Article

CLINICAL TRIAL UPDATE

DRY AMD

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 AMD in the non-study eye requiring any treatment within 12 months prior to Day 0

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 AMD

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: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With AMD

Sponsor: National Eye Institute

Purpose: To see if minocycline is safe for people with GA and if it helps preserve their vision

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

Number of Patients: 66

Inclusion Criteria: Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes; participant must be able to swallow capsules

Exclusion Criteria: Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (eg, ethambutol, chloroquine, or hydroxychloroquine); participant has a condition that would preclude participation in the study

Information: meg.gordon@nih.gov

Study: Evaluation of Lipoic Acid as a Treatment for Geographic Atrophy

Sponsor: University of Pennsylvania

Purpose: To determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic acid are taken by subjects 65 years of age or older

Design: Safety, Single Group, Open Label

Number of Patients: 15

Exclusion Criteria: Blood pressure greater than 190/100 at the baseline visit; pulse greater than 100 at the baseline visit; acute and ongoing systemic infection; history of dementia; participant has a condition that, in the opinion of the investigator, gives them an unstable medical status; participant has geographic atrophy and the investigator believes the participant is a candidate for enrollment into the planned Phase 2 trial for geographic atrophy

Information: benjamin.kim@uphs.upenn.edu

Study: A Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura® (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Sponsor: Ophthotech

Purpose: To evaluate the safety and efficacy of intravitreous administration of Zimura when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration

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

Number of Patients: 300

Inclusion Criteria: Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria: Retinal atrophy involving the fovea; evidence of CNV; any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals; any intraocular surgery or thermal laser within 3 months of trial entry; any prior thermal laser in the macular region, regardless of indication; any ocular or periocular infection in the 12 weeks prior to entry; previous therapeutic radiation in the region of the study eye; any sign of diabetic retinopathy in either eye

Information: Desiree.Beutelspacher@Ophthotech.com

Study: BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

Sponsor: DuBois Vision Clinic

Purpose: To evaluate the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally

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

Number of Patients: 616

Inclusion Criteria: Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye; confirmed diagnosis of Dry MD; vision loss attributable to Dry MD

Exclusion Criteria: Any retinal pathology other than Dry MD; evidence or history of wet MD; previous intravitreal injection; seizure disorders; dense cataract; eyelid pathology at the treatment sites

Information: telephonescreener@outlook.com

Study: PRO-CON: IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD

Sponsor: Jeffrey S. Heier, MD/Regeneron

Purpose: To evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in “high-risk” subjects

Design: Randomized, Parallel Assignment, Single-blind

Number of Patients: 128

Inclusion Criteria: Study eye must have a diagnosis of non-exudative age-related degeneration characterized by the presence of many intermediate sized drusen, 1 or more large drusen, and/or hyperpigmentary changes. Fellow (non-study) eye must have CNV lesion (i.e., leakage on fluorescein angiography and/or subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration OR history of CNV lesion secondary to age-related macular degeneration, as confirmed by current or past treatment or current or past diagnostic imaging

Exclusion Criteria: Evidence of neovascular AMD in the study eye at time of enrollment or anytime in the past. The reading center must confirm that there is no evidence of neovascular AMD in the study eye prior to enrollment; serous PED of any size in the study eye, as determined by the reading center; previous treatment with verteporfin PDT, anti-VEGF therapy, laser, external beam radiation or other AMD therapy in the study eye

Information: anowak@eyeboston.com

Study: PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy

Sponsor: Janssen Research & Development, LLC

Purpose: To evaluate the safety and performance profile of a modified surgical procedure and custom delivery devices and also to assess the effects on visual acuity of a single subretinal administration of CNTO 2476

Design: Randomized, Parallel Assignment, Double-blind

Number of Patients: 255

Inclusion Criteria: Confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 28 days prior to initial randomization by the central reading center; study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. BCVA in the treatment eye must be worse than the BCVA in the fellow eye at screening

Exclusion Criteria: Participant has a history of neovascular (“wet”) AMD in the treatment eye, including any evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening; geographic atrophy secondary to any causes other than AMD in either eye

Information: https://jnj.prod.sylogent.com/scr/Home.aspx?CR106814

Study: METforMIN: Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD

Sponsor: University of California, San Francisco

Purpose: To determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in non-diabetic patients with age-related macular degeneration

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

Number of Patients: 100

Inclusion Criteria: Subject must have evidence of advanced dry AMD, defined by the characteristic presence of drusen and/or pigmentary changes, as well as geographic atrophy; subject must have clear ocular media and adequate pupillary dilation; study eye must have best corrected visual acuity (BCVA) of 20/20 to 20/400

Exclusion Criteria: Subjects with insufficient baseline size of geographic atrophy, less than 1.25 mm2 (0.5 Macular Photocoagulation Study Disc Areas). GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in its entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements

Information: eyestudy@ucsf.edu

Study: An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration

Sponsor: Stealth BioTherapeutics

Purpose: To test 40 mg of elamipretide administered as a once daily 1.0 mL subcutaneous injection for 12 weeks

Design: Safety, Single Group, Open Label

Number of Patients: 40

Inclusion Criteria: No evidence of choroidal neovascularization (active or prior history) in the study eye; geographic atrophy may be multifocal, but the cumulative GA lesion size must be: ≥ 1.27 mm2 (approximately ≥ 0.5 DA) and ≤ 10.16 mm2 (approximately ≤ 4 DA); must reside completely within the FAF imaging field (field 2 to 30-degree image centered on the fovea); presence of measurable hyperautofluorescence adjacent to the discrete foci of GA. OR Intermediate AMD - high-risk drusen without GA disease group

Exclusion Criteria: Age-related macular degeneration with any evidence of central GA (i.e., involving the fovea); atrophic retinal disease because of causes other than AMD; presence or diagnosis of exudative AMD or choroidal neovascularization in the study eye; history of diabetic retinopathy (a history of diabetes mellitus without retinopathy is not a criterion for exclusion); presence of vitreous hemorrhage; history of retinal detachment or macular hole (stage 3 or 4) in the study eye; presence of macular pucker

Information: kit.oldham-creamer@stealthbt.com

WET AMD

SStudy: Study of DS-7080a for the Treatment of Neovascular AMD

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 CNV lesions secondary to AMD; CNV ≥ 50% of total lesion size in study eye; central sub-field thickness > 315 µm on SD-OCT in the study eye

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

Information: ssaigal@oraclinical.com

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; presence of sub-retinal hyper-reflective material (SD-OCT)

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); any intraocular surgery or thermal laser within 3 months of trial entry; any prior thermal laser in the macular region

Information: Karen.Lewis@ophthotech.com

Study: PREVENT: Prophylactic Ranibizumab for Exudative AMD

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), etc.

Information: mlalezary@desertretina.com

Study: X-82 to Treat AMD

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 that 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; ETDRS 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 AMD

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 AMD

Sponsor: Hoffman-La Roche

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

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

Information: global.rochegenentechtrials@roche.com

Study: A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative AMD

Sponsor: Santen Inc.

Purpose: To evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration

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

Number of Patients: 12

Inclusion Criteria: Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration; prior treatment in the study eye with any intravitreal anti-VEGF medication; at least one lesion in the study eye that meets minimal pathology criteria

Exclusion Criteria: Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1; uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye

Information: clinicaltrials@santeninc.com

Study: LADDER: Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular AMD

Sponsor: Genentech

Purpose: To evaluate the efficacy and the safety of three different formulations of ranibizumab, delivered via the Ranibizumab Port Delivery System (RPDS) implant, in patients with subfoveal neovascular age-related macular degeneration

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

Number of Patients: 220

Inclusion Criteria: Newly diagnosed with wet AMD within 6 months of screening visit; patient must have received at least two ranibizumab injections within approximately 2 months prior to the screening visit; patient may have received up to six ITV anti-VEGF injections prior to the screening visit; demonstrated response to prior standard of care

Exclusion Criteria: Study eye treatment with ITV bevacizumab within 5 months prior to the randomization visit, or with ITV aflibercept within 3 months prior to the randomization visit; history of laser photocoagulation, Visudyne, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD

Information: (888) 662-6728

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: Untreated or previously treated choroidal neovascularization (CNV) lesion due to AMD; BCVA of approximately 20/200 Snellen or better in the non-study eye; 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

Study: Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD

Sponsor: RXi Pharmaceuticals

Purpose: To evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration

Design: Safety/Efficacy, Open Label, Single Group

Number of Patients: 9

Inclusion Criteria: Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/200 potentially due to subretinal fibrosis involving the fovea; BCVA ≥20/800 in the contralateral eye and better than the study eye; ≥50 years of age; subfoveal CNV of any type

Exclusion Criteria: Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis

Information: clinicaloperations@rxipharma.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: Safety, Single Group, Open Label

Number of Patients: 10

Inclusion Criteria: Patients with subfoveal neovascular membranes identified on fluorescein angiography; visual acuity (best corrected vision) 20/200 or worse in affected eye; patient must be 50 years of age or older at time of consent; 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: EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection

Sponsor: University of California-San Diego/Regeneron

Purpose: To evaluate individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration

Design: Single Group, Open Label

Number of Patients: 100

Inclusion Criteria: Naïve neovascular wet-age-related macular degeneration (has not received treatment before)

Exclusion Criteria: Previous therapy in study eye for age-related macular degeneration or other retinal disease which may be used in the treatment of age-related macular degeneration; previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; history of vitrectomy, submacular surgery, or other surgical intervention for age-related macular degeneration in the study eye; any concurrent intraocular condition in the study eye

Information: cwen@ucsd.edu

WET AMD

Study: Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration

Sponsor: SciFluor Life Sciences

Purpose: To evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD)

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

Number of Patients: 40

Inclusion Criteria: Active subfoveal choroidal neovascularization due to Age-related Macular Degeneration (AMD) that meet the following criteria: total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas; choroidal neovascularization (CNV) >50% of lesion area; intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on optical coherence tomography (OCT) No atrophy or fibrosis involving the center of the fovea; best-corrected Visual Acuity (BCVA) of 0.3 to 1.2 Early Treatment Diabetic Retinopathy Study (ETDRS; Logarithmic minimum angle of resolution [logMAR]) in the study eye, with BCVA decrement primarily attributable to neovascular Age-related Macular Degeneration (AMD); treatment naïve (i.e., no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye) or previously treated study eye

Exclusion Criteria: Fellow eye visual acuity (VA) worse than 1.3 Early Treatment Diabetic Retinopathy Study (ETDRS), Logarithmic minimum angle of resolution (logMAR) (ie, 35 letters equivalent); choroidal neovascularization (CNV) in the study eye secondary to other causes (eg., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis); previous macular laser photocoagulation or ocular photodynamic therapy in the study eye; media opacities or abnormalities that would preclude visualization of the retina; other retinal pathologies that would interfere with vision

Information: clinicaltrials@scifluor.com

DIABETIC MACULAR EDEMA

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

Sponsor: Jaeb Center for Health Research

Purpose: To compare the percentage of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better

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

Number of Patients: 702

Inclusion Criteria: Best corrected E-ETDRS visual acuity 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 involving the center of the macula; diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days. (a) Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality

Exclusion Criteria: Macular edema is considered to be due to a cause other than DME. a) An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (eg, a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema; an ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition); an ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)

Information: www.jaeb.org

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

Sponsor: Jaeb Center for Health Research

Purpose: To assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and visual acuity impairment despite previous anti-VEGF treatment

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

Number of Patients: 125

Inclusion Criteria: At least three injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 20 weeks; visual acuity 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; OCT CSF thickness, within 8 days of enrollment: i) On Zeiss Cirrus ≥ 290 microns in women; ≥ 305 in men ii) On Heidelberg Spectralis: ≥ 305 microns in women; ≥ 320 in men

Exclusion Criteria: Macular edema is considered to be due to a cause other than DME. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema; an ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition, etc.); an ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)

Information: www.jaeb.org

DIABETIC MACULAR EDEMA

Study: Anti-VEGF Treatment for Prevention of PDR/DME

Sponsor: Jaeb Center for Health Research

Purpose: To determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications

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

Number of Patients: 322

Inclusion Criteria: No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed); no evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization. The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned; no center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds

Exclusion Criteria: Exam or photographic evidence of vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR; history of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR; history of prior PRP (defined as ≥100 burns outside of the posterior pole); an ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (eg, retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.)

Information: www.jaeb.org

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

Sponsor: Allergan/California Retinal Consultants

Purpose: To compare the effectiveness of using a dexamethasone steroid implant vs 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 diabetic macular edema (DME) with documented incomplete resolution of central subfield thickening by spectral-domain optical coherence tomography (SD-OCT). At least four intravitreal anti-vegf injections within the past 6 months prior to the baseline study visit are required for eligibility; central diabetic macular edema present on clinical examination and SD-OCT testing with central 1 mm subfield thickness greater than 300 microns as measured on SD-OCT at the baseline visit; visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 74 letters (20/32) by the ETDRS visual acuity protocol

Exclusion Criteria: An eye that, in the investigator’s opinion, has no chance of improving in visual acuity following resolution of macular edema (eg, presence of subretinal fibrosis or geographic atrophy); presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (eg, AMD, uveitis, Irvine-Gass); evidence of active neovascularization of the iris or retina; evidence of central atrophy or fibrosis in the study eye; presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study; history of vitreous surgery in the study eye

Information: sarahf@californiaretina.com

Study: HULK: Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

Sponsor: Clearside Biomedical, Inc.

Purpose: To demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus

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

Number of Patients: 20

Inclusion Criteria: DME with central involvement in the study eye; ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye

Exclusion Criteria: Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye; history of any previous ophthalmic surgeries in the study eye within 90 days of screening; subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only); subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)

Information: kathleen.billman@clearsidebio.com

Study: Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Diabetic Macular Edema

Sponsor: SciFluor Life Sciences

Purpose: To evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with diabetic macular edema

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

Number of Patients: 40

Inclusion Criteria: Retinal thickening secondary to type 1 or type 2 diabetes mellitus with diabetic macular edema (DME) defined as central subfield thickness ≥325 microns (µm) on spectral domain OCT; best-corrected Visual Acuity (BCVA) of 0.3 to 1.2 Early Treatment Diabetic Retinopathy Study (ETDRS; Logarithmic minimum angle of resolution [logMAR]) in the study eye, with BCVA decrement primarily attributable to DME; treatment naïve (ie, no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye)

Exclusion Criteria: Active proliferative diabetic retinopathy (PDR) in the study eye, such as neovascularization of the optic disc (NVD), neovascularization elsewhere (NVE), vitreous hemorrhage, or neovascular glaucoma; previous panretinal photocoagulation (PRP) in study eye or the need for panretinal photocoagulation (PRP) within 2 months from the time of study enrollment, based on the Investigator’s opinion; previous focal laser photocoagulation within the foveal avascular zone; uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive measurements (during the same visit) or diastolic >100 mmHg on optimal medical regimen; screening glycated hemoglobin (HbA1c) blood test >12.0%; focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment

Information: clinicaltrials@scifluor.com

Study: Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With Diabetic Macular Edema

Sponsor: Arshad Khanani, MD, Sierra Eye Associates/Genentech

Purpose: To compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME

Design: Randomized, Parallel Assignment, Single-blind

Number of Patients: 100

Inclusion Criteria: Exam and OCT confirming diabetic macular edema; visual acuity of 20/400 or better; no history of post injection pain or inflammation in the past

Exclusion Criteria: History of endophthalmitis in either eye; current inflammation in either eye; uncontrolled or symptomatic dry eye syndrome; intravitreal injection less than 3 months ago; history of anterior or posterior uveitis; history of post injection pain with prior treatments; recent thromboembolic event (<3 months)

Information: arshad.khanani@gmail.com

Study: PERMEATE: Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO

Sponsor: Justis Ehlers/Regeneron

Purpose: To evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion

Design: Safety/Efficacy, Single Group, Open Label

Number of Patients: 30

Inclusion Criteria: Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SD-OCT; ETDRS BCVA of 20/25 to 20/400 in the study eye

Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye; prior panretinal photocoagulation in the study eye; prior intravitreal anti-VEGF therapy in the study eye; prior focal/grid laser photocoagulation

Information: reesej3@ccf.org

Study: Swap Two: Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab

Sponsor: Rishi Singh, MD, Cleveland Clinic Foundation/Regeneron

Purpose: To evaluate the safety and efficacy of treatment of diabetic macular edema with intravitreal aflibercept in subjects previously treated with intravitreal anti-VEGF agents (ranibizumab or bevacizumab)

Design: Single Group, Open Label

Number of Patients: 20

Inclusion Criteria: Foveal-involving retinal edema secondary to DME based on investigator review of clinical exam and SDOCT with central subfield thickness value of 325 microns by Zeiss Cirrus SD-OCT; E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye; history of previous treatment with anti-VEGF with at least four injections over the last 6 months

Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME in the study eye; prior panretinal photocoagulation in the study eye within the past 3 months; prior intravitreal anti-VEGF therapy in the study eye within 30 days of enrollment; prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study; previous treatment with intravitreal aflibercept injection; significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam

Information: mcowend@ccf.org

Study: FAD: Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema

Sponsor: Johns Hopkins University

Purpose: To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME) and to collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Design: Safety/Efficacy, Single Group, Open Label

Number of Patients: 50

Inclusion Criteria: Subjects receiving Iluvien as standard of care for DME

Information: pcampo@jhmi.edu