of Eylea at intervals of not greater than 6 weeks for the past three injections in the eye that is selected to be the study eye; must have demonstrated the ability to achieve a dry macula in the study eye 14 days following an injection of Eylea at Screening Visit 1; Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 20 letters (20/400) or better in both eyes

Exclusion Criteria: Previous vitrectomy to the study eye; choroidal neovascularization (CNV) due to causes other than AMD; proliferative diabetic retinopathy in either eye

Information: denis@tyrogenex.com

Study: DRAW: A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet Age-related Macular Degeneration

Sponsor: University of Nebraska/Regeneron

Purpose: To study the way that aflibercept injection behaves in the eye and in the body of patients with wet macular degeneration, in patients who have had previous vitreous removal surgery

Design: Nonrandomized, Pharmacokinetics, Single Group, Open Label

Number of Patients: 15

Inclusion Criteria: Active neovascular AMD, with no history of treatment in the study eye; patients with non-vitrectomized eyes; patients with vitrectomized eyes; phakic and pseudophakic eyes are allowed in the study; willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures

Exclusion Criteria: Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion) that could affect the VEGF levels within the eye; known hypersensitivity to aflibercept; autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye; infectious conjunctivitis, keratitis, or endophthalmitis of either eye

Information: lisa.greer@UNMC.edu

Study: AVENUE: A Proof-of-Concept Study of RG7716 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration

Sponsor: Hoffman-La Roche

Purpose: To evaluate the safety, tolerability, pharmacokinetics, and efficacy of RG7716 in participants with subfoveal CNV secondary to AMD

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

Number of Patients: 271

Inclusion Criteria: Subfoveal CNV lesions of all types, secondary to AMD; active CNV

Exclusion Criteria: CNV due to causes other than AMD; subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area; cataract surgery within 3 months of Baseline, or any other previous intraocular surgery

Information: global.rochegenentechtrials@roche.com

Study: Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration

Sponsor: Neurotech Pharmaceuticals

Purpose: To compare NT-503-3 ECT to Eylea injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD

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

Number of Patients: 170

Inclusion Criteria: Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye; prior Intravitreal Anti-VEGF injections

Exclusion Criteria: Significant subretinal hemorrhage; significant Scar and/or, fibrosis; suspected polypoidal choroidopathy, or pigment epithelial tears or rips; inadequate response to anti-VEGF therapy

Information: c.johnson@neurotechusa.com

Study: Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration

Sponsor: Ohr Pharmaceutical

Purpose: To evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD

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

Number of Patients: 20

Inclusion Criteria: A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye; central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by optical coherence tomography (OCT); BCVA of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol

Exclusion Criteria: Neovascularization secondary to any other condition than AMD in the study eye; blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea; PED without associated subretinal fluid and/or cystic retinal changes; clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye

Information: 1501safety@ohrpharmaceutical.com

Study: Study of DS-7080a for the Treatment of Neovascular Age-Related Macular Degeneration

Sponsor: Daiichi Sankyo Inc.

Purpose: To test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration

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

Number of Patients: 45

Inclusion Criteria: Active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration; CNV ≥ 50% of total lesion size in study eye; central sub-field thickness > 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye

Exclusion Criteria: Presence of retinal pigment epithelial tears or rips involving the macula in the study eye; history of any vitreous hemorrhage within 4 weeks prior to screening visit in the study eye; the presence of causes of CNV other than AMD; prior vitrectomy in the study eye

Information: ssaigal@oraclinical.com

WET AMD

Study: CDER: A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular AMD

Sponsor: Allergan

Purpose: To study abicipar pegol in patients with neovascular AMD

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

Number of Patients: 900

Inclusion Criteria: Diagnosis of AMD in at least 1 eye; BCVA of 20/40 to 20/320 in the study eye and 20/200 or better in the other

Exclusion Criteria: 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

Information: clinicaltrials@allergan.com

DIABETIC MACULAR EDEMA

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

Sponsor: DRCRnet

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 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 within the prior 36 weeks; VA letter score in study eye ≤ 78 and ≥24 on clinical exam; definite retinal thickening due to DME involving the center of the macula

Exclusion Criteria: Condition where VA loss would not improve from resolution of macular edema, an ocular condition is present that, in the opinion of the investigator, might affect macular edema or alter VA during the course of the study; substantial posterior capsule opacity

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 DME

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 reduced VA resulting from retinal thickening

Exclusion Criteria: Severe impaired renal function; any intraocular condition or previous surgery that would likely require intervention during the study

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

Study: ROTATE: Ranibizumab For Persistent DME After Bevacizumab

Sponsor: Southeast Retina Center/Genentech

Purpose: To determine the safety and efficacy of intravitreally administered 0.3 mg ranibizumab in subjects with persistent DME after recent and frequent bevacizumab

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

Number of Patients: 30

Inclusion Criteria: Central-involved DME in study eye; definite retinal thickening due to DME involving the center of the macula

Exclusion Criteria: Allergy to ranibizumab; acute cardiovascular event requiring hospitalization within the past 3 months; systemic anti-VEGF or pro-VEGF treatment within 3 months

Information: dmarcus@southeastretina.com

Study: OPERA: Ozurdex for DME Treated With Pars Plana vitrEctomy and Membrane Removal

Sponsor: Cleveland Clinic/Allergan

Purpose: To examine the use of 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 PPV for: epiretinal membrane/vitreomacular traction or DME; macular edema (at least 250 µm central subfoveal thickness)

Exclusion Criteria: History of active inflammatory eye disease history of ocular malignancy and/or ocular/orbital irradiation; history of recent RVO

Information: srivass2@ccf.org

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

Number of Patients: 702

Inclusion Criteria: Best corrected E-ETDRS VA letter score ≥ 79 at two consecutive visits within 1 to 28 days; on clinical exam, definite retinal thickening

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

Information: drcrnet@jaeb.org

Study: REACT: Safety and Efficacy of Ranibizumab for DME

Sponsor: Cleveland Clinic/Genentech

Purpose: To assess the ocular and systemic adverse events of Lucentis for DME following previous treatment with Avastin

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

Number of Patients: 30

Inclusion Criteria: ETDRS BCVA of 20/25 to 20/320 in the study eye; <6 previous bevacizumab injections for DME 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

Information: DASTOLK@ccf.org

Study: A Study of MTP-131 Topical Ophthalmic Solution in Subjects With DME

Sponsor: Stealth Peptides, Inc.

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

Design: Nonrandomized, Safety/Efficacy, Open Label

Number of Patients: 21

Inclusion Criteria: Central subfield thickness ≥325 microns as measured by SD-OCT at screening and baseline visits; BCVA no better than 20/25

Exclusion Criteria: Any ocular condition that would prevent improvement in VA

Information: (617) 600-6888

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

Sponsor: River vision Development Corp.

Purpose: To evaluate the safety of teprotumumab in patients with DME

Design: Safety, Single Group, Open Label

Number of Patients: 10

Inclusion Criteria: Clinically significant DME of less than 12 months duration; non-PDR of moderate severity

Exclusion Criteria: Systemic anti-VEGF treatment within four months prior to enrollment; history of PRP 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 DME

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: BCVA of 20/50 to 20/320 ETDRS equivalent in the study eye, with BCVA decrement primarily attributable to DME; treatment naïve

Exclusion Criteria: Active PDR in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma; uncontrolled hypertension

Information: (949) 940-8130

Study: VIDI: A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With DME

Sponsor: Astellas Pharma Europe BV

Purpose: To evaluate efficacy and safety of ASP8232 in subjects with DME

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

Number of Patients: 84

Inclusion Criteria: Subject has definite retinal thickening due to diffuse DME involving the central macula based on evaluating investigator’s clinical evaluation and demonstrated by SD-OCT

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

Information: Astellas.registration@astellas.com

Study: DIME: Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema

Sponsor: California Retina Consultants

Purpose: To compare the effectiveness of using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema

Design: Randomized, Efficacy, Parallel Assignment, Open Label

Number of Patients: 40

Inclusion Criteria: Clinical evidence of retinal thickening due to macular edema involving the center of the macula associated with diabetic retinopathy; previous history of anti-vegf treatment for DME with documented incomplete resolution of central subfield thickening by SD-OCT

Exclusion Criteria: Evidence of vitreoretinal interface abnormality contributing to the macular edema; an eye thathas no chance of improving in VA following resolution of macular edema

Information: sarahf@californiaretina.com

Study: PALADIN: Phase 4 IOP Signals Associated With ILUVIEN

Sponsor: Alimera Sciences

Purpose: To assess the safety in patients treated with ILUVIEN, with primary focus on IOP

Design: Nonrandomized, Safety, Single Group, Open Label

Number of Patients: 300

Inclusion Criteria: Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information

Information: kathleen.billman@alimerasciences.com

Study: REACT: Safety and Efficacy of Ranibizumab for DME

Sponsor: Justis Ehlers/Genentech

Purpose: To assess ocular and systemic adverse events of ranibizumab for DME following previous treatment with bevacizumab

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

Number of Patients: 30

Inclusion Criteria: ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye; at least 6 previous bevacizumab injections for DME in the last 12 months

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

Information: stiegel@ccf.org

Study: ERASER: Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab

Sponsor: California Retina Consultants

Purpose: To evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema

Design: Efficacy, Single Group, Open Label

Number of Patients: 60

Inclusion Criteria: Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy; central DME present on clinical examination or or evidence indicating disease activity on spectral domain OCT

Exclusion Criteria: Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study

Information: crcjgiust@yahoo.com